Proactiveinvestors USA & Canada column

US FDA Staff Shoot Down Pfizer Rare Disease Drug; Repros Updates Special Protocol Assessment Studies for Androxal

Wed, 23 May 2012 14:41:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on May 22, 2012.

U.S. drug reviewers recommended on Tuesday rejecting a Pfizer Inc (NYSE:PFE) drug because the data did not prove it worked well in treating a rare neurodegenerative disease.

The U.S. FDA staff reviewed the drug, tafamidis, ahead of an advisory panel of outside experts, which will vote on whether to recommend it for approval on Thursday. The FDA will make a final decision later, taking into account the panel's recommendation.

Tafamidis, which is already approved in Europe under the name Vyndaqel, is meant to treat familial amyloid polyneuropathy, a fatal condition that affects about 8,000 people worldwide, according to Pfizer.

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Repros Therapeutics Inc.® (Nasdaq: RPRX) announced it has modified the pivotal protocol following additional FDA input post the May 9th meeting. The revision included additional secondary endpoints specifying the number of men in the study that exhibit a single time point of testosterone concentration greater than 1500, 1800 and 2500 ng/dL. It is common to experience such high excursions for approved topical products. No subject in an Androxal® study has ever exhibited a concentration greater than 1500 ng/dL and the maximum levels achieved are approximately 1100 ng/dL.

This level occurs rarely and only in men administered the higher (25 mg) dose. The pivotal studies are designed to titrate men to greater than 450 ng/dL by first starting on the 12.5 mg dose. The Company believes 60% of men will achieve the 450 ng/dL up-titration threshold on the 12.5 mg dose resulting in 40% of men up-titrating to the 25 mg dose.

Also Tuesday:

BioTime, Inc. (NYSE MKT: BTX) today announced that its subsidiary LifeMap Sciences, Inc. has entered into a license agreement with Yeda Research and Development Company Ltd, the technology transfer arm of the Weizmann Institute of Science, to market a new database called MalaCards.

Celgene Corporation (NASDAQ: CELG) today announced its presentation at Sanford C. Bernstein’s 28th Annual Strategic Decisions Conference on Wednesday, May 30, 2012 at 3:00p.m. EST will be webcast live and will be available in the investor relations section of the Company’s Web site at www.Celgene.com.

Codexis, Inc. (NASDAQ:CDXS), a developer of cost-advantaged processes for the production of biofuels, bio-based chemicals and pharmaceuticals, today announced a three-year extension of its catalyst and process development collaboration with Merck to develop enzymes for use in pharmaceutical manufacturing.

Covidien plc (NYSE: COV) today announced that its wholly-owned subsidiary, Covidien International Finance S.A. (CIFSA), priced an underwritten offering of $600 million aggregate principal amount of 1.350% senior notes due 2015 and $650 million aggregate principal amount of 3.200% senior notes due 2022.

Deltagen, Inc. (Pink Sheets:DGEN), a leading provider of drug discovery tools and services to the biopharmaceutical industry, today reported unaudited consolidated financial results for the three months ended March 31, 2012.

Emergent BioSolutions Inc. (NYSE: EBS) announced today that the company will be webcasting its presentation at the Jefferies 2012 Global Healthcare Conference in New York on Tuesday, June 5, 2012 at 10:30 AM Eastern.

FLIR Systems, Inc.(NASDAQ: FLIR) announced today that it has been awarded an indefinite delivery, indefinite quantity contract from the U.S. Army to support the MEDEVAC program.

Galectin Therapeutics (NASDAQ: GALT) will host a conference call at 10:00 A.M. Eastern Time on Thursday, May 24, 2012, to provide an update following the Company’s Annual Meeting of Shareholders.

Genetic Technologies Limited (ASX: GTG) (NASDAQ: GENE) is pleased to provide an update on BREVAGen™ sales and the "credentialing" process with the top ten U.S. Preferred Provider Organizations ("PPOs").

GeoVax Labs, Inc. (otcqb/otcbb:GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, today announced that the NIH-funded HIV Vaccine Trials Network (HVTN) has opened enrollment for a Phase 1 trial for the company's second-generation HIV vaccine.

Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced several new studies using PillCam® COLON 2, including data evaluating its viability as an out-of-clinic procedure.

Impax Laboratories, Inc. (NASDAQ: IPXL) held its 2012 Annual Meeting of Stockholders today in San Mateo, California. Impax stockholders elected to a one-year term each of the seven nominees for director named in the Company’s proxy statement, approved, on an advisory basis, the compensation of the Company’s named executive officers as described in the proxy statement (“say-on-pay” vote) and ratified the appointment of KPMG LLP as independent auditors for the fiscal year ending December 31, 2012.

Medtronic, Inc. (NYSE:MDT) today announced financial results for its fourth quarter and fiscal year ended April 27, 2012.

Pegasystems Inc. (NASDAQ: PEGA), the leader in Business Process Management (BPM) and software for customer centricity, today announced that Amerigroup Corporation has significantly increased its claims first-pass rate within just three months of deploying Pega Claims Repair, and is on track for even higher efficiencies in the near future.

Pfizer Inc. (NYSE: PFE) and EatingWellMedia Group, publisher of EatingWell Magazine and part of Meredith Corporation (NYSE: MDP), today announced the launch of Pfizer's Lipitor For You"Recipes 2 Go"mobileapplication ("app"), marking the first time Pfizer has released a consumer mobile app for a prescription product in the U.S.

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that John R. Plachetka, Pharm.D., the Company’s Chairman, President and Chief Executive Officer, will present at the Jefferies 2012 Global Healthcare Conference on Tuesday, June 5, 2012 at 10:30 a.m. (ET), in New York City.

Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, today announced that its annual meeting of shareholders will be held on Thursday, May 24, 2012 at 8am EDT at the Radnor Hotel in St. Davids, PA.

Sunshine Biopharma Inc. (OTCBB: SBFM) a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has completed the pharmacokinetics studies in live rats for its lead anti-tumor compound, Adva-27a.

As Darling Dendreon Takes Hits Others Continue To Thrive

Tue, 22 May 2012 13:48:00 -0400

Recently considered biotech’s immunotherapy darling, shares of Dendreon Corporation have been taking a beating. Does this mean the end of the road or opportunity for others in the same space?

Currently trading -82.18 % from their 52-Wk High ($ 42.87), the stock was hit with even more bad coverage late last week when the Maxim Group’s Jason Kolbert initiated coverage on the company with a "Sell" warning and a lowly $5 price target.

“Dendreon is a pioneer in the cancer field, delivering the first cancer-immunotherapy to the marketplace,” wrote Kolbert in his research report. “Unfortunately, the therapy – Provenge – is highly complex with logistic and manufacturing obstacles that will likely take years to resolve and may hold it back from biotech-like margins. In the interim period, the competitive landscape is moving forward with cheaper, potentially more efficacious and easier-to-administer therapies, many of which are oral pills. However, we believe it may become increasingly difficult for Provenge to acquire market share and grow. With a high cost structure and little leverage, we see more downside than upside over the coming year.”

Other emerging cancer-immunotherapy companies in Phase II like glioblastoma treatment rivals ImmunoCellular Therapeutics (OTCBB:IMUC) and Northwest Biotherapeutics (OTCBB:NWBO) have gone out of their way to let investors know that they plan to employ less taxing manufacturing processes, but the market, generally speaking, has not been kind to the immunotherapy sector without much regard for details.

Even Phase III stage, Cel-Sci (AMEX:CVM), who had seen its shares rising steadily since the beginning of the year, saw prices pushed lower after the DNDN report. Unlike the personalized approach used by Dendreon, CVM’s Multikine treatment aims to be mass produced in the Company’s pricey, cutting edge (cold-fill) manufacturing plant. That drug would be given for 3 weeks before any other cancer therapies (surgery, radiation and/or chemotherapy) because previous trials show that would appear to be an ideal time to produce an effective immune response. While Multikine may well represent the next class of generation immunotherapy drugs, the stock may not be as de-risked as some may like until they raise enough money to completely finish the expensive, world-wide Phase III trial they are running with partners Teva Pharmaceuticals (Israel) and Orient Europharma (Taiwan). So far, in these choppy market environments, they have managed only to raise money on an "as-needed" basis. But if a partner like Teva, or a large hedge fund or perhaps even a quantifiable biotech investor steps in with a substantial (and favorable!) financing deal which can carry the company through the rest of Phase III, it could be a game changer. At the very least it would signal a huge bullish bet for a technology that has taken decades to reach Phase III.

“The process of manufacturing Provenge is labor intensive,” explains Maxim's Kolbert. “It is too early to predict that margins will rise as the easy automation (sample tracking) is not the core problem. The key question is: Will Dendreon have time to lower (Cost of goods sold ) COGS?”

Further complicating the issue for DNDN is the fact that Dendreon's approved drug only targets PAP on prostate cancer, but if PAP expression is switched off by cell, it will no longer be effective.

Other early developers, like TapImmune (OTCBB:TPIV) have product candidates (the TAP vaccine) which perform a key step in moving these characteristic markers (antigens) to the surfaces of cells. The theory is that without TAP, there are no cancer markers, so the immune system fails to spot the rogue cells and the cancerous cells can grow undetected. One of the firm’s vaccines has shown effective restoration of TAP which restores and augments the marker (antigen) presentation and subsequent recognition and killing of cancer cells by the immune system, but a recently announced Phase I trial will test a novel set of HER2/neu Class II antigens that has doctors there and at the Mayo Clinic excited.

While a vast majority of the immunotherapy products which are being promoted and hyped to retail investors are still years away, speculators often get excited about the possibilities and we see those penny stocks run many times higher than logic should allow at random times during the year.

Shares of Galena Biopharma (NASDAQ:GALE) had been on an impressive run as one of the leaders in YTD performance, before an analyst warned investors that promoters were being paid to heavily promote the company and that a highly dilutive financing was on the way. The story folded out as predicted and GALE shares have lost nearly two-thirds of their traded value since.

For companies like Dendreon, the most visible upcoming catalyst is the possible approval of Provenge in Europe. That event is highly anticipated later this year, but most of the catalysts for DNDN will be provided by news of progress from other products in development. Those products are oral and cheaper and even the Maxim analyst agrees that they have potentially equal or better efficacy. As other products start to look good, it may drive Provenge forecasts lower.

In a recent interview ImmunoCellular’s CEO Manish Singh stated "I truly believe Dendreon was instrumental in opening the doors for small companies like us to build the next generation of immunotherapy product by building on its success."

DNDN is most often the sample pointed to for biotech trading profits potential. They were, afterall, the first company to deliver an approved autologous immunotherapy (April 2010) based on activating a patient’s own (dendritic) cells. Now that the company tries to find its way during the commercialization questions still exist about its role in the prostate cancer treatment paradigm.

The fact that speculators are still willing to bet on immunotherapies has other deals moving along as well. On Monday, shares of Genesis Biopharma, Inc. (OTCBB: GNBP) rose 30% after the firm let the market know that they were still planning to move their targeted cancer immunotherapy directly into Phase III. The ready-to-infuse autologous cell therapy ("ACT") which utilizes tumor infiltrating lymphocytes ("TILs") for the treatment of patients with Stage IV metastatic melanoma is based on a physician-sponsored investigational therapy currently available at the National Cancer Institute ("NCI"), MD Anderson Cancer Center and the H. Lee Moffitt Cancer & Research Institute for this same indication. If that firm manages to actually pull off their ambitious plan, speculators may continue to notice.

There are also rumors that another firm (name withheld) with late-stage immunotherapy currently under a clinical hold placed by the FDA may be close to negotiating a deal to get those hand-cuffs removed. Unfortunately, these are the type of highly-speculative plays that get those who are looking for multi-baggers excited— most often defying logic or sense.

For now, Maxim feels that while Dendreon’s Provenge “is an innovative and exciting new breakthrough, its trial-based efficacy is marginal, its cost of goods is very high, and treatment protocols are arduous.”

As always, trade with caution and pay close attention to the details. Do these firms conduct science in a luxury office or do they actually have labs, for example? The devil is often in the most simple details that most traders overlook.

Video Q&A: Brian M. Culley, CEO of Adventrx Pharmaceuticals

Thu, 17 May 2012 15:42:00 -0400

Shares of Adventrx Pharmaceuticals Inc (Amex:ANX) are trading -87.41 % from their 52-Wk High ($ 4.21). With two possible pending Phase III trial initiations on-tap and some recent insider buying, it appears the heavily shorted stock may be a good bottom bounce candidate at today's price levels.

ADVENTRX Pharmaceuticals

0.54 +0.00 (+0.92%)

The specialty pharmaceutical company's product portfolio includes: ANX-530 or Exelbine(TM), a novel emulsion formulation of the chemotherapy drug vinorelbine indicated for treatment of advanced non-small cell lung cancer; ANX-514, a novel emulsion formulation of the chemotherapy drug docetaxel indicated for the treatment of advanced cancer; and ANX-188, a novel, purified, rheologic and antithrombotic compound initially being developed as a first-in-class treatment for pediatric patients with sickle cell disease in acute crisis.

Brian M. Culley, the firm's CEO and Director sat down with BioMedReports to talk about his firm and the antithrombotic and rheologic polymer (ANX-188) which they are planning to test in sickle cell disease soon.

"It's a very interesting drug," explains Culley. "It has the ability to bind to damaged portions on cells, in particular red cells and white cells in the blood stream. What it does is it acts like a membrane sealant. It binds to damaged regions and sort of coats or protects them. By doing so, it lowers viscosity. When you have lower viscosity in the blood stream, your cells are able to transport more easily and they can do their job such as deliver oxygen to tissues. So it is a drug that allows the cells to deliver oxygen to tissues when otherwise they would have some difficulty in doing so due to viscosity. So it lowers viscosity of the cells in the blood stream."

The full interview with Culley can be seen below:

Pfizer's Phase III Study Didn't Meet Primary Endpoint; Boston Scientific Announces Positive Data

Wed, 16 May 2012 13:25:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on May 15, 2012.

Pfizer Inc (NYSE:PFE) announced the Phase 3 INTORSECT (B1771003) study, evaluating TORISEL^® (temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after SUTENT^® (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib.

Although PFS was numerically higher in patients treated with temsirolimus, the difference was not statistically significant. Overall survival, a secondary endpoint in the study, showed statistical significance favoring patients randomized to the sorafenib arm. Adverse events in this study were consistent with the known safety profiles for both drugs. Full efficacy and safety data from this study will be presented at an upcoming major medical congress.

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Boston Scientific Corporation (NYSE: BSX) announces results from the REPRISE I feasibility trial, which evaluated the acute safety of the Lotus™ Aortic Valve System in patients with severe aortic valve disease.

The Lotus Aortic Valve System is the first transcatheter aortic valve replacement (TAVR) device of its kind that is designed to minimize aortic regurgitation (leaking) and is both fully repositionable and retrievable prior to release. Data presented today at the annual EuroPCR Scientific Program in Paris demonstrated successful deployment of the valve in all patients with virtually no paravalvular regurgitation after valve placement or at discharge.

Also Tuesday:

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will host a live webcast of its Educational Program on Parkinson’s Disease Psychosis to be held with analysts and investors in New York City on Tuesday, May 22, 2012, from 12:00 p.m. to 1:15 p.m. Eastern Time.

Accelr8 Technology Corporation (NYSE MKT: AXK) and Denver Health received notice that the Defense Medical Research and Development Program (DMRDP) recommended $2 million funding of a proposed 35-month project submitted jointly by Denver Health and Accelr8.

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has retired approximately $4.5 million in aggregate convertible debt due on May 12, 2012, October 31, 2012, and January 9, 2013.

American Bio Medica Corporation (ABMC.PK) today announced financial results for the three months ended March 31, 2012.

Antares Pharma, Inc. (NYSE Amex: AIS) today announced the appointment of LeRoux Jooste to the position of Senior Vice President of Pharmaceutical Sales and Marketing.

BioLargo, Inc. (OTCBB: BLGO), creator of patented iodine technologies, today announced the development of novel antimicrobial products for the advanced wound care industry and the formation of a wholly owned subsidiary BioLargo Medical Group, Inc., formed to advance proof of claims and pursue regulatory approvals.

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, today reported its results for the quarter ended March 31, 2012.

Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), today announced that it has been named one of the "2012 Best Places to Work in the Bay Area" by a joint project of the San Francisco Business Timesand the Silicon Valley/San Jose Business Journal.

Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s biologics manufacturing facility in Devens, Massachusetts for commercial production of ORENCIA® (abatacept).

Cardium Therapeutics (NYSE Amex: CXM) today presented its financial results for the first quarter ended March 31, 2012, and other recent developments.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the Company will be added to the NASDAQ Biotechnology Index® (NBI), effective prior to market open on Monday, May 21, 2012.

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced a reverse split of its common stock at a ratio of 1-for-7.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today reported financial and operating results for the three months ended March 31, 2012.

Fibrocell Science, Inc. (OTCBB:FCSC.OB) announced today the formation of the Clinical Investigations for Dermal Mesenchymally-Obtained Derivatives (CIDMOD) Initiative (www.CIDMOD.org) in collaboration with researchers from a number of different universities across the U.S.

Galectin Therapeutics (NASDAQ: GALT) (“the Company”), the leader in developing carbohydrate-based therapeutic compounds to inhibit galectin proteins for the therapy of liver fibrosis and cancer, today announced that the first patient has been dosed in a Phase 1/2 trial evaluating the safety and efficacy of a novel treatment combination for the treatment of advanced metastatic melanoma.

Generex Biotechnology Corporation (OTCBB: GNBT), in anticipation ofthe transition into pivotal Phase III trials, is pleased to announce today that the expertise of the Scientific Advisory Board (SAB) of its wholly-owned subsidiary, Antigen Express, Inc., has been expanded by the addition of two globally recognized experts in clinical trial research and immuno-therapeutic treatments of breast cancer.

GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced its financial results for the three months ended March 31, 2012 and provided a business update.

Greatbatch, Inc. (NYSE: GB), today announced that Mr. Thomas J. Hook, President and CEO will present at the Bank of America Merrill Lynch 2012 Health Care Conference in Las Vegas, NV on Tuesday, May 15, 2012, at 11:20 a.m. Pacific Time.

IGI Laboratories, Inc. (NYSE Amex: IG), a New Jersey based topical generic drug development and manufacturing company, provided its financial results for the first quarter ended March 31, 2012.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that the company will be added to the NASDAQ Biotechnology Index® (NBI).

InVivo Therapeutics Holdings Corp. (OTCBB:NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today reported the financial results for the three months ended March 31, 2012 and provided a business update.

International Stem Cell Corporation (OTCBB: ISCO) (www.internationalstemcell.com) today announced that several of its leading scientists will present experimental results from three of ISCO’s pre-clinical therapeutic programs.

MeadWestvaco Corporation (NYSE: MWV), a global leader in packaging and packaging solutions, will present at Pharmapack North America’s inaugural conference at the Pennsylvania Convention Center in Philadelphia, May 22 – 23, 2012.

Medtronic (NYSE: MDT) will host an institutional investor and analyst meeting on Friday, June 1, 2012, in New York City from 9:00 a.m. to approximately 1:00 p.m. Eastern Daylight Time.

NeuroMetrix, Inc. (Nasdaq: NURO), www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, reported today that WellMed Medical Management, a San Antonio, Texas-based diversified healthcare company and healthcare provider, is integrating the NC-stat DPNCheck into their patient evaluation program.

Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview of the Company at the Bank of America Merrill Lynch 2012 Health Care Conference on Tuesday, May 15th, 2012 at 8:40 a.m. PT.

Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced financial results for the quarter ended March 31, 2012.

Perrigo Company (Nasdaq: PRGO;TASE) today announced that Perrigo Executive Vice President and Chief Financial Officer, Judy L. Brown, will present at the Bank of America Merrill Lynch Healthcare Conference on Tuesday, May 15, at 10:00 AM (PDT) in Las Vegas, NV.

Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and the "Company") today announced that the Company will host a teleconference to discuss its First Quarter 2012 financial results and to provide a business update.

Rite Aid Corporation (NYSE: RAD) announced today that it has closed its previously announced offering of an additional $421.0 million aggregate principal amount of 9.25% Senior Notes due 2020 (the “New Notes”).

Senesco Technologies, Inc. (NYSE Amex: SNT) today reported financial results for the third quarter of fiscal year 2012 which ended on March 31, 2012.

Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF) ("Stellar" or "the Company"), an emerging specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada, today announced financial results for the period ended March 31, 2012.

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark Approval and launch of its EnligHTN™ renal denervation system during EuroPCR.

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that data from the FAME II trial demonstrated a significant difference in the need for urgent revascularization when Fractional Flow Reserve (FFR)-guided assessment was used to direct treatment in patients with stable coronary artery disease.

Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF) announced today results for the three months ended March 31, 2012.

Unilens Vision Inc. (OTCBB: UVIC) (OTCQB: UVIC) (TSX VENTURE: UVI), which develops, licenses, manufactures, distributes and markets specialty contact lenses, today reported its operating results for the third quarter and first nine months of FY2012.

UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce that Cardis Furniture (www.cardis.com) has chosen the Company's Viratech UV-400 as the air purifier to be combined with a premium Serta Mattress as the Ultimate Sleep System for promoting a sound sleep.

Approximately one in four U.S. adults lacks adequate prescription drug coverage1, and with both cost savings and access to health care top of mind for many Americans, Walgreens (NYSE, NASDAQ: WAG) has introduced a new and improved Prescription Savings Club program - providing members greater value and covering a more comprehensive range of medications than any similar offering by any major drugstore chain in the marketplace today.

Analyst says Incyte's pipeline makes it attractive takeover candidate

Tue, 15 May 2012 14:14:00 -0400

Goldman Sachs upgrades Incyte (NASDAQ: INCY) from Neutral to Buy with a price target of $29 (up from $21), suggesting a 26% premium from today's prices as the drug discovery company focused on developing proprietary small molecule drugs becomes the latest M&A target.

Incyte Genomics, Inc.

22.89 -0.13 (-0.56%)

Those who follow Incyte Corporation, know that the company has a broad range of discovery capabilities in-house, including target validation, high-throughput screening, medicinal chemistry, computational chemistry, and pharmacological and ADME (absorption, distribution, metabolism and excretion) assessment. Its products include: INCB18424 (oral) for Prostate Cancer (Metastatic Prostate Cancer), Hematological Malignancies (Primary Myelofibrosis), Psoriasis and multiple myeloma; INCB28050 (oral) for Rheumatoid arthritis and Cancer; INCB13739 and INCB19602 for Type II Diabetes; INCB7839 for Breast cancer and Solid Tumors; INCB28060 and INCB24360 for Solid Cancers; and INCB8696 for Lupus Nephritis.

Pfizer (NYSE: PFE) looks like it is getting its next blockbuster approved after an advisory panel voted 8-2 recommending approval of its rheumatoid arthritis drug tofacitinib and Goldman is reportedly more bullish about INCY due to the significant derisking of Incyte's key pipeline asset LY3009104. In addition, INCY has seen a strong launch of Jakafi-- an indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis and post–essential thrombocythemia myelofibrosis.

"104's potential was validated with the positive FDA panel vote this past week on Pfizer’s tofacitinib," the firm said.Goldman also sees Incyte as a more attractive M&A target given it has a marketed drug and a potential blockbuster pipeline asset.

Shares could be worth up to $37 in a takeover, Goldman Sachs estimates.

We note that this stock is highly shorted and share purchases by insiders have been on the rise.

The BioMedReports FDA Calendar shows a few upcoming milestones for the company over the next two years including news that a randomized Phase II trial of ruxolitinib in combination with capecitabine for patients with recurrent or treatment refractory metastatic pancreatic cancer (the RECAP trial) is expected to enroll approximately 130 patients by the end of 2012. Results from the RESPONSE trial are expected in the second half of 2013.

Pozen's Cermak breaks-down licensing deal for firm's Migrane drug

Mon, 14 May 2012 13:02:00 -0400

In an exclusive interview with Liz Cermak, Executive Vice President and Chief Commercial Officer of POZN, we discuss the implications of a European licensing deal for their migrane drug MT 400.

7.26 -0.02 (-0.27%)

Last week, POZEN Inc. (NASDAQ: POZN) announced a licensing deal with Germany’s CNS focused Desitin Arzneimittel GmbH for the development and commercialization of MT 400 for the European Union as well as Switzerland and Norway. MT 400 is POZEN’s proprietary combination of sumatriptan and naproxen sodium, the first multiple mechanism triptan therapy for the treatment of migraine.

Q: What do investors need to know about this news? How does this deal change your financial forecast, if at all?

Liz Cermak, VP, POZEN Inc.: “Our investors should know that we continue to leverage our products in the best partnership deals possible to create increased shareholder value. Desitin will make an initial upfront payment to POZEN, followed by milestone payments related to the development and launch of MT 400 in certain specified countries. The pre-commercialization payments will total $3.0 million, $0.5 million of which is due on signing. Desitin also will pay POZEN a double digit royalty on net sales of MT 400 that increases based on annual sales volume. The European regulatory approval of this product also will facilitate licenses and approvals with other partners in other territories.”

Q: How does POZEN plan to utilize the revenue from this deal?

Cermak: “As with the milestone and royalty payments received under past agreements, the revenue from this deal will be used to continue to advance the POZEN pipeline, so that we can bring products to market that are affordable to patients and physicians alike.”

Q:Why did you select Desitin as your partner for the development and commercialization of MT 400 in these countries?

Cermak: “Desitin has a strong European presence and history of success in marketing CNS products. We believe Desitin will be an outstanding partner in bringing this novel migraine product to the millions of migraine patients living in Europe.”

Q: How is your partnership with Cilag GmbH International, a division of Johnson & Johnson, for MT 400 in Brazil, Colombia, Ecuador and Peru going?

Cermak: “It is going well. Cilag continues to move forward with their manufacturing set-up and regulatory advice and approval process.”

Q: Are you looking for other partners for MT 400 in any additional countries and if so, where?

Cermak: “POZEN is actively seeking other licensing partners for the additional available territories outside of the U.S. to develop and market sumatriptan and naproxen combinations at other doses. Also, as you know, we are also seeking strong commercial licensing partners for our PA portfolio.”

Q: Are there any milestones or catalysts that investors should be paying attention to going forward for the rest of 2012?

Cermak: “We continue to progress our PA32540 program and New Drug Administration (NDA) submission. At a recent pre-NDA meeting, the U.S. Food and Drug Administration suggested that we also seek approval of a lower dose formulation containing 81 mg of aspirin. We are currently evaluating the best way to do that. However, a major milestone for us this year would be securing a partner or partners for one or more of our PA assets, which we anticipate doing by year-end.”

The company reminds investors that Migraine afflicts between 10-12 percent of people, of which roughly three out of four migraine sufferers are women. Migraine attacks can last from 4 hours to 72 hours and are typically characterized by sharp pulsating pain on one side of the head, nausea, and extreme sensitivity to light and sound. While the precise mechanism of migraine is unknown, researchers believe migraine attacks are caused by acute inflammation surrounding selected vessels in the head. The average migraine sufferer experiences the first attack during the early teen years, and the attacks generally continue throughout adulthood.

Shares of the company have been rebounding since slumping 19 percent in late April-- the most since 2008-- after the Food and Drug Administration threw a cruveball and suggested that POZN seek approval for a lower dose formulation for its PA32540 product.

Disclosure: None

Arena Wins FDA Advisory Panel Backing for Obesity Pill

Fri, 11 May 2012 14:25:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on May 10, 2012.

Advisers to government health regulators late Thursday recommended that they approve sales of what would be the first new prescription weight-loss drug in the U.S. in more than a decade, despite concerns over cardiac risks.

Shares of the drug's creator, Arena Pharmaceuticals, Inc. (NASDAQ: ARNA), nearly doubled, jumping from $3.66 to $7.15 in after-hours trading after trading was temporarily halted.

A panel of expert advisers to the Food and Drug Administration voted 18-4 to recommend approval of Arena's lorcaserin, concluded that its benefits "outweigh the potential risks when used long term" in overweight and obese people. One panel member abstained from voting.

In addition, Arena and Eisai Inc. announced the expansion of the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. Lorcaserin is an investigational drug candidate intended for weight management.

In addition to the United States, the territories in the expanded agreement now include most of North and South America, including Canada, Mexico and Brazil. This expansion builds on the agreement executed by Eisai and Arena in July 2010 for Eisai's exclusive rights to market and distribute lorcaserin in the United States, subject to lorcaserin's approval by the US FDA.

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PolyMedix (OTC: PYMX), a biotechnology company focused on developing innovative therapeutic drugs to treat patients with serious acute-care conditions, today announced an update on the development status of its anticoagulant reversing agent, PMX-60056. PolyMedix has stopped enrollment in two clinical trials for PMX-60056: a Phase 2 clinical trial for reversing the anticoagulant activity of unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention procedures, and a Phase 1B/2 clinical trial for reversing the anticoagulant activity of the low molecular weight heparin enoxaparin in healthy volunteers.

Also Thursday:

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that Dr. Leonard Bell, Chief Executive Officer of Alexion Pharmaceuticals, will present at the Bank of America Merrill Lynch 2012 Health Care Conference in Las Vegas at 8:00 a.m. Pacific time (11 a.m. Eastern time) on Thursday, May 17, 2012.

Alkermes plc (NASDAQ: ALKS) will host a conference call at 8:30 a.m. EDT (1:30 p.m. BST) on Thursday, May 17, 2012, to discuss the company’s financial results for its fiscal year ended March 31, 2012.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today final results from its completed Phase I clinical trial with ALN-TTR01, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR).

The Board of Directors of AmerisourceBergen Corporation (NYSE: ABC) today authorized a new $750 million share repurchase program, effective immediately.

Anacor Pharmaceuticals (NASDAQ:ANAC) announced today its financial results for the first quarter ended March 31, 2012.

Antares Pharma, Inc. (NYSE Amex: AIS) today announced that Jack Howarth, Vice President of Corporate Affairs, will present at the 15th Annual Bank of America Merrill Lynch Health Care Conference on Thursday, May 17, 2012 at 12:00 pm PDT.

A.P. Pharma, Inc. (OTCBB:APPA.OB), a specialty pharmaceutical company, today reported financial results for its first quarter ended March 31, 2012 and highlighted recent corporate progress.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will webcast its presentation at the Bank of America Merrill Lynch 2012 Health Care Conference in Las Vegas. Harvey J. Berger, M.D., chairman and chief executive officer, will provide an overview of the Company’s business on Wednesday, May 16, 2012 at 9:20 a.m. (PT).

CEL-SCI Corporation (NYSE AMEX: CVM) announced today financial results for the fiscal quarter ended March 31, 2012.

Codexis, Inc. (NASDAQ: CDXS), a developer of cost-advantaged processes for the production of biofuels, bio-based chemicals, and pharmaceutical intermediates, today announced financial results for the first quarter ended March 31, 2012.

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today reported financial results for the three months ended March 31, 2012, and provided a business update.

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it will hold its Annual Meeting of Stockholders on Thursday, May 17, 2012 beginning at 9:00 AM Eastern at the InterContinental Harbor Court, 550 Light Street, Baltimore, Maryland 21202.

Exelixis, Inc. (NASDAQ:EXEL) announced today that Michael M. Morrissey, Ph.D., the company’s president and chief executive officer, will present at the Bank of America Merrill Lynch 2012 Health Care Conference at 3:00 p.m. EDT / noon PDT on Thursday, May 17, 2012, in Las Vegas.

Fluidigm Corporation (NASDAQ:FLDM) today announced its financial results for the first quarter ended March 31, 2012.

GE Healthcare, the healthcare business of GE (NYSE: GE) announced today that it has completed the acquisition of Xcellerex, Inc., a supplier of innovative manufacturing technologies for the fast-growing biopharmaceutical industry.

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will present at the Bank of America Merrill Lynch 2012 Health Care Conference on Wednesday, May 16, at 10:40 a.m. PT.

Interleukin Genetics, Inc. (OTCQB: ILIU) today announced financial and operational results for the first quarter ended March 31, 2012.

International Stem Cell Corporation (OTCBB: ISCO) www.internationalstemcell.com today announced that the Company has developed new technologies to commercialize the use of human parthenogenetic stem cells (hpSC) to treat human diseases.

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced that James Scibetta, chief financial officer of Pacira Pharmaceuticals, is scheduled to present at the Bank of America Merrill Lynch 2012 Health Care Conference on Thursday, May 17, 2012, at 10:40 a.m. PT at The Encore at Wynn in Las Vegas.

PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that Michael J. Culotta, Executive Vice President and Chief Financial Officer, will make a presentation regarding the Company at the 11TH Annual JMP Securities Research Conference in San Francisco, California, on Monday, May 14, 2012, at 9:00 a.m. Pacific Time.

Response Genetics Inc. (Nasdaq:RGDX), (the “Company”), a company focused on the development and sale of molecular diagnostic tests for cancer, today announced its consolidated financial results for the first quarter ended March 31, 2012.

RXi Pharmaceuticals Corporation (OTCBB: RXII.OB) today announced that Geert Cauwenbergh, Dr. Med. Sc. has been appointed as the Company’s President and Chief Executive Officer.

RXi Pharmaceuticals Corporation (OTCBB: RXII.OB) announced today that the Financial Industry Regulatory Authority, Inc., also known as FINRA, has approved RXi Pharmaceuticals’ common stock for trading under the stock symbol “RXII” on the OTC Bulletin Board. RXi Pharmaceuticals anticipates its stock will be eligible for trading commencing today, May 10, 2012.

SDIX (Nasdaq: SDIX), a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic and food safety applications, today reported financial results for the quarter ended March 31, 2012.

Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that interim results from an investigator-sponsored phase II clinical trial of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the Society for Investigative Dermatology annual meeting being held May 9-12, 2012 in Raleigh, NC.

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company, today reported its financial results for the first quarter ended March 31, 2012.

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) (Spectrum) and Allos Therapeutics, Inc. (NasdaqGS: ALTH) (Allos) today announced that, on May 9, 2012, each had received from the Federal Trade Commission (FTC) a Request for Additional Information and Documentary Material (Second Request) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, applicable to the acquisition of Allos by Spectrum.

Synageva BioPharma Corp. (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, will present at the upcoming Bank of America Merrill Lynch 2012 Health Care Conference being held in Las Vegas, Nevada.

TherapeuticsMD™, Inc. (OTCQB: TXMD), parent company of vitaMedMD®, LLC ("vitaMedMD"), a specialty pharmaceutical company ("TherapeuticsMD" or the "Company"), announced that on May 10, 2012 it launched its third prescription prenatal vitamin, vitaMedMD™ RediChew™ Rx, following the successful launch of vitaMedMD™ One Rx earlier this month and vitaMedMD™ Plus Rx last month. vitaMedMD RediChew Rx is a small, vanilla flavored, chewable prenatal vitamin tablet that dissolves quickly and is taken once daily.

Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system (“CNS”), including fibromyalgia syndrome (“FM”) and post-traumatic stress disorder (“PTSD”), today announced the appointment of Samuel R. Saks, M.D. (age 57) to the Company’s Board of Directors.

Biogen Announces US and EU Authorities Accept Oral BG-12 Marketing Applications; Watson Confirms Lialda Patent Challenge

Thu, 10 May 2012 14:24:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on May 9, 2012.

Biogen Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory authorities have accepted the company's marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS).

The U.S. FDA has accepted Biogen Idec's New Drug Application (NDA) for marketing approval of BG-12 in the United States and granted the company a standard review timeline. In addition, the European Medicines Agency (EMA) has validated Biogen Idec's Marketing Authorisation Application (MAA) for review of BG-12 in the European Union.

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Watson Pharmaceuticals, Inc. (NYSE: WPI) confirmed its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Mesalamine Delayed-release Tablets, 1.2g. Watson's ANDA product is a generic version of Shire Development LLC's Lialda®.

Also Wednesday:

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that management will present a company overview at the 11th Annual JMP Securities Research Conference on Tuesday, May 15 at 2:30 p.m. PT at the Ritz-Carlton in San Francisco.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced the appointment of William K. Heiden as president and chief executive officer, effective May 14, 2012.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the first quarter ended March 31, 2012 and provided an update on corporate developments.

Arrowhead Research Corporation (NASDAQ:ARWR) today announced that David Lewis, Ph.D., Vice President Biology and Site Head of its Madison, WI research and development facility presented data at the European Foundation for Clinical Medicine Conference in Basel, Switzerland. Dr. Lewis’ presentation, “DPC Technology for Safe and Effective siRNA Delivery” described the development and capabilities of Arrowhead’s Dynamic Polyconjugate (DPC) siRNA delivery platform, as well as the system’s deployment in the development of a new treatment for chronic Hepatitis B.

BioClinica®, Inc. (NASDAQ: BIOC), a leading global provider of clinical trial management solutions, today announced its financial results for the first quarter ended March 31, 2012.

Biogen Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory authorities have accepted the company’s marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS).

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today reported its corporate highlights and financial results as of and for the three months ended March 31, 2012.

BioScrip, Inc. (Nasdaq: BIOS) today announced 2012 first quarter financial results. First quarter revenue was $155.6 million and net loss was $2.7 million, or $0.05 per share.

HospiScript Services, a wholly owned subsidiary of Catalyst Health Solutions, Inc., (NASDAQ: CHSI) recently announced that HospiScript has been selected as the exclusive provider of pharmacy benefit management (PBM) services to all of Harden’s home and facility-based hospice patients.

Covidien (NYSE: COV), a leading global provider of healthcare products, will present at the Bank of America Merrill Lynch 2012 Health Care Conference in Las Vegas, NV, on Wednesday, May 16, 2012.

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today reported financial results for the quarter ended March 31, 2012.

Human Genome Sciences, Inc. (Nasdaq: HGSI) today confirmed that GlaxoSmithKline plc (GSK) has announced its intention to commence an unsolicited tender offer to acquire all the outstanding common shares of HGS at a price of $13.00 per share in cash.

MannKind Corporation (Nasdaq: MNKD) today reported financial results for the first quarter ended March 31, 2012.

INC Research, LLC has broadened its services around Medidata Solutions’ (NASDAQ: MDSO) clinical cloud platform by attaining three new accreditations.

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today reported that its wholly owned subsidiary, Medgenics Medical Israel Ltd. (MMI) was awarded a government grant of up to NIS 8.1 million (approximately USD 2.2 million), net, from the Office of the Chief Scientist (“OCS”) at the Ministry of Industry, Trade and Labor of Israel.
NeuroMetrix, Inc. (Nasdaq: NURO) www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, reported today that it will be an exhibitor and sponsor at the 14th Malvern Diabetic Foot Conference on May 9-11, 2012 in Malvern, United Kingdom, at the Abbey Hotel.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB), a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its Phase 3 clinical studies investigating Lymphoseek® (Kit for the Preparation of Technetium Tc 99m Tilmanocept for Injection) in head and neck cancer, breast cancer, and melanoma and from Phase 1/Phase 2 clinical trials of its Alzheimer’s Disease candidate, AZD4694, were accepted for presentation at several upcoming scientific and medical meetings in May.

Neutra Corp. (OTCBB:NTRR), an emerging nutraceuticals provider, announced today that it has begun formulating its next groundbreaking product: an all-natural supplement designed to restore the body’s natural pH balance.

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced consolidated financial results for the quarter ended March 31, 2012 and reviewed recent accomplishments, including the commercial launch in the United States of EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical pain and the successful completion of an equity financing.

Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced that Cooper Collins, President and Chief Executive Officer, will present at the Bank of America Merrill Lynch 2012 Health Care Conference on Thursday, May 17, 2012 at 11:20 a.m. PDT.

Pfizer Inc. (NYSE:PFE) announced today that the Arthritis Advisory Committee to the U.S. Food and Drug Administration (FDA) voted 8-2 to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announces that Phase 2 final data on PV-10 for metastatic melanoma will be presented at the 2nd European PostASCO Melanoma Meeting 2012, Interdisciplinary Global Conference on Developing New Treatments for Melanoma, on June 22, 2012, in Munich, Germany.

Puma Biotechnology, Inc. (OTCBB: PBYI), a development stage biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will present an overview of the Company at 3:00 p.m. PDT on Wednesday, May 16, at the Bank of America Merrill Lynch 2012 Health Care Conference.

Sucampo Pharmaceuticals, Inc. (“Sucampo” or the “Company”), (NASDAQ: SCMP), a global pharmaceutical company, today reported its consolidated financial results for the first quarter ended March 31, 2012.

Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, today announced first quarter 2012 financial results for the three month period ended March 31, 2012.

Synageva BioPharma Corp. (“Synageva”) (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, today reported first quarter 2012 financial results, and provided data from a natural history study of infants with early onset LAL Deficiency that were recently presented at the 3rd International Congress for Lysosomal Diseases held in North Cyprus, Turkey.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today issued updated dial-in information regarding the conference call to be held today, May 9, 2012 at 8:30 a.m. ET to discuss its first quarter 2012 results.

As an integral part of its transformation to become America’s first choice for health and daily living, Walgreens (NYSE: WAG)(NASDAQ: WAG) today announced it has selected GSD&M to be its new brand and creative agency of record.

Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases announced that Zalicus management will provide an overview of the Company at two upcoming investor conferences.

GSK launching $2.6 billion tender offer for HGSI

Wed, 09 May 2012 12:39:00 -0400

GlaxoSmithKline is to take its unsolicited $2.6 billion takeover bid for Human Genome Sciences direct to shareholders in the U.S. biotech group by launching a tender offer at $13 a share this week.

Human Genome Sciences, Inc.

14.49 -0.13 (-0.89%)

GlaxoSmithKline PLC ADS

45.46 -1.11 (-2.38%)

As you may recall, HGSI rejected the approach from Britain's biggest drugmaker last month, saying it did not reflect the company's inherent value, but GSK insists its bid is "full and fair".

The U.S. pioneer of gene-based drug discovery sells with GSK a new drug for lupus, called Benlysta, and the companies are also collaborating on two other drugs for diabetes and heart disease that could become significant sellers. Buying Human Genome would give GSK full rights to these partnered drugs. A spokeswoman for GSK declined to say exactly when this week the tender would be launched.

The tender will remain open for 20 business days after its commencement. Human Genome has hired Goldman Sachs and Credit Suisse to explore strategic alternatives, including a possible sale of the company, and has invited GSK to join the process.

GlaxoSmithKline, which has profit-sharing agreements with HGS on three drugs, said Wednesday that its offer was 81 percent more than the HGS share price on April 18, before HGS disclosed the earlier private offer.

The tender offer, which is a direct approach to the target's shareholders, will remain open for 20 days.

Glaxo said it remains "willing to meet and review its offer with HGS at any time," but said it believes Human Genome has had ample time to complete its review of alternatives. Glaxo also said its participation in the review process is unnecessary as it isn't "conditioned on due diligence or financing and can be completed expeditiously."

Human Genome Sciences has developed core competencies in the discovery and understanding of human genes and their biological functions, and in the discovery and development of novel therapeutic agents. Its albumin-fusion technology allows the company to create long-acting forms of protein drugs by fusing the gene that expresses human albumin to the gene that expresses a therapeutically active protein. The company has developed compounds in clinical development which includes drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS.

Human Genome Sciences' products include: BENLYSTA®, an investigational human monoclonal antibody drug that specifically inhibits the biological activity of B-lymphocyte stimulator; Raxibacumab, a human monoclonal antibody drug that is developed for the treatment of inhalation anthrax; Mapatumumab (HGS-ETR1), a human monoclonal antibody that induces cancer-cell death in a highly targeted way by activating the protein known as TRAIL receptor 1; Syncria® (albiglutide), a biological product that designed to act throughout the body to help maintain normal blood-sugar levels and to control appetite; Darapladib for coronary heart disease and ischemic stroke; etc.

The BioMedReports FDA Calendar shows seven upcoming milestones for HGSI, several of them related to late stage clinical trials. In March, GlaxoSmithKline plc announced that topline results had been received from seven of the eight ‘Harmony’ Phase III studies investigating the use of Albiglutide in type II diabetes. Albiglutide is an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist. Albiglutide Harmony 8 will complete in mid 2012 and the five ongoing studies will complete in early 2013. The Harmony programme was designed to permit assessment of safety and durability of glycemic control after long-term use. The studies will provide data on the effect of albiglutide over three years, the first GLP-1 agonist to do so.

Of Price Targets and Buyout Rumors for OMPI

Tue, 08 May 2012 13:42:00 -0400

After recently announcing that their Q1 2012 sales rose 16% to a record $30.8 million and notching the highest sales quarter in their firm's history, this specialty pharmaceutical company that develops, markets and sells proprietary skin care systems is rumored to be getting attention from some of the leading consumer cosmetic firms in the world.

Obagi Medical Products, Inc.

12.52 +0.26 (+2.12%)

In early March, we first told our readers about possible buyout offer developments for Obagi Medical Products, Inc. (NASDAQ:OMPI). Shares were trading around the $11 mark at the time and have been trading higher since.

Shortly after our initial report on, we told readers that Cantor Fitzgerald had increased its price target on Obagi to $14 after the company reported stronger than expected Q4 results. The stock ran to a 52-week high of 13.75 and now trades -10.91 % below that mark.

Within the last few days, the Cantor analysts put out another note to his firm's clients stating that management "was evasive on the call about solicitations of interest from potential acquirers" but that offline the company's management team indicated that "it cannot comment on discussions with suitors and will only make an announcement if a deal is underway." Cantor noted that the most recent dermatology acquisition of privately held Fougera was at a 3.55x multiple of sales, which, if applied to Obagi, would value the company at $23/share.

Almost simultaneously, Roth Capital just raised Obagi Medical Products' price target to $16 and Canaccord Genuity maintained a 'Buy' on the company with their price target lowered from $22.50 to $21.00.

Clearly, we also continue to hear offer rumors from reputable sources. As we understand it, the firm is and has been weighing several buy-out offers and one major cosmetics space player may be prepared to offer $20+ per share of the company. There are no guarantees that OMPI will take the offer, of course, but it is obvious that someone thinks this is a business worth snatching at a nice premium.

Shares of Obagi Medical Products traded down 4.82% on their good news last Friday, hitting $12.23. OMPI shares have a 52-week low of $8.61 and a 52-week high of $13.75. The company has a market cap of $228.6 million and a price-to-earnings ratio of 23.80.

Obagi Medical Products sells topical aesthetic and therapeutic prescription-strength skin care systems in the physician-dispensed market. As far as risk is concerned here, we point to a March note to investors from Cantor Fitzgerald in which they said the firm had two important positive developments: (1) Obagi had resolved its TX dispute and could reinstate HQ sales in the state. They expected a gradual ramp as TX physicians work down existing arbutin (non-HQ) inventories and begin stocking HQ products. Second, the company expects to launch its e-pharmacy in 3Q:12, and management believes that the initiative will result in a 5-year CAGR of 15-20%.

"Management believes that it can recoup its ~$11M initial investment within 12 months and thinks that the site will require approximately $2-3M in incremental costs to the business, which is viewed as a low-risk investment," wrote Cantor's analyst.

On the flip side, Elliot Wilbur of Needham & Company recenty wrote that, "OMPI kicked off its 2012 financials with the largest positive revenue surprise vs. consensus in over two years, even more impressive considering the company derived essentially no benefit from new physician account additions and only a modest contribution from new product introductions in the period. Despite the strong start, management stuck to its guns, reiterating prior year revenue guidance though with resumption of shipments into the Texas market (~8% of historical sales) just yesterday, we suspect top-line trends will at least track toward the higher end of current guidance range."

For now, Needham maintains a 'Hold' on Obagi.

Here is a look at the score card for Obagi Medical Products' analysts:

Disclosure: None

Herbalife's Sudden Weight Loss May Present Opportunity

Mon, 07 May 2012 14:06:00 -0400

Shares of Herbalife Ltd.(HLF) began showing life on Friday after brutal week of selling. Is it this now the amazing buying opportunity one activist analyst says it is?

46.99 +0.05 (+0.11%)

Herbalife had announced and now disclosed through and 8K filing that the firm has entered into an agreement with Merrill Lynch International to repurchase $427.9 million of Herbalife's common shares as part of the Company's previously announced share repurchase program. Shares that are repurchased will be retired.

Under the terms of the repurchase agreement, Herbalife will pay $427.9 million on May 4, 2012 from the Company's cash on hand and from borrowings under the Company's senior secured revolving credit facility. The transaction is expected to be completed by no later than July 2012.

Earlier in the week shares of the company had imploded following some very steady growth since the start of the year. Investors sold off stock in the nutrition and weight loss company following a series of questions from short-seller David Einhorn during a conference call regarding why the company did not disclose its breakdown of different kinds of distributors in its last regulatory filing.

Apparently, Herbalife had stopped disclosing how many of its salespeople solely make their money from a recruitment model similar to the one used by Avon in which "salespeople" can also make money recruiting others to sell Herbalife products. This was something the company traditionally told investors, but during the conference call, the company's CEO responded that he and the other executives didn't think it was a valuable metric.

Interestingly, after the call, the company disclosed on its website that its percentage of salespeople who were recruiters had dropped to 12%. That number was in the 20s a few years ago according to CNN Money. Skeptical investors began to jump ship and just when speculators who kept buying shares all the way down thought the bleeding was done, things seemed to only get worse one day after another. By Thursday evening, shares had lost nearly 25% of their value.

For the past five quarters, the company has seen double-digit year-over-year percentage revenue growth and analysts do see a more positive outlook about the company's expected financial results, so this could be a set-up for a good trade-- particularly if shares move past levels of a key resistance in the $51 range.

The stock buy-back should help do what it is designed to do: Spur more buying at these levels. In addition, given the hunger for "weight-loss stocks" seen in the market these days, some of the traction lost during the past few days may also help the stock catch on with speculators who may see this as good bottom bounce buying opportunity. Put this on your watchlist to see how shares react.

Given the hunger for "weight-loss stocks" seen in the market these days, some of the traction lost during the past few days may also help the stock catch on with speculators who may see this as good bottom bounce buying opportunity Herbalife was founded in February 1980 by Mark Hughes with a mission to change people's lives by providing "the best business opportunity in direct selling and the best nutrition and weight management products in the world."

While we do not see any upcoming catalysts or milestones on our FDA catalyst calendar, the firm is currently engaged in conducting clinical studies to investigate different aspects of nutrition.

Those clinical studies include: 1) a controlled trial of protein enrichment of meal replacements for weight reduction and retention of lean body mass; 2) increased protein intake using protein-enriched meal replacements compared to conventional protein intake and meal replacements in overweight subjects; 3) efficacy of low-calorie, partial meal replacement diet plans on weight and abdominal fat in obese subjects with metabolic syndrome: a double-blind, randomized controlled trial of two diet plans - one high in protein and one nutritionally balanced; and 4) arginine and antioxidant supplement on performance in elderly male cyclists: a randomized controlled trial.

One analyst thinks the stock has become a screaming buy. In a research note published after the conference call, Timothy Ramey, an analyst at D.A. Davidson, said the selloff in Herbalife shares has created “a major buying opportunity.” If his screams are based on valuation, he might have a point. We're watch listing and watching the trading closely.

Novavax and the New Paradigm

Fri, 04 May 2012 15:24:00 -0400

Novavax: the name is notorious even among biotechs. It has provided traders with a roller-coaster ride, ranging in twelve years between $0.71 and $14. It is now trading toward the low end of a chart that looks like the jagged peaks of the Himalayas.
Against this background, the recent spate of insider buying is intriguing. In mid-April, when shares were trading at just under $1.20, we called attention some of that buying and while shares have been rising since, our article that was-- to say the least-- incomplete. There has been plenty of speculation and we've started to see enough buying that the downward technical trend appears to not only be broken, but shares are now trading above the fifty day moving average.

Now, if you're interested at all, you may want to download this poster presentatio n. Don’t scratch your head over it; we’ll get to it later and tie in why it is likely related to that insider buying.

Novavax has been around since 1987. In the early days, the name implied one thing, while the company’s actual products involved estrogen supplementation. But someone in the early days must have had a hot idea, literally. The story begins, unbelievably, in Yellowstone National Park, near the Great Fountain Geyers, where Thomas D. Brock and Hudson Freeze discovered a strange bacterium that lives in superheated water. The little bug makes Taq, the indispensable enzyme. Without Taq, I wouldn’t be writing this story. But thankfully, Cetus developed Taq, and sold it to Hofmann LaRoche for $330M. Taq makes it possible to replicate DNA with a machine that fits on a tabletop; as much as you want, when you want. Taq made it possible to conceive of tinkering with life as never before; in fact, making life itself. But the Novavax goal was more modest: use this ability to easily manufacture DNA to make new vaccines, faster, more pure, and more effective than existing methods could provide.

The skepticism that a little company like Novavax could produce a new flu vaccine has abated since the spectacular Mexico trials and the BARDA contract, but since flu has been the visible driver since about 2004, it’s worth a look. The first vaccines were made with the use of whole, live animals, which were sacrificed, but flu vaccines have traditionally been made using eggs.

DNA is not a vaccine; it is a blueprint for structures of living things. To make a vaccine, we need a biochemical machine, a living cell that can be hijacked, and repurposed to make the essential ingredients of a vaccine. The first vaccines, in the 19th century, involved sacrifice of live animals. The traditional flu virus “factory” has been the chicken egg. The initial season of H1N1 in the U.S. required about 100 million eggs, each inoculated between the ninth and twelfth day after laying. Not to mention all those roosters who are kept very busy doing their thing with the hens.

This is the way it’s supposed to work. After six months, and billions of eggs worldwide, the vaccination campaign begins. But with H1N1, the eggs produced only 30% as much virus as normal. The virus was killing the eggs, quickly. Even when the yield is good, the length of time required to make the flu jab has interfered with a good night’s sleep at CDC and NIH for years. And here’s why. The 1918 flu was so severe that a young, healthy man would get sick in the morning, and die in the afternoon, drowned in his own fluids. It could happen again. It can happen again, at any time, because flu is a fragile RNA virus that is constantly changing and recombining with other strains. This is why every season, the flu is different, and this is why catastrophe lurks in every roll of the RNA dice.

With the estrogen patch biz up front, Robin E. Robinson, who came onboard Novavax in 1992, worked in the back room with colleagues developing IP for potential vaccines, against diseases like malaria, human papilloma, hepatitis, prostate, melanoma, and cervical cancers and, of course, the flu. Not ready for the clinic, these have been tested “in the dish”, or in animals.

Lack of focus? No! Instead of a single do-or-die blockbuster drug, the goal was A New Way of Making Vaccines. Close book on eggs. Novavax is about a New Paradigm. Of course, a new paradigm could also create a blockbuster. Is the insider buying related to this? Yeah. Hold your horses. We’ll get to it. This is the New Paradigm:

1. Obtain a sample of the virus.

2. Extract the DNA or the RNA, and make a large amount of DNA by PCR, using the marvelous Taq that came from Yellowstone’s geysers. This can be done on a tabletop.

3. Clean your lab and get rid of the nasty live virus. It’s not needed anymore. As we shall see, this is a big advantage.

4. Using chemical scissors called restriction enzymes (valuable IP of Novavax), cut up the DNA to get the desired pieces. Candidates are any parts of the outer shell of the virus that might be used to immunize a person.

5. Purify the cut-up pieces you want. Left behind is the interior viral machinery that infects and destroys human cells.

6. The desired pieces of DNA are just a blueprint. A biological machine, some kind of living cell, is required to manufacture from the blueprint. Caterpillar cells work really well. Complete cookbook systems, like Invitrogen’s Bac-to-Bac®, make cloning an easy, 5 minute procedure. Check it out.

7. Caterpillar cells make so much of the desired “stuff”, so fast, that it takes only three months to complete a manufacturing cycle. And there’s no waiting for hens to lay their eggs. A lot of roosters are going to get laid off…or worse.

From this point on, the New Paradigm is incredibly safe. Insect viruses infect only insects. The target virus is represented only as a genetic code. But making a vaccine is still a challenge. A traditional vaccine factory looks like a brewery, and it is very hard to get something that big absolutely sterile. This is a problem with both eggs and with cell cultures, which are grown in large bioreactors. Possible examples are the 1976 swine flu campaign, the 2004 Wyeth flu vaccine, and Baxter’s Preflucel recall in 10/11.

Go into a modern biotech lab, and you’ll see that practically every container, for both liquids and cultures is made of plastic, and disposable. While microbes can be killed with heat, DNA is very, very tough. To clean all the DNA out of a cell culture factory takes lots of very toxic, hard to handle chemicals, and it doesn’t always work. So Novavax invented the Disposable Vaccine Factory. Every time the factory gears up for another run, the bioreactors are thrown out, and replaced with new. Because they are presterile, and have never been exposed to DNA, the chances of contamination are very much reduced. Because the parts and cultures are replaceable at reasonable cost, there is no need to sell the company, which is what Wyeth was faced with in 2004. The startup costs are less, too; Novavax claims only 40% that of a traditional plant.

Does the Novavax “New Paradigm” make it sound too easy? Maybe.

Nuveen California Dividend Advantage Municipal Fund 2

15.36 - (0.00%)

Would accelerated FDA approvals attract more investors?

Thu, 03 May 2012 15:28:00 -0400

Congress appears poised this year to deliver on years of lobbying by industry to speed up reviews of new drugs and cut regulatory red tape.

That helping hand alone, however, isn’t likely enough to draw investors, still shell-shocked by the recession, back into funding new biopharma startups and early-stage companies.

Several bills promising fast relief for biopharma are pending in Congress. Chief among them is the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Faster action on drug applications is the goal of the Faster Access to Specialized Treatments (FAST) Act introduced in the House of Representatives; the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act introduced in the Senate; and another Senate bill, the Advancing Breakthrough Therapies for Patients Act of 2012.

Among the claims made in support of the measures is that they will help draw venture capitalists and other traditional investors back to biopharma companies, thawing the long-chilly investment climate knocked cold by the Great Recession and weak recovery of the past five years. Maybe so, but it won’t likely be as quickly as startups are hoping for.

Read the Rest of this Report

Will Coronado's Data Help Sell Wall Street and Big Pharma?

Wed, 02 May 2012 14:42:00 -0400

Earlier this week, Coronado Biosciences, Inc. (NASDAQ: CNDO) announced that Phase 1 TSO Data will be presented as an oral presentation at the 8th International Congress on Autoimmunity to be held May 9-13, 2012 in Granada, Spain. Why should investors care?

If you don't yet know what this biopharmaceutical company is up to and why this is one of the most intriguing biotech plays in healthcare, then chances are you haven't heard about TSO (Trichuris suis ova or CNDO-201). This treatment is made up of microscopic eggs of the porcine whipworm and while you may not yet understand it, there is more and more evidence that this novel, orally administered, natural immunomodulator regulates T-Cells and pro-inflammatory cytokines.

6.41 -0.09 (-1.38%)

As you will see in my interview with CEO Bobby W. Sandage, Jr., Ph.D., the use of porcine whipworm eggs as a promising therapeutic agent is based on the "hygiene hypothesis" and numerous animal and human studies which presented truly compelling data.

"It’s an intestinal worm," explains Sandage. "It’s an intestinal parasitic worm and the one that we used that was invented at the University of Iowa by these three doctors we call it TSO. It’s short for Trichuris ova and it’s the pig whipworm eggs if you will. TSO, Trichuris was selected by the inventors at the University of Iowa because it had a number of features that were beneficial to human exposure. One, when you take it, it causes the immunological immuno-modulating response that you want but it doesn’t cause any permanent infection and they simply die in a couple of weeks and are eliminated from the body. You have to take it every two weeks to continue to get the effect. It has some other features. It never leaves the GI tract, doesn’t get in the bloodstream. There’s no way to infect another person with it and it turns out the ova or the eggs are very stable and I can put it through what it needs to do to become a pharmaceutical grade dosing unit." The management team and early investors behind Coronado Biosciences chose TSO as the biological agent precisely because it is not a human pathogen, and is spontaneously eliminated from the body just weeks after dosing. What these organisms appears to do while they are in the human body, however, is what is causing the medical community to take a long, hard look at the implications presented by this discovery for many, many autoimmune diseases.

"We have four studies completed," says Sandage."The first one was done in 29 patients with Crohn’s disease where we were able to demonstrate that over 72% of the patients had clinical remission at the end of 24 weeks of treatment and almost 80% had a clinical response. We also have a double-blind, placebo-controlled trial in ulcerative colitis patients in where the placebo rate was about a 17% response whereas the TSO group had a 43% response, more than doubling the response rate in the patients with ulcerative colitis. Then we have an initial trial in multiple sclerosis where the investigator at the University of Wisconsin showed a 70% reduction in what’s known as a gadolinium-enhanced MRI lesion so a surrogate of the disease of the neurons found in multiple sclerosis patients. When he stopped the treatment it went right back up to having diseased neurons.The fourth study is a study we just finished in which it was called a single-dose dose escalation. We went up to very high doses, more eggs, up to 7500 eggs and it was extremely well tolerated with only mild GI side effects being seen in just a few people that were self-limiting and didn’t even require any treatment."
Despite attempting to run and stay higher, the big-board listed stock continues to find it's way back to the $6.50-$7.00 range. As investors have begun to discover the emerging biotech company, new speculators appear captivated by the science and Coronado's story, but it may take the type of data seen in earlier studies to really sell Wall Street into buying and keeping Coronado shares. I would not bet against that scenario or the senior managers, board of directors and the scientific advisory board. The list here reads like an impressive who's who and this is a company built not only for the race, but to get across the finish line.

In addition, Dr. Lindsay A. Rosenwald, M.D.- who among other things, helped shape and sell Cougar Biotech for $1 billion in cash to Johnson&Johnson in record time back in 2009-- is placing a big bet on CNDO; telling me candidly about his hopes for Coronado; one of his "all-time favorites."

The BioMedReports FDA Calendar shows several milestones for the company, including some key data reveals this year. I invite our readers to become familiar with CEO Bobby Sandage and Coronado Biosciences by paying close attention to our exclusive interview. Keep CNDO on your watchlist they could be on to something big with these porcine whipworm eggs. Really.

Astex focused on creating value for investors in 2012

Fri, 27 Apr 2012 14:17:00 -0400

Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), the pharmaceutical company dedicated to discovering and devloping novel small molecule therapeutics, just announced that it will release its 2012 first quarter financial results on Monday, April 30, 2012. While its not known if the company will surprise the market with any ground moving developments by then, James S.J. Manuso, PhD, chairman and chief executive officer of the firm says that his company has an opportunity to "surprise investors with significant value creation" going forward in 2012.

1.71 +0.01 (+0.59%)

While Manuso and the Astex Pharmaceuticals management team will provide details of the Company's financial results and any revised outlook for the future we do know that it has been over 7 years since the firm raised money in the markets and that for 2012 financial performance, they were guiding to the achievement of approximate cash flow neutrality.

In February, Astex shares got hammered after regulators turned a skeptical eye on a leukemia-related drug the company licensed to Eisai. More recently, the pharmaceutical company presented data on their novel, first-in-class, direct acting antiviral agent (DAA) against Hepatitis C Virus (HCV) at the 47th Annual Meeting of the European Association for the Study of the Liver (EASL): The International Liver Congress™, April 18 to 22, 2012 in Barcelona, Spain. Although technical, the posters below showcase the strength of Astex’s Pyramid™ technology to deliver promising new pipeline assets and highlight Astex’s move into a new therapeutic area.

Poster 19057 [here in pdf form] explains the selection process of the preclinical candidates using Astex’s industry-leading Pyramid fragment screening technology. The results are the identity of a new druggable binding site (clinically proven) on the serine protease of the Hep C virus, NS3, and the discovery of the two novel compounds.

Poster 19064 [here in pdf form] follows on from the previous poster, explaining the development process of the two compounds into preclinical candidates and their optimisation with respect to human pharmacokinetics and improved potency. Key features of the design of these two compounds is the potential for once daily oral dosing and for their use in polytherapy regimes required for effective HCV treatment.

Given how hot stocks in the Hepatitis C Virus space have been on Wall Street, we reached out and asked CEO Manuso to walk us through some key questions about his firm and their platform:

BioMedReports: Astex are focused mainly on oncology and have a successful myelodysplastic syndrome (MDS) product in Dacogen™(decitabine). What prompted this work into virology and specifically HCV?

James S.J. Manuso, PhD: The Pyramid™ discovery platform is agnostic to indications and has been successfully used against targets from many therapeutic areas in partnerships with big pharma. HCV was targeted given the need for new anti-virals with novel mechanisms of action.

BioMedReports: Could you describe the benefits of your fragment-based Pyramid™ system and why it is suited to the development of the compound?

James S.J. Manuso, PhD: Our discovery methodology allows us to find drugs against different target binding sites, such as allosteric pockets, compared with traditional high-throughput screening.

BioMedReports: What is it about AT26893 that distinguishes it from other direct acting antiviral agents (DAA) currently on the market or in development?

James S.J. Manuso, PhD: Unlike other DAAs AT26893 targets a novel binding site between the protease and helicase domains, and represents the first allosteric, non-competitive inhibitor of the NS3 protein which may confer a complementary clinical activity.

BioMedReports: AT26893 is in pre-clinical development now – when do you anticipate starting phase I trials?

James S.J. Manuso, PhD: We have not given guidance on that timeline yet. The current status is preclinical.

BioMedReports: Astex has successfully partnered several of its pipeline assets with a number of companies, including GSK, Novartis, AstraZeneca and Janssen. Are you looking for a partner for this asset?

James S.J. Manuso, PhD: As data develops, we are discussing the possibility of partnering with appropriate companies.

BioMedReports: What are Astex's most important catalysts/milestones investors should be aware of this year?

James S.J. Manuso, PhD: Dacogen EMA review of an AML submission by JNJ and four phase II data read outs in the fourth quarter.

BioMedReports: What are the biggest challenges for the company?

James S.J. Manuso, PhD: Identifying the right biology that will result in addressing the unmet medical need we are targeting.

BioMedReports: What are the biggest opportunities?

James S.J. Manuso, PhD: Surprising investors with significant value creation in 2012.

Anthera Announces Completion of Phase 2b PEARL-SC; AstraZeneca/The Medicines Company Announce Global Collaboration

Thu, 26 Apr 2012 15:00:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 25, 2012.

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) announced the completion of dosing in the Company's Phase 2b PEARL-SC study. PEARL-SC (A randomized, double-blind Phase 2b study to evaluate the efficacy, safety, and tolerability of blisibimod administration in subjects with systemic lupus erythematosus) is examining the therapeutic benefit of monthly and weekly subcutaneous administration of blisibimod in systemic lupus erythematosus (SLE) patients.

The primary endpoint of the PEARL-SC study is clinical improvement at 24 weeks in an SLE responder index (SRI)-- a composite responder index evaluating various patient and physician reported clinical disease activity including a SELENA/SLEDAI* improvement of 5 points or greater, no increase in a physician's global assessment of more than 0.3 points, with no new BILAG A or two or more new BILAG B organ domain scores.

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AstraZeneca (NYSE: AZN) and The Medicines Company (NASDAQ: MDCO) announced a global collaboration for acute ischemic heart disease compounds. The first part of this collaboration is a US co-promotion for AstraZeneca's oral antiplatelet medicine BRILINTA® (ticagrelor) tablets.

Under the terms of the co-promotion agreement, The Medicines Company sales force will begin supporting BRILINTA in May 2012. This will complement the AstraZeneca sales team's promotion of BRILINTA to US hospital customers and practitioners whose patients with acute coronary syndrome (ACS) may benefit from this important therapy.

Also Wednesday:

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today presented data showing that the increase in walking speed demonstrated by people with multiple sclerosis (MS) who responded to treatment with AMPYRA® during three-month Phase 3 clinical trials was also observed for up to five years in open-label extension studies.

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that Dr. John Rothman, EVP of Science & Operations at Advaxis, will be chairing and speaking at the morning session of the 2012 World Immunotherapy Online Symposium Series, produced by Target Meeting, on April 27, 2012 at 9am EST.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will host a live webcast of its quarterly conference call at 8:30 a.m. (ET) on Wednesday, May 9, 2012.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that its first quarter 2012 financial results will be released on Monday, May 7, 2012. BioCryst will host a conference call and webcast at 11:00 a.m. Eastern Time to discuss the financial results and to provide an update on the Company’s programs.

BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that an Issue Notification has been received from the United States Patent and Trademark Office (USPTO) granting 1,787 days of Patent Term Adjustment for the patent claiming the composition of BCM (BL-1040), a novel medical device for prevention of cardiac remodeling following an acute myocardial infarction.

Fortinet (NASDAQ: FTNT), a leader in high-performance network security, and Gilead Sciences, Inc. (NASDAQ: GILD), a leading biopharmaceutical company, received 2012 GROW! Awards from ACG Silicon Valley at a sold-out ceremony with 81 CEOs and over 200 other Valley executives in attendance.

GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced the FDA clearance and availability of the latest version of its Vivid E9™ cardiovascular ultrasound system.

GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast to provide a corporate update and discuss the Company's first quarter 2012 financial results on Tuesday, May 8 at 9:00 a.m. Eastern.

Illumina, Inc. (NASDAQ:ILMN) today introduced BaseSpace Apps, a dedicated applications store for BaseSpace, the Company’s genomics cloud computing platform.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB), a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that Dr. Thomas Tulip, Navidea’s EVP and Chief Business Officer, was invited to present at two Alzheimer’s Disease (AD) conferences: Alzheimer’s Disease Neuroimaging Initiative (ADNI) Private Partner Scientific Board meeting and the German Nuclear Medicine Convention.

Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced that the underwriters of its previously announced public offering of common stock have exercised in full their overallotment option to purchase an additional 900,000 shares of common stock at the public offering price of $9.75 per share, less underwriting discounts and commissions.

Repligen Corporation (NASDAQ:RGEN) today announced positive results from a Phase 1 study to evaluate the pharmacokinetic (PK) and safety profile of RG3039, a novel small molecule drug candidate for the potential treatment of spinal muscular atrophy (SMA).

Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) and Progenics Pharmaceuticals (NASDAQ: PGNX) today announced that the Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency’s review of the Supplemental New Drug Application (sNDA) for RELISTOR® (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.

SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification technologies to the healthcare industry, announced today that it will host a live webcast of its second quarter 2012 conference call on Tuesday, May 8, at 4:00 p.m. CT.

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced a reduction in force as part of a strategic plan to focus the company’s resources on its clinical programs and select preclinical opportunities.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the first quarter ended March 31, 2012.

A Rare, De-Risked Break-Out Stock For Healthcare Investors

Wed, 25 Apr 2012 14:15:00 -0400

Not only are shares of this healthcare sector stock just starting to break-out technically, fundamental indicators are also pointing to higher prices ahead.

Telling the story of Neptune Technologies and Bioresources (NASDAQ: NEPT) can be a complicated and drawn out process. When one first discovers the company, one has to peel back the layers to find that this is truly a rare healthcare play and that each layer is valuable on its own for multiple reasons.

First, Neptune is a well-established leader involved in the development and commercialization of Neptune Krill Oil (NKO®)-- a marine omega-3 phospholipid that exhibits high levels of excellence in omega-3 standards and that may be set to surprise Wall Street with strong revenues generated in part from their rapidly expanding manufacturing capacities and partnerships with major multi-national food and nutraceutical leaders.

NEPT: Investors Presentation

Krill Oil Based Drug Candidate Could Unseat Glaxo's Blockbuster Lovaza

Neptune Technologies & Bioresources, Inc.

3.10 +0.01 (+0.26%)

Second, Neptune has considerable ownership stakes in two intriguing biotech spin-offs seeking to develop and exploit pharmaceutical applications for those Krill-based bioactive ingredients in huge multi-billion dollar markets, each with vast unmet needs. Neptune shareholders have their own stake in the subsidiaries, Acasti Pharma (TSX:APO) and NeuroBioPharm-- each of which aim to demonstrate the therapeutic benefits for human conditions which include: Hyperlipidemia/ Cholesterol Management, Premenstrual Syndrome, Skin Cancer, Attention Deficit and Hyperactivity Disorder (ADHD), and more.

Not only is the Neptune proposition strong enough to consider holding as a core position in one's investment portfolio, but with several pending news and milestone developments, the company is also an attractive play for speculators who are seeking a company with near-term payoffs.

As the story of Neptune begins to spread and take hold, our sense is that you will see an increase in ownership from institutional investors and even more analyst coverage for the company in the days ahead.

Wael Massrieh, VP of Scientific Affairs at Neptune Technologies and Bioresources (NASDAQ: NEPT), discussed with us the reasons why his company is one of the most diverse and nearly de-risked investments in the healthcare sector.

"Going the pharmaceutical route has always been in the mission of Neptune," explains Massrieh. "When Neptune was created that was the long-term goal. We obviously didn’t think that it would be possible at that time to do it right away. So Neptune has created the dietary supplement business of selling Neptune Krill Oil-- as a steppingstone to the big, the homerun, as I like to call it, for selling the pharmaceutical grade of the krill oil.

"I want to just reemphasize that point you made is that the situation has been de-risked in several ways. The fact that the raw material that Neptune sells as Neptune Krill Oil already has a clinical study showing that there’s an improvement in the triglycerides, the LDL and the HDL. But even for the pharmaceutical grade, there are some preclinical studies that we’ve done going head to head with Lovaza where the CaPre, the pharmaceutical product that’s been going through Phase I, Phase III, has actually showed superiority over Lovaza in reducing triglyceride. So it is something that I always like to refer to as a de-risked for this situation. It’s not like your typical biotech that is hoping to demonstrate an effect in a phase II or phase III, we already have shown that in other models."

"I actually recently added a slide at the end of my presentation and I basically drew three circles. In one of the circles, I drew and I included in there the statin market with a $35B value. I drew another circle that had the Niaspan, which is the drug that Abbott sells and increases HDL and that’s $2B and then on the top I had Amarin and Lovaza on there that reduce triglycerides. Then, I have Neptune in there that overlaps all three circles and basically, I put a question mark on there and I leave it to the investors to see what they think the real value of it is if you get to touch a little bit of all those three circles."

Our informative and candid interview with Massrieh appears below:

Keryx Announces Positive Top-Line Results from Phase 3 Study; Medgenics Files for Orphan Drug Designation for INFRADURE

Tue, 24 Apr 2012 14:31:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 23, 2012.

Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX), announced its Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii), has announced positive top-line results from a Phase 3 study of ferric citrate in Japan for the treatment of hyperphosphatemia in end-stage renal disease patients on hemodialysis. This study is part of an ongoing Phase 3 program for ferric citrate in Japan for the treatment of hyperphosphatemia.

The Phase 3 study, conducted in Japan, was an open-label, randomized study evaluating the efficacy and safety of ferric citrate against an active control, sevelamer hydrochloride, over 12 weeks in hemodialysis patients with hyperphosphatemia. In the top-line results, which evaluated the change of serum phosphorus from baseline, the primary endpoint of efficacy met non-inferiority to sevelamer hydrochloride. Furthermore, there were no clinically significant findings on safety and tolerability of ferric citrate within the treatment period.

JT/Torii stated that it is AIMing to submit the marketing application for ferric citrate in Japan in the fiscal year ending March 31, 2013.

Ron Bentsur, Chief Executive Officer of Keryx, said, "We congratulate our partner, JT/Torii, on their successful Phase 3 study and we are excited by their progress. We are also encouraged about our partner's plans to file their marketing application in Japan within less than a year, similar to our expected timelines for the U.S. NDA and European MAA filings." Mr. Bentsur added, "We are enthusiastic about Zerenex's potential differentiated product profile and its prospects for becoming an important part of the treatment of hyperphosphatemia in dialysis patients worldwide."

Zerenex" (ferric citrate), a ferric iron-based phosphate binder, is also in a Phase 3 clinical program in the United States for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis, which is being conducted pursuant to a Special Protocol Assessment agreement with the FDA.

Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex from Panion & BF Biotech, Inc.

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Medgenics, Inc. (NYSE: MDGN) announced it has filed for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for INFRADURE™ for the treatment of hepatitis D. INFRADURE is based on Medgenics' proprietary tissue-based Biopump™ platform technology, which uses the patient's own tissue to continuously produce and deliver therapeutic proteins, such as interferon-alpha for use in the treatment of hepatitis.

Orphan Drug Designation carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an expedited regulatory process.

Also Monday:

Abbott (NYSE: ABT) and St. Jude Medical (NYSE: STJ) today announced Choice Alliance, a multi-year joint initiative that provides mutual U.S. customers access to a robust portfolio of interventional cardiology, cardiac rhythm management, electrophysiology and intravascular imaging and diagnostic technologies.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the election of Dennis A. Ausiello, M.D. to its Board of Directors and Scientific Advisory Board.

Pomerantz Haudek Grossman & Gross LLP is investigating clAIMs on behalf of investors of Ardea Biosciences, Inc. (NASDAQ: RDEA) (ISIN: US03969P1075) concerning the proposed acquisition of Ardea by AstraZeneca in a cash transaction valued at approximately $1.26 billion.

Array BioPharma Inc. (Nasdaq:ARRY) will report financial results for the third quarter of fiscal 2012 on Monday, April 30, 2012, and will hold a conference call on Tuesday, May 1, 2012 at 9:00 a.m. Eastern time to discuss these results.

Baxter International Inc. (NYSE:BAX) will webcast its annual meeting of shareholders on Tuesday, May 8, 2012, at 9:00 a.m. Central Time.

BioLineRx Ltd. (NASDAQ:BLRX) (TASE:BLRX.TA), a biopharmaceutical development company, announced the release today of its investor relations app for iPhone, now available for free at the Apple App store on the iPhone or at http://bit.ly/I6oKhw.

BioScrip, Inc. (NASDAQ: BIOS) (the “Company”) today announced that Hai V. Tran has been appointed as Senior Vice President, Chief Financial Officer and Treasurer effective May 14, 2012.

BioTime, Inc. (NYSE Amex: BTX) announced today that David Warshawsky, Ph.D., CEO of BioTime’s subsidiary LifeMap Sciences, Inc. will provide and update on product development at an investor meeting in New York City today.

Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that Biovest and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) have entered into a Cooperative Research and Development Agreement (CRADA) to further develop Biovest’s hollow fiber perfusion bioreactors as a flexible and modular manufacturing platform for the rapid, robust and cost-effective production of medical countermeasures to emerging and genetically engineered infectious diseases.

Capsalus Corp. (OTCBB: WELL and, temporarily, OTCBB: WELLE), today announced that the necessary revenue numbers for its fourth quarter are not yet available to include in its Fiscal 2011 10-K annual report for the fiscal year ending Dec. 31, 2011 due to a required change in GeneLink Biosciences, Inc. (OTCBB: GNLK) auditors.

Catalyst Health Solutions, Inc., (NASDAQ: CHSI) today announced that Mercer, one of the world’s leading human resource consulting firms, has selected Catalyst Rx to participate in the Mercer Pharmacy Collective making them a preferred provider of Pharmacy Benefit Management (PBM) services for the employers belonging to the Mercer Pharmacy Collective.

Compugen Ltd. (NASDAQ: CGEN) today announced that the Company will host a conference call at 10:00 AM EST on Tuesday, May 1, 2012 to review first quarter 2012 results.

Compugen Ltd. (NASDAQ: CGEN) announced today that Dr. Mary Haak-Frendscho, Compugen Inc.'s Executive Chairperson of the Board, will deliver the keynote address at the 7th International China Pharmaceutical R&D Summit, on April 24, 2012 in Shanghai, China.

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that it has received a favorable ruling from the NASDAQ Hearings Panel (the “Panel”), whereby the Panel has granted the Company’s request to remain listed on The NASDAQ Capital Market.

Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company will host a webcast and conference call to discuss its first-quarter 2012 financial results on May 1, 2012.

Five Star Quality Care, Inc. (NYSE: FVE) today announced that it will host a conference call in conjunction with the announcement of its first quarter 2012 financial results.

Illumina, Inc. (NASDAQ:ILMN) today announced its financial results for the first quarter of 2012.

InSite Vision Incorporated (OTCBB: INSV) announced today that it will report financial results for the first quarter ended March 31, 2012 on Tuesday, May 1, 2012.

International Stem Cell Corporation (ISCO.OB), today announced that several of its senior scientists, led by Dr. Ruslan Semechkin Vice President Research and Development, will present the results of their most recent experiments on the therapeutic use of human parthenogenetic stem cells (hpSCs) in Parkinson’s disease at the 64th Annual Meeting of American Academy of Neurology in New Orleans (April 21 to 28 2012).

International Stem Cell Corporation (OTCBB: ISCO) today announced it has appointed MZ Group as its investor relations advisor.

Landec Corporation (Nasdaq:LNDC), a company that develops and markets patented products for food, agricultural and biomedical applications, announced today that its wholly owned food subsidiary, Apio, Inc., has acquired GreenLine Foods, Inc. from The Riverside Company, a global private equity firm.

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has filed for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for INFRADURE™ for the treatment of hepatitis D. INFRADURE is based on Medgenics’ proprietary tissue-based Biopump™ platform technology, which uses the patient’s own tissue to continuously produce and deliver therapeutic proteins, such as interferon-alpha for use in the treatment of hepatitis.

Natus Medical Incorporated (NASDAQ:BABY) today announced that Natus management will host an investment-community conference call this morning, Monday, April 23, 2012 beginning at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) to discuss the acquisition announced earlier today.

NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of neurological complications of diabetes announced that it will support a clinical study entitled “Evaluation of the Effect of Intensive Diabetes Control Through Non-surgical Intensive Lifestyle Modifications and Weight Reduction on Diabetic Peripheral Neuropathy”.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will report first quarter 2012 financial results following the close of the U.S. financial markets on Monday, May 7, 2012.

Spectrum Pharmaceuticals (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that in order to meet the needs of cancer patients in the United States, the Company has substantially increased its manufacturing capacity of FUSILEV® (levoleucovorin) for injection, since its approval for use in advanced metastatic colorectal cancer.

W. R. Grace & Co. (NYSE: GRA), in partnership with Formac Pharmaceuticals NV, a research and development pharmaceutical company, announced today positive data from initial human studies enabled by the companies’ unique mesoporous silica-based drug delivery technology.

What Happens To BioSante Pharmaceuticals Now?

Fri, 20 Apr 2012 14:38:00 -0400

Last December, shares of BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) imploded after the firm’s sexual dysfunction drug LibiGel failed in two late-stage clinical trials. Have we heard the end of that program? Probably not, actually.
Stephen M. Simes, BioSante’s president & CEO sat down for a revealing video interview with BioMedReports and explains, quite candidly, what happened and where his firm is headed now.

BioSante Pharmaceuticals, Inc.

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“We continue to analyze those data and hope to come up with perhaps a different strategic way to attack the issue either to redo LibiGel clinical trials or to find another use for our safety data, “explains Simes. “I talked about our efficacy data so far, the safety data are quite remarkable. We’re now in the fifth year of the LibiGel testosterone safety study and we’re showing very clearly that testosterone is safe for women. So the question is how best to use those safety data, which is now the biggest database of safety of testosterone in women that’s ever existed.

“We expect to meet with the FDA and be able to announce the next steps for LibiGel, which is, still quite an interesting opportunity because today as you know there is no product approved for the treatment of female sexual dysfunction.”

Simes is expected to present a corporate update at the BioCentury Future Leaders in the Biotech Industry Conference in New York today at 11:00 am EDT. In the meantime, the revealing interview can be seen below.

Roche Decides Not to Extend its Offer For Illumina; Vertex Advances Goal of Further Treatment for People With Hepatitis C

Thu, 19 Apr 2012 13:00:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 18, 2012.

Roche (SIX: RO, ROG; OTCQX: RHHBY) released the following statement based on preliminary estimates indicating the re-election of the incumbent directors of Illumina, Inc. (NASDAQ: ILMN) at the Illumina annual meeting:

In view of the apparent re-election of the incumbent directors of Illumina, Roche has decided not to extend its $51.00 cash tender offer for all of the shares of Illumina. The offer will expire at 6:00 p.m., New York City time, on April 20, 2012.

Severin Schwan, CEO of Roche said: “We continue to hold Illumina and its management in very high regard but, with access only to public information about Illumina’s business and prospects, we do not believe that a price above Roche’s offer for Illumina of $51.00 per share would be in the interest of Roche’s shareholders.” Schwan continued: “We have throughout this process desired to engage in a constructive dialogue with Illumina’s management, listen to its views of value and prospects, and offer a fair and adequate price to Illumina’s shareholders. But in the absence of such discussions, our duty to be disciplined with the assets of Roche’s shareholders has led to this decision. Roche will continue to consider options and opportunities to develop further its portfolio of businesses in order to expand its diagnostics leadership position.”

About the Offer - On January 27, 2012, Roche commenced a tender offer to acquire all outstanding shares of Illumina for $44.50 per share in cash and increased its offer on March 29, 2012 to $51.00 per share in cash for an aggregate of approximately $6.8 billion on a fully diluted basis. The increased offer represents a substantial premium to Illumina’s unaffected market prices: a premium of 88% over Illumina’s closing stock price on December 21, 2011 – the day before market rumors about a potential transaction between Roche and Illumina drove Illumina’s stock price significantly higher – and an 84% premium over the one-month historical average and a 64% premium over the three-month historical average of Illumina’s share price, both as of December 21, 2011.

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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced data from a retrospective subanalysis of the Phase 2 PROVE 2 study that showed that 100 percent (12/12) of patients with the IL28B CC genotype who were new to treatment achieved a viral cure (sustained viral response, or SVR) with a total of 12 weeks of treatment with INCIVEK™ (telaprevir) tablets, pegylated-interferon and ribavirin.

These data support Vertex's ongoing Phase 3b study that is evaluating a total treatment duration as short as 12 weeks in people with the IL28B CC genotype. Data from the PROVE 2 subanalysis and 13 other abstracts on INCIVEK and Vertex's medicines in development for the treatment of hepatitis C will be presented at the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 18 to 22, 2012.

Also Wednesday:

Agilent Technologies Inc. (NYSE: A) today introduced the Agilent 1290 Infinity Quaternary LC system, the first quaternary UHPLC system to deliver the accuracy and precision of binary systems.

Results from AspenBio Pharma’s (NASDAQ: APPY) recently completed 503-patient pilot study of AppyScore™ will be presented from the podium at the upcoming annual scientific meeting of the Society for Academic Emergency Medicine (SAEM) being held May 9-12, 2012 in Chicago.

BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer Michael D. West, Ph.D. will present at the Future Leaders in the Biotech Industry conference on Friday, April 20, 2012, 9:00 a.m. EDT, at the Millennium Broadway Hotel in New York City.

The law firm of Brower Piven, A Professional Corporation, has commenced an investigation into possible breaches of fiduciary duty to current shareholders of Catalyst Health Solutions, Inc. (NASDAQ: CHSI) (“Catalyst”) and other violations of state law by the board of directors of Catalyst relating to the proposed acquisition of the company by SXC Health Solutions Corp. (“SXC”).

Cerus Corporation (NASDAQ: CERS) announced today that it has signed a two-year agreement with the General Hospital of Vienna (AKH) to supply the INTERCEPT Blood System for platelets.

Dyax Corp. (NASDAQ:DYAX) will host a webcast and conference call, including an open question and answer session, Tuesday, April 24, 2012.

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that 30 abstracts examining the company’s products and investigational agents for hepatitis B and C have been selected for presentation at the 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) taking place April 18-22 in Barcelona, Spain.

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC-NEWS), a clinical stage biotechnology company that is focused on developing new immune-based products to treat and diagnose cancer, announced today that Manish Singh, PhD, President and Chief Executive Officer of the Company will be presenting at the 19th Annual Future Leaders in the Biotech Industry Conference in the Millennium Broadway Hotel & Conference Center in New York City.

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that data from the ASCEND-PD Phase III clinical study involving IPX066 will be presented in a Platform Presentation at the 64th Annual Meeting of the American Academy of Neurology in New Orleans, Louisiana, held from April 21 to April 28.

Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on developing clean, sustainable solutions for plastics, chemicals and energy, today announced the opening of its new office in Cologne, Germany.

NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes reported today that it has filed a premarket notification, or 510(k), with the Food and Drug Administration (FDA) for its SENSUS Pain Therapy device.

Nuvilex, Inc. (OTCQB:NVLX) reports that the Chairman of its associate company, SG Austria, Prof. Walter H. Gunzburg, has been invited to present data about the proprietary encapsulation of living cell technology, in particular for the treatment of pancreatic cancer and other solid tumors, at the 8th Annual Meeting of the Organisation for Oncology and Translational Research (OOTR).

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that it plans to release first quarter 2012 results on May 1, 2012, before the market opens.

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that its wholly-owned subsidiary, Sucampo AG, has implemented a Named Patient Program (NPP) to permit access to AMITIZA (lubiprostone) for patients with chronic idiopathic constipation (CIC) in the European Union (EU), Iceland and Norway.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) presented preclinical results today at the 3rd European Lung Cancer Conference in Geneva, Switzerland that show ganetespib, a potent inhibitor of heat shock protein 90 (Hsp90), equally inhibits growth of both crizotinib-sensitive and -resistant cancer cells driven by the EML4-ALK fusion protein regardless of ALK mutation status.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced new data from the Company’s expanding central nervous system (CNS) portfolio will be featured at the 64th American Academy of Neurology (AAN) Annual Meeting in New Orleans, LA, April 21-28, 2012.

Viral Genetics (Pinksheets: VRAL) today published its April 2012 Letter to Shareholders.

As flu season approaches in Southeast Asia, Walgreens (NYSE, NASDAQ: WAG) today announced a donation of 375,000 doses of seasonal flu vaccine to Lao People’s Democratic Republic (referred to as Lao PDR or Laos).

Walgreens (NYSE: WAG) (NASDAQ: WAG) today named Reuben Slone senior vice president of supply chain management. In this position, Slone will have leadership responsibility for distribution, transportation, systems integration and engineering, Lean and Six Sigma supply chain initiatives and community outreach, reporting to President of Community Management Mark Wagner.

Positive Results in Abbott's Treatment for Parkinson's Disease; PROLOR Announces Positive Results of Its Obesity/Diabetes Drug

Wed, 18 Apr 2012 16:00:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 17, 2012.

Abbott (NYSE: ABT) announced the results from a Phase 3 trial evaluating the company's investigational compound for advanced Parkinson's disease, levodopa-carbidopa intestinal gel (LCIG). The study showed that patients treated with LCIG for 12 weeks reported clinically meaningful and statistically significant improvements in "off" time compared to levodopa-carbidopa immediate release (IR) tablets, without increasing troublesome dyskinesia. "Off" time refers to the periods of poor mobility, slowness and stiffness experienced by patients with Parkinson's disease. The results from the study will be presented as part of the Emerging Science program (formerly known as Late-Breaking) at the American Academy of Neurology's 64th Annual Meeting in New Orleans on April 25.

This study was conducted to determine the efficacy, safety and tolerability of continuous LCIG infusion in patients with advanced Parkinson's disease compared to standard levodopa-carbidopa IR tablets. LCIG contains the same active medication as levodopa-carbidopa IR tablets but in gel form and is administered directly into the small intestine via a procedurally-implanted tube connected to a portable pump. At baseline, patients enrolled in the study had Parkinson's disease for an average of 10.9 years and experienced an average of 6.6 hours of "off" time a day.

Key Findings: The primary efficacy endpoint was change from baseline in daily "off" time (16 waking hours) at 12 weeks.

Mean "off" time at 12 weeks decreased by 4.0 hours per day with LCIG, an average of 1.91 fewer hours of "off" time compared to levodopa-carbidopa IR tablets.

The secondary efficacy endpoint was change from baseline in daily "on" time without troublesome dyskinesias. "On" time refers to periods of good motor symptom control.

Mean "on" time improved by 4.1 hours with LCIG, an average of 1.86 more hours compared to levodopa-carbidopa IR tablets.

Treatment-emergent adverse events (AE) occurred in 35 patients on LCIG (95 percent) and in 34 patients on levodopa-carbidopa IR tablets (100 percent) and were similar between the two treatment groups. The most common adverse events were complication of device insertion (51 percent), abdominal pain (42 percent), procedural pain (32 percent), nausea (25 percent), constipation (21 percent), orthostatic hypotension (18 percent), post-operative wound infection (17 percent), and incision site erythema (16 percent). Treatment-related serious adverse events (SAE) were reported in five patients (14 percent) in the LCIG arm and in seven patients (21 percent) in the levodopa-carbidopa IR tablets arm. All patients that experienced an SAE recovered. Premature discontinuation because of AEs was low (4.2 percent), and similar between treatment groups.

"These results demonstrate that continuous delivery of levodopa-carbidopa intestinal gel produces statistically meaningful improvements in advanced PD patients by decreasing 'off' time and increasing 'on' time without troublesome dyskinetic symptoms," said Dr. C.W. Olanow, M.D., Professor of Neurology and Neuroscience at the Mount Sinai School of Medicine in New York City. "These benefits in a patient group that cannot be satisfactorily controlled with standard levodopa, represent an important step forward in our efforts to treat advanced PD patients."

Parkinson's disease is a movement disorder resulting from progressive loss of brain cells that produce the chemical dopamine. Dopamine helps control movement of the body. Early on in the disease, patients usually respond well to medications that increase dopamine levels. As the disease progresses, the effect of oral medications may not last as long and can cause increasing side effects.

Patients with advanced Parkinson's disease may experience fluctuations between periods of poor mobility or slowness and periods when disease symptoms are well controlled. The loss in mobility or slowness/stiffness and periods of good symptom control are referred to as "off" time and "on" time, respectively. When "off" time increases, a patient's "on" time progressively shortens. Additionally, many patients experience dyskinesias, which are involuntary movements associated with treatments used to manage Parkinson's disease. Some of these involuntary movements can bother patients and make it difficult to perform activities. These are referred to as "troublesome dyskinesias."

"Parkinson's disease is a devastating condition that gets increasingly more difficult to treat as it progresses. In the later stages, patients have a disease burden that negatively impacts their quality of life and can impact normal activities of daily living," said Robert Lenz, M.D., divisional vice president, Global Pharmaceutical Research and Development, Abbott. "Many patients at this stage are in need of additional treatment options, and we hope that LCIG may soon be a viable option for some of these patients."

LCIG is an investigational therapy that is currently being evaluated in patients with advanced-stage Parkinson's disease in additional Phase 3 clinical trials in the U.S. It is approved in 40 countries outside the U.S.

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PROLOR Biotech, Inc. (NYSE: PBTH) reported positive preclinical results from an animal study of its long-acting obesity/Type II diabetes drug candidate MOD-6030. The study was designed to measure the potential therapeutic effect of MOD-6030 injected once weekly as measured by weight loss, reduction in food intake, glycemic control and cholesterol levels. The study results will be presented at GTC's 5th Diabetes Drug Discovery and Development Conference on April 19, 2012 in Boston, MA.

In the study, MOD-6030 administered to diet-induced obese (DIO) mice once weekly over a 30-day period demonstrated significant efficacy in reducing weight, lowering blood glucose levels, increasing insulin sensitivity and reducing cholesterol levels as compared to a group that received placebo. Animals in the placebo group showed minimal changes in the study parameters, while the animals receiving MOD-6030 achieved on average a 28% reduction in weight, a 29% reduction in food intake, a 19% reduction in blood glucose levels and a 57% reduction in cholesterol levels. Body composition analysis showed that the weight loss resulted specifically from reductions in body fat.

"We believe there is great demand among obese patients and their physicians for therapies that will help patients lose weight and reduce elevated glucose levels resulting from obesity with minimal side effects and a favorable administration profile," said Dr. Abraham Havron, CEO of PROLOR. "In this study in animals, our MOD-6030 therapy demonstrated a unique combination of achieving substantial weight loss and improved glycemic profiles while also significantly lowering cholesterol levels."

Dr. Havron continued, "MOD-6030 is a long-acting version of a native peptide that acts as a natural satiety signal to reduce food intake, and we believe it has the potential be a major new treatment for obesity and Type II diabetes that is both effective and safe. We are currently on track to initiate the first human clinical trial of MOD-6030 in 2013."

MOD-6030, a GLP-1/Glucagon dual receptor agonist peptide, is a long-acting version of oxyntomodulin, a naturally occurring hormone that acts as a natural satiety signal to reduce food intake and increase energy expenditure following food ingestion. Previous third-party studies in humans showed that the native oxyntomodulin can reduce appetite and food intake, leading to significant weight loss without apparent side effects. However, as a result of its very short half-life, oxyntomodulin has to be administered via three daily injections. PROLOR developed MOD-6030, its longer-acting version, by combining the naturally occurring hormone with the company's proprietary Reversible PEGylation technology designed to increase the half-life of therapeutic peptides and small molecules.

Also Tuesday:

Affymetrix, Inc. (NASDAQ: AFFX) today announced that its first quarter 2012 operating results will be reported after market close on Thursday May 3, 2012.

BioClinica®, Inc., (NASDAQ: BIOC), a leading global provider of clinical trial management solutions, will release its financial results for the first quarter ended March 31, 2012 on Wednesday, May 9, 2012.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that Stephen M. Simes, BioSante’s president & CEO will present a corporate update at the BioCentury Future Leaders in the Biotech Industry Conference in New York on April 20, 2012 at 11:00 am EDT.

Celgene Corporation (NASDAQ: CELG) senior management will host a conference call and live audio webcast on Thursday, April 26, 2012 at 9 a.m. ET to discuss the company’s first quarter 2012 financial and operational results.

In conjunction with the Charing Cross International Symposium (CX34), which concludes today in London, Minneapolis-based Medtronic, Inc. (NYSE: MDT) announced its plans for the imminent start of the IN.PACT Global SFA clinical study, an international research program to evaluate the treatment of peripheral artery disease using the company’s IN.PACT Admiral™ drug-eluting balloon.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that a Phase 4 study of ENTEREG® (alvimopan) in patients undergoing radical cystectomy met its primary endpoint of time to achieve recovery of both upper and lower gastrointestinal (GI) function.

Derma Sciences, Inc. (Nasdaq: DSCI) (“Derma Sciences”), a medical device and pharmaceutical company focused on advanced wound care, has completed its previously announced acquisition of MedEfficiency, Inc. (“MedEfficiency”), manufacturer of the TCC-EZ™ Total Contact Cast system.

Dyax Corp. (NASDAQ:DYAX) and Eclipse Therapeutics, Inc., a privately held oncology company, announced today that Dyax has granted Eclipse an exclusive worldwide license for the development and commercialization of preclinical fully-human antibodies discovered using Dyax’s gold-standard phage display technology for use in oncology indications.

Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today announced that reported earnings per share equaled $0.72 in the fourth quarter of fiscal 2012.

Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, today announced that it will host a meeting on Wednesday, June 20, 2012 to review its late-stage product development pipeline and commercialization strategy.

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced the appointment of Linda Rosenstock, M.D., M.P.H. to its Board of Directors.

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced the treatment of the first patient in a Phase 2 clinical trial of IMO-3100, the Company’s lead Toll-like receptor (TLR) inhibitor for the treatment of autoimmune diseases, in patients with moderate to severe plaque psoriasis.

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer therapeutics using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced the start of clinical testing with its IMGN529 product candidate.

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics, today announced that the Investigational New Drug (IND) application for its IMGN853 product candidate is now active.

Medidata Solutions (NASDAQ: MDSO), a leading global provider of cloud-based clinical development solutions, today announced that it will release its first quarter 2012 financial results before the open of the market on Tuesday, May 1, 2012.

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) to initiate a Phase IIb multi-center, 100-patient clinical trial.

Mentor Capital, Inc. (Pink Sheets:MNTR) reports that its proprietary Cancer Immunotherapy Index has appreciated 47.3% during the first quarter of 2012.

NeuroMetrix, Inc. (Nasdaq: NURO) today said it plans to issue its 2012 first quarter financial results before the opening of the market on April 24, 2012.

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that its board of directors has declared its next ongoing quarterly cash dividend of $0.05 per share to its shareholders will be distributed on Tuesday, May 8, 2012, for shareholders of record as of Friday, April 27, 2012.

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced it will host a teleconference and webcast with management to discuss the first quarter 2012 financial results, provide an update on the Company’s business, and discuss expectations for the future.

Value Plastics, a Nordson Company (Nasdaq: NDSN), announces the PharmaLok™ Series – a new line of ergonomic, single-use sanitary clamps for securing fittings to bag ports and filters in the biopharmaceutical market.

Walgreens (NYSE: WAG)(NASDAQ: WAG) Executive Vice President and Chief Financial Officer Wade Miquelon will present during the Barclays Capital 2012 Retail & Restaurants Conference in New York City at approximately 3:30 p.m. Eastern time Tuesday, April 24.

http://www.biomedreports.com/2012041792884/chairman-a-ceo-of-tapimmune-excited-about-firms-new-her2neu-antigen-technology.html

Tue, 17 Apr 2012 15:21:00 -0400

In what is seen as a game changing event for the emerging biotech, TapImmune (OTCBB:TPIV) announced on Monday that it had signed an Exclusive Agreement with the Mayo Foundation for Education & Research, Rochester, MN, to License a proprietary MHC Class I HER2/neu antigen technology.

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"It's a new antigen that we've licensed from the Mayo Clinic and it's an antigen that no one recognized before for the HER2/neu receptor." explained Dr. Glynn Wilson, Chairman & CEO at TapImmune during an exclusive interview with BioMedReports. "The existing products in the market don't go the same pathway and so they're not as effective; and so we think that with our other approaches to HER2/neu, we'll have a real advantage and give us a leading position in development of a vaccine for HER2/neu -- both for therapeutic and hopefully in the future, prophylactic."

"It's a new antigen that we've licensed from the Mayo Clinic and it's an antigen that no one recognized before for the HER2/neu receptor." explained Dr. Glynn Wilson, Chairman & CEO at TapImmune during an exclusive interview with BioMedReports. "The existing products in the market don't go the same pathway and so they're not as effective; and so we think that with our other approaches to HER2/neu, we'll have a real advantage and give us a leading position in development of a vaccine for HER2/neu-- both for therapeutic and hopefully in the future, prophylactic."

After 20 years of HER2/neu vaccine development the scientific team at the firm feels they have a far greater understanding of the target, and indeed of the needs of cancer immunotherapy.

Early on peptide vaccine studies showed that 'killer' T cells could be generated. At around the same time different peptides were shown to generate 'helper' T cells. To date however, we have not seen a combined approach that provides a naturally processed killer cell target and a collection of broadly reactive HER2/neu derived helper peptides.

With more than 200,000 women in the U.S. being diagnosed with breast cancer each year, 75 percent of which test positive for the HER2 receptor, but only 25 percent are eligible candidates for Roche-Genentech's breakthrough drug Herceptin, a $5B a year product and some new drug candidates in late stage clinical development, we still don't have a comprehensive approach.

Observers believe that this is where this collaboration between TapImmune and the Mayo Clinic enters and bridges the gap, making what the scientific team at TapImmune believes will be the broadest and most comprehensive HER2/neu breast cancer platform available.

We know now that killer cell targets absent of T cell 'help' offer only short lived responses and do not generate T cell memory. In addition, scientists have figured out that using so called 'universal' T cell helper peptides does not truly deliver the need for 'locally available' helper peptides. These helper T cells need their antigens for stimulation and targeting in the actual tumor, where they need to function.

Without getting too technical it boils down to this. Killers need both naturally processed targets AND they need T cell help. While helper T cells need stimulation as well, and this has to be accomplished in the same microenvironment of the tumor where these functions are being performed. This means that the helper peptides must be natural targets as well, and they have to be found in the same place and time as the killer cells.

Will investors continue to embrace the development at TapImmune as they begin to grasp the implications? The pipeline programs at the firm are very early, but volume and interest in the stock has been rising-- just as it has for other stocks with development programs in the same space. This could be an important differentiator for the micro-cap company specializing in the development of innovative gene based immunotherapeutics and vaccines in the areas of oncology and infectious disease.

Our video interview with Dr. Glynn Wilson, Chairman & CEO at TapImmune appears below:

Medtronic Initiates Landmark U.S. Drug-Eluting Balloon Study; Mylan Launches First Generic Version of Lescol® Capsules

Mon, 16 Apr 2012 13:21:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 13, 2012.

Medtronic, Inc. (NYSE: MDT) announced the start of the Medtronic IN.PACT SFA II study, the company's first U.S. clinical trial for its line of IN.PACT drug-eluting balloons.

The first patients in this landmark study were treated this week by Dr. Ash Jain at Washington Hospital in Fremont, Calif., and Dr. Brian Bigelow at St. Vincent Hospital in Indianapolis; Dr. Monica Hunter at Christ Hospital in Cincinnati is planning to treat a patient in the study as early as next week. Drs. Jain, Bigelow and Hunter are the principal investigators at their respective trial site.

Peripheral artery disease is estimated to affect eight to 12 million people in the United States alone. A prevalent form of cardiovascular disease, lower-extremity peripheral artery disease is a prime cause of claudication (ischemic leg pain) and immobility, critical limb ischemia and amputations.

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Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol® Capsules. This product is indicated for the treatment of both familial and nonfamilial hypercholesterolemia and mixed dyslipidemia. It is also indicated for the secondary prevention of cardiovascular disease.[1]

Pursuant to a settlement and license agreement with Novartis, Mylan was granted a license permitting launch prior to the expiration of the pediatric exclusivity associated with U.S. Patent No. 5,356,896, which expires on June 12, 2012.

Lescol Capsules had U.S. sales of approximately $27.9 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan has begun shipping its generic version of this product.

Also Friday:

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will present at the 19th Annual Future Leaders in the Biotech Industry Conference on Friday, April 20, 2012, at 11:00 a.m. Eastern Time at the Millennium Broadway Hotel in New York City.

Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it will webcast its Annual Shareholders’ Meeting to be held on Thursday, April 26th at the Hyatt Regency Suites, Palm Springs, 285 N. Palm Canyon Drive, Palm Springs, Calif.

Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceuticals U.S.A. (TPUSA) today announced that the Centers for Medicare and Medicaid Services (CMS) has granted a unique product reimbursement code, or Q-code, for OMONTYS® (peginesatide) Injection.

Allergan, Inc. (NYSE: AGN) announced today that April 15, 2012 will mark the 10-year anniversary of the U.S. Food and Drug Administration’s (FDA) approval of BOTOX® Cosmetic (onabotulinumtoxinA) to improve the look of moderate to severe frown lines between the eyebrows in patients age 18-65.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be presenting at the BioCentury Future Leaders in the Biotech Industry Conference on Friday, April 20, 2012, at 11:00 a.m. ET in New York City.

Expanding its commitment to developing innovative treatments for cardiovascular disease and the evidence to support their adoption, Medtronic, Inc. (NYSE: MDT) announced today the start of the Medtronic IN.PACT SFA II study, the company’s first U.S. clinical trial for its line of IN.PACT drug-eluting balloons.

VisualMED Clinical Solutions Corp. (PINKSHEETS: VMCS) (FRANKFURT: VA6) announces it has entered into a partnership with the Maryland Center, Bowie State University, Intelaform and Verizon, as announced by the Maryland Center at Bowie State on Wednesday.

Abbott wins EU Approval for Use of Humira Drug; NeurogesX Provides Update on NGX-1998

Thu, 12 Apr 2012 13:08:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 11, 2012.

Humira, the best-selling arthritis drug that forms the cornerstone of Abbott Laboratories' (NYSE:ABT) pharmaceutical business, has been approved in Europe for ulcerative colitis, the U.S. drugmaker said.

The green light from the European Commission follows a positive opinion from the European Medicines Agency in February and marks the seventh indication for Humira in the European Union since its first approval in 2003.

Humira, one of the world's biggest-selling drugs with sales forecast by analysts to be around $9 billion this year, is the first self-injectable biologic therapy for ulcerative colitis, a chronic disease that causes ulcers in the colon.

=====

NeurogesX, Inc. (NASDAQ:NGSX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, announced the U.S. FDA has accepted the Company's request for an End-of-Phase 2 meeting to discuss the continued clinical investigation of NGX-1998 as a treatment for certain neuropathic pain conditions including, specifically, the Company's plans for entering NGX-1998 into Phase 3 development. The Company anticipates that the End-of-Phase 2 meeting will occur in the third quarter of 2012.

NGX-1998, NeurogesX' most advanced product candidate, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. The Company believes that the clinical data obtained to date should support moving to a Phase 3 clinical development program, which it believes can be initiated by the end of 2012.

The Phase 2 study that NeurogesX completed at the end of 2011 was a 12-week, multicenter, randomized, double-blinded, placebo-controlled clinical trial. Its protocol-specified objectives were met, including the primary endpoint of a percentage change from baseline as compared to placebo in a patient-reported numeric pain rating scale (NPRS) score during weeks two through eight. A total of 183 patients were treated in the Phase 2 study. Patients were randomized into one of three groups: NGX-1998 capsaicin 10% solution, NGX-1998 capsaicin 20% solution or placebo, according to an unequal allocation scheme of 2:2:1. NGX-1998 exhibited a dose response. Although no topical anesthetic was used during the second stage of the study, the patients were able to tolerate the treatment procedure. No patients discontinued the study due to adverse events, and the incidence of adverse events and serious adverse events in patients treated with NGX-1998 were similar to the placebo-treated group.

Also Wednesday:

Arrowhead Research Corporation (NASDAQ: ARWR), a nanomedicine company with development programs in RNA therapeutics and obesity, today announced that it has acquired Alvos Therapeutics, Inc. (formerly known as Mercator Therapeutics, Inc.), a privately-held company that licensed a large platform of proprietary human-derived homing peptides from MD Anderson Cancer Center (MDACC) and the method for their discovery.

ArQule, Inc. (NASDAQ: ARQL) today announced the pricing of an underwritten public offering of 7,150,000 shares of its common stock at a price of $7.30 per share.

BSD Medical Corporation (NASDAQ:BSDM) (the “Company” or “BSD”) announced today that the Company’s new Microwave Ablation System (MicroThermX®) products were showcased at the Company’s exhibition booth at the 37th annual scientific meeting of the Society of Interventional Radiology (SIR), which was held March 24 to 29, 2012 in San Francisco.

Cannabis Science, Inc. (OTCBB: CBIS.OB) a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is pleased to provide new photographs of the existing treatment for patient three who has a “worst case” of treatment resistant, Squamous Cell Carcinoma. Cannabis Science has received positive feedback from both the patient and his Oncologist.

Dyax Corp. (NASDAQ: DYAX) the manufacturer of KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older, has announced the launch of its HAE genetic counseling program.

InVivo Therapeutics Holdings Corp. (OTCBB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that CEO Frank Reynolds is scheduled to appear on local TV affiliates in Charlotte, Indianapolis and Greensboro.

Mannatech, Incorporated (NASDAQ: MTEX), the leading innovator and provider of naturally sourced supplements based on Real Food Technology® solutions, is pleased to announce that its annual global convention—MannaFest—will be held this week from April 12–14, in Fort Worth, Texas.

Mauna Kea Technologies (NYSE Euronext: MKEA), leader on the endomicroscopy market, today announced that the company's Board of Directors appointed new board member Gilles Brisson to the role of Chairman of the Board.

Medidata Solutions (NASDAQ: MDSO) announced today a major new release of Medidata Balance™, a randomization and trial supply management (RTSM) application which is part of Medidata’s comprehensive clinical cloud platform. Balance now provides the popular block randomization methodology in addition to the powerful and flexible dynamic allocation methodology it previously offered.

McKesson Corporation (NYSE: MCK) announced today that it has been selected by the Department of Veterans Affairs (VA), which runs the nation's largest integrated healthcare system, to continue as the VA's prime pharmaceutical supplier.

MMRGlobal, Inc. (OTCBB: MMRF) and temporarily (OTCBB: MMRFE) (the "Company") today announced that on April 5, 2012, it learned of an inadvertent omission, due to a formatting error, of the Item 9A information required in its Annual Report on Form 10-K for the fiscal year ended December 31, 2011, timely filed with the Securities and Exchange Commission ("SEC") on March 30, 2012 (the "10-K").

Nuvilex, Inc. (OTCQB:NVLX), through its Singapore-based biotech company associate, SG Austria, announced completion of substantial therapeutic antibody patent portfolio talks, culminating in the addition of the Exclusive Worldwide License to the existing SG Austria patent position for encapsulating therapeutic antibody-producing cells.

Obagi Medical Products, Inc. (Nasdaq:OMPI), a leader in topical aesthetic and therapeutic skin health systems, today announced it will report financial results for the first quarter ended March 31, 2012 on Thursday, May 3 after market close, followed by an investor conference call on the same day at 4:30 p.m. EDT (1:30 p.m. PDT).

Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares in the offering are to be sold by Pacira.

PearlBrite™ Concepts, Inc. ("PearlBrite"), a wholly owned subsidiary of Delta Entertainment Group, Inc. ("Delta Entertainment") (OTCQB: DENG) (OTCBB: DENG), will be releasing 1 minute and 2 minute short form infomercials nationally to promote its new at home consumer teeth whitening kit & pen, which whitens teeth 2 to 10 shades, offering a full money back guarantee (www.pearlbrite.net) this month.

Proteonomix, Inc. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today announced the termination of the Research Agreement and Phase 1 clinical trial with the University of Miami.

PURE Bioscience, Inc. (NASDAQ: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today reported the launch of the PURE Complete Cleaning, Sanitizing and Disinfecting System.

St. Louis–based law firm Carey, Danis & Lowe announces a lawsuit against Pfizer Inc. (NYSE: PFE), maker of the antidepressant drug Zoloft, that was originally filed in St. Louis Circuit Court then removed to federal court by the drugmaker, has been ordered back to the state court.

Repligen Corporation (NASDAQ:RGEN) today announced that Mr. Michael A. Griffith has been appointed to serve on the Company’s Board of Directors. Mr. Griffith, 53, has extensive leadership experience in the bioprocessing and biopharmaceutical industries, as well as significant commercial and investment banking expertise.

Roche (SIX: RO, ROG; OTCQX: RHHBY) today sent an open letter to shareholders of Illumina, Inc. (NASDAQ: ILMN) urging them to vote the GOLD proxy card for Roche’s independent director nominees and other proposals at the 2012 Illumina annual meeting to be held on 18 April 2012.

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of consulting services and software for pharmaceutical discovery and development, today announced that further testing shows that the newest molecule the Company has designed to inhibit the malaria parasite is nearly three times more potent as an inhibitor of the drug-sensitive 3D7 strain of the malaria parasite than its best previous molecule.

RegMed Competitive and Market Intelligence 4/11/12, Stocks rallied 1% through mid-day, regaining ground but, buying remains subdued as universe adds small appreciative moves

Wed, 11 Apr 2012 13:31:00 -0400

The 6 W’s: Who, what, where, when, why and what of it …

Today’s Gospel: A good start to Tuesday post a downdraft … a lot more green on the screen …

Aastrom (ASTM) – ($0.02 <0.98%> to $2.07) and Cytori (CYTX) up $0.22 <+10.48%> to $2.32) … have kept my e-mail and VM busy and lit-up; Cryo-Cell (OTC BB: CCEL) keeps bouncing +$0.12 <+5.50%> to $2.30); Neuralstem is up on peer results of clinical trial (+$0.03 <2.79%> to $1.10.

Dendreon (DNDN) is moving slowly back (+0.12 <2.05%> to $9.37); ImmunoCellular (OTC BB: IMUC) up at +$2.78; ThermoGenesis is up on China’s product approval (+$0.068 <8.10%> to $0.98 … following upward daily moves …

Not trending but, moving … are Geron (GERN), Opexa (OPXA), Osiris (OSIR), StemCells (STEM) and International Stem cell (OTC BB: ISCO).

Even, NeoStem is up ($0.014 <+4.52%> to $0.324> avoiding the $0.30 bottomfollowing the minimally priced toxic offering raising a paltry $6M – so much dilution … so little a solution …

Verastem seems to be quite stable over declines and better market days …+$0.61 <+5.76%> to $11.72.

Is Cytomedix (OTC BB: CMXI) is down even with publication of AutoloGel wound healing data but, the question concerns are multiple product targets and visibility or are they … “following the OPXA mantra, don’t talk unless spoken to” – they share a director.

We need a universe of oppurtunity … not elasticity!!

EconRecon: Import prices rose 1.3% in March, logging its biggest gain in nearly a year. Economists had expected import prices to rise 0.8% last month. February’s data was revised to show a 0.1% decline instead of the previously reported 0.4% increase.

Mid-Day: The NASDAQ is UP +30.89 (+1.03%) to 3,022.11 while the Dow is UP +108.23 (+0.85%) to 12,824.16.

Mid-Day Market Commentary: Stocks rallied at the open Wednesday, following 5 consecutive days of declines. Stocks have moved mostly higher in mid-day trading on Wednesday, regaining some ground after falling sharply in the previous session. The major averages have pulled back off their highs for the young session but remain firmly positive. The early strength on Wall Street is partly due to a positive reaction to the release of quarterly results … Nonetheless, buying interest has remained somewhat subdued amid lingering concerns about the global economic outlook.

Who is UP … Mid-day:

Aastrom (ASTM);
Athersys (ATHX);
Cryo-Cell (OTC BB: CCEL);
Cytori (CYTX);
Dendreon (DNDN);
Geron (GERN);
ImmunoCellular (OTC BB: IMUC);
International Stem cell (OTC BB: ISCO);
Opexa (OPXA);
Osiris (OSIR);
NeoStem (Amex: NBS);
Neuralstem (CUR);
StemCells (STEM);
ThermoGenesis (KOOL);
Verastem (VSTM).

What’s new in the regenerative medicine/stem cell market … Not much … to know today …

British stem cell trial aims to repair children’s livers: http://www.dailymail.co.uk/health/article-2127185/Stem-cell-injections-repair-livers-save-hundreds-lives-year-trial-starts-sick-children.html . Researchers at King’s College Hospital in London will use stem cells derived from the livers of deceased donors to treat rare, life-threatening liver conditions in 18 British children. The cells are designed to repair the children’s damaged livers, and doctors hope the treatment

ThermoGenesis (KOOL) Registration Approval for BioArchive® in China: http://www.scimitarequity.com/blog/2012/04/11/thermogenesis-kool-registration-approval-for-bioarchive-in-china . The Bottom Line: KOOL has established a presence in China with 3leading Chinese stem cell banks as customers. These include Nanshan Memorial Medical Institute, which will be using the BioArchive to store stem cells at its two cord blood stem cell banks in China; BoyaLife, which is currently developing capacity to store more than 1M stem cell units; and Beike Biotechnology Co., Ltd., which operates 3 stand-alone cord blood processing and storage facilities. KOOL is up in early trading, $0.08 <9.52%> to $0.92

Update on VioPharma's Vancocin Capsules; Court Rules Pfizer Can Face Asbestos Suits

Wed, 11 Apr 2012 13:28:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 10, 2012.

ViroPharma Incorporated (Nasdaq: VPHM) announced the U.S. FDA denied the citizen petition (Docket # FDA-2006-P-0007) filed by ViroPharma on March 17, 2006 related to the FDA's proposed in vitro method for determining bioequivalence of abbreviated new drug applications (ANDAs) referencing Vancocin® (vancomycin hydrochloride, USP) Capsules.

In the FDA's response to the citizen petition, the agency denied ViroPharma's citizen petition and also informed the company that a final guidance for vancomycin bioequivalence consistent with the FDA's citizen petition response is forthcoming.

ViroPharma intends to file a complaint in the United States District Court for the District of Columbia, seeking an injunction to set aside the FDA's approval of ANDA's for generic versions of Vancocin. While the courts dismissed ViroPharma's prior lawsuit on the procedural basis of standing, the substance of the company's bioequivalence arguments and the arguments regarding Vancocin's eligibility for exclusivity have not been litigated before the Court.

As it has since 2006, the company will actively pursue a legal remedy in these matters in order to ensure the safety of patients. ViroPharma's efforts to date have already helped make FDA's approval standards for generic vancomycin capsules more patient-protective. FDA's 2006 in vitro bioequivalence method did not protect patients from the risks of inactive ingredient differences, but after ViroPharma filed its petition FDA in 2008 determined that generic products would not be eligible for the in vitro method unless they have the same inactive ingredients in the same quantities as Vancocin. And in yesterday's petition response FDA further tightened the standards to require that generics use a particular grade of polyethylene glycol.

ViroPharma believes that FDA is incorrect in interpreting its bioequivalence regulations in a manner that provides it with broad discretion to permit in vitro bioequivalence testing in the absence of a waiver of in vivo testing. ViroPharma believes that the FDA's position is not supported by its regulations, or by FDA's stated interpretation of those regulations at the time of their enactment.

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A federal appellate court ruled on drugmaker Pfizer (NYSE:PFE) can face asbestos liability suits in state court over products once manufactured by a bankrupt subsidiary, dragging out a dispute that has already lasted more than 30 years.

At issue is insulating products made by Pfizer unit Quigley Co Inc that contained asbestos. Quigley, which Pfizer bought in 1968, at one time faced suits by more than 160,000 plaintiffs. It filed for bankruptcy in 2004.

Pfizer reached a deal that year with lawyers representing more than 80 percent of claimants, which provided for about $430 million in settlement payments. Quigley filed for bankruptcy protection as part of that arrangement, which was aimed at resolving cases dating back to the late 1970s.

The bankruptcy court later ruled that an injunction it issued in the case stayed some suits that were still pending against Pfizer. In May 2011, a federal judge in New York reversed that order, and the U.S. 2nd Circuit Court of Appeals upheld that ruling Tuesday.

Pfizer said in a statement it was evaluating its options.

"It is important to note that the court's ruling is procedural and does not address the merits of the underlying claims, which we strongly dispute," the company said. "In the history of this litigation, Pfizer has never been found derivatively or directly liable for injuries allegedly caused by Quigley's asbestos-containing products."

The suits in question were filed starting in 1999 by plaintiffs lawyer Peter Angelos in Pennsylvania state court. Angelos, one of the best-known asbestos lawyers in the country, also owns the Baltimore Orioles baseball team.

Angelos, according to the 2nd Circuit, had argued Pfizer was liable because the company allowed its label to be put on Quigley's asbestos-contaminated products, and therefore was not covered by the injunction protecting Quigley from lawsuits.

The appellate court ruled that Angelos was correct under the language of what is known as "524(g)," the section of the bankruptcy code that deals specifically with asbestos liability cases.

"We are confident that the Angelos reading of the statutory language at issue here is the correct one," the court's three judges said in the 34-page ruling.

Also Tuesday:

Acorda Therapeutics, Inc. (Nasdaq: ACOR) will host a Research and Development Day for the investment community on Tuesday, April 17, 2012 from 10:00 a.m. to 1:00 p.m. at The Four Seasons Hotel in New York City.

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that Dr. John Rothman, EVP of Science & Operations at Advaxis, and Dr. Robert Petit, VP of Clinical Operations at Advaxis, will present at the World Vaccine Congress 2012 at the Gaylord National Hotel and Convention Center in Washington, DC on April 10-12, 2012.

Akorn, Inc. (NASDAQ: AKRX), a niche specialty pharmaceutical company, today announced that it has launched Vancomycin Hydrochloride USP 125mg and 250mg capsules, the generic version of ViroPharma’s Vancocin®, which is indicated for the treatment of Clostridium difficile-associated diarrhea (CDAD).

ArQule, Inc. (NASDAQ: ARQL) today announced its intention to offer, subject to market and other conditions, 6 million shares of its common stock in an underwritten public offering.

Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that Biovest is seeking marketing approval in Canada for BiovaxID®, its personalized cancer vaccine for the treatment of follicular non-Hodgkin’s lymphoma, an incurable cancer of the immune system.

Enzo Biochem Inc. (NYSE: ENZ) today announced the launch of the ColonSentry™ test for assessing a patient’s risk of having colorectal cancer, the first in a pipeline of new molecular diagnostic products the Company plans for the medical community.

Incyte Corporation (Nasdaq: INCY) announced today that it has scheduled its first quarter 2012 financial results conference call for 8:30 a.m. ET on Thursday, April 26, 2012.

Mallinckrodt, the pharmaceuticals business of Covidien (NYSE: COV), today joined The Partnership at Drugfree.org in supporting the “Wake Up to Medicine Abuse” campaign.

MannKind Corporation (Nasdaq: MNKD), focused on discovering, developing and commercializing treatments for diabetes and cancer, announced today that it will present at the Imperial Capital 2012 Healthcare Investor Forum on Tuesday, April 17, 2012 at 9:00 am Eastern Time at the New York Palace in New York.

Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for its cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices.

The Multiple Myeloma Research Consortium (MMRC) today announced the start of a clinical trial evaluating ganetespib, a second generation Hsp90 inhibitor being developed by Synta Pharmaceuticals (NASDAQ: SNTA), as a single agent and in combination with the proteasome inhibitor bortezomib (VELCADE®) for the treatment of relapsed multiple myeloma.

NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes reported today that it will exhibit at the Midwest Podiatry Conference on April 19-22, 2012 in Chicago.

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announces that data from its Phase 2 study of PV-10 for metastatic melanoma will be presented at the HemOnc Today – Melanoma and Cutaneous Malignancies Conference on April 13, 2012.

Rentech Nitrogen Partners, L.P. (NYSE: RNF) and ClimeCo America Corporation (ClimeCo America) jointly announced today that ClimeCo America will deliver 120,000 Climate Reserve Tonnes (CRT) to Just Energy (NYSE:JE and TSX:JE), a leading competitive North American green energy retailer.

Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, today announced that it expects to receive an additional $5.6 million in proceeds from Eli Lilly and Company’s (NYSE: LLY) acquisition of former partner company Avid Radiopharmaceuticals, Inc., which took place in December 2010.

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported financial results for its second quarter of fiscal year 2012 ended February 29, 2012 (2QFY12).

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has posted information from the MAUDE database showing 377 deaths associated with the Medtronic Quattro Secure lead, rather than the 62 that was reported by Dr. Robert Hauser in a manuscript published online last week by the Heart Rhythm Journal.

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced revised top-line results from its exploratory Phase 2 clinical study of TC-6987 in asthma.

A new Walgreens (NYSE: WAG) (NASDAQ:WAG) study comparing utilization rates of patients filling 90-day prescription medications using community and mail order pharmacies found that when co-pay costs are similar, patients preferred the community pharmacy channel option by a ratio of four to one.

ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that it recently provided an educational grant to sponsor the second annual “Chilling at the Beach─Therapeutic Hypothermia and Temperature Management: Current and Future Directions” conference hosted by the University of Miami Miller School of Medicine.

FDA To Take Another 3 Month Review and Requested an REMS for Vivus's Qnexa Diet Pill

Tue, 10 Apr 2012 13:07:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 9, 2012.

Drugmaker Vivus Inc. (NASDAQ: VVUS) said regulators will take a three month PDUFA extension to make a decision on its closely-watched obesity drug Qnexa, which could become the first new prescription weight loss pill to reach the market in more than a decade.

The FDA informed Vivus that it will decide whether to approve Qnexa by July 17 as it needs more time to review the company's risk evaluation plan for the drug. The previous FDA action date for Qnexa had been April 17.

Vivus's Qnexa is one of three experimental new weight loss drugs seeking FDA approval after initial rejections by the agency. Arena Pharmaceuticals Inc (NASDAQ:ARNA) and Orexigen Therapeutics (NASDAQ:OREX) are also hoping for better news from the FDA after rejections of their diet pills.

After an advisory panel to the FDA in February voted overwhelmingly to recommend approval of Qnexa, saying that its benefits outweighed the risks, hopes that the first new obesity treatment would be approved for sale in the United States in more than a decade soared -- along with Vivus's share price.

But the FDA requested a Risk Evaluation and Mitigation Strategy (REMS) plan from the company, which the agency considers a major amendment to the approval application requiring further review time.

"The Qnexa REMS submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February," Vivus Chief Executive Leland Wilson said in a statement.

"We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans," Wilson added.

Qnexa, which combines the appetite suppressant phentermine and the anti-seizure drug topiramate, helped patients on average lose at least 10 percent of their weight after a year of treatment in pivotal clinical trials.

With about a third of Americans deemed obese and some two thirds classified as overweight, the FDA has been under mounting pressure to approve a new weight loss treatment. But high profile safety problems with past diet drugs and the knowledge that a huge portion of the population will be tempted to take any new diet pills has left the FDA reluctant to approve them.

The FDA could still require Vivus to conduct additional studies to rule out heart problems as it has done with Orexigen's Contrave, or could allow Vivus to conduct such studies after the drug is already on the market.

Vivus shares fell 6.4 percent after the delay was announced, slipping to $21.45 in extended trading from their Nasdaq close at $22.92.

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The U.S. FDA approved Eli Lilly's (NYSE:LLY) radioactive dye, called Amyvid, to help doctors rule out whether patients have Alzheimer's, the most common form of dementia.

The dye binds to clumps of a toxic protein called beta amyloid that accumulates in the brains of patients with Alzheimer's. Doctors can then see the plaque light up on a positron emission tomography, or PET, scan.

Patients with Alzheimer's always have some brain plaque, so its absence in the test would tell doctors to look for other causes of mental decline, such as depression or medications, Lilly has said.

But Lilly, which plans to sell the drug through its unit Avid Radiopharmaceuticals Inc, said the test should not be used to diagnose Alzheimer's, since brain plaque can also be tied to other neurologic conditions and may occur naturally in older people with normal mental states.

An FDA advisory panel recommended against approving the dye last year, saying doctors might have trouble interpreting scans of the plaque, and the FDA rejected Amyvid last March.

There is currently no cure for Alzheimer's, a mind-robbing disease that affects more than 35 million people worldwide and gets worse with age.

But an early hint that something is wrong might improve the success of drugs meant to prevent or delay disease progression, researchers believe.

Avid has been in the lead in the race for imaging agents for Alzheimer's, which are estimated to have a potential global market anywhere from $1 billion to $5 billion.

Lilly, as well as Pfizer Inc, are the farthest along in developing experimental medicines to treat Alzheimer's. Lilly expects to release final data for its contender, solanezumab, as soon as this summer.

Also Monday:

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced that Michael T. Heffernan, R.Ph. has been appointed to the company’s board of directors, effective today.

Affymax, Inc. (Nasdaq: AFFY) today announced that it has received a $50 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize OMONTYS® (peginesatide) Injection.

BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that the Company has sold an additional MicroThermX® Microwave Ablation System (MicroThermX®) to Synapse Medical Ltd. Synapse Medical is a premier specialty distributor of medical devices in Ireland and Northern Ireland, and is an exclusive distributor for a number of leading medical device companies, including BSD. Synapse is a subsidiary of SISK Healthcare, which is part of the SISK Group.

Biogen Idec Inc. (NASDAQ:BIIB) today announced it will report first quarter 2012 financial results on Tuesday, May 1, 2012, before the financial markets open.

Dendreon Corporation (Nasdaq:DNDN) today announced that management will host a conference call on Monday, May 7, 2012, at 4:30 p.m. EDT to review first quarter financial results.

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that a U.S. Food and Drug Administration (FDA) Advisory Panel has proposed a review of the company's Premarket Approval (PMA) application for its Edwards SAPIEN transcatheter heart valve on June 13, 2012.

HemaCare Corporation (OTCBB:HEMA) announced today that it filed a Form 15 with the Securities and Exchange Commission (the “SEC”) to voluntarily deregister its shares of common stock under the Securities Exchange Act of 1934, as amended (the “Act”).

Illumina, Inc. (NASDAQ:ILMN), a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function, today is sending a letter from its Board of Directors highlighting supportive reports issued by two of the nation’s leading proxy advisor firms. Illumina’s Board recommends that stockholders reject Roche’s offer and vote for the election of Illumina’s highly qualified nominees at its 2012 Annual Meeting of Stockholders by completing the WHITE proxy card today.

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ), a developer of real-time medical imaging systems for use in the operating room, today announced the closing of its previously announced public offering of 6,100,000 common shares at a public offering price US$5.75 per share.

Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced the commercial launch of EXPAREL® (bupivacaine liposome injectable suspension) in the United States.

PharMerica Corporation (NYSE: PMC) announced today that it will provide an online simulcast of its first quarter 2012 earnings conference call on Thursday, May 3, 2012.

PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that the Company’s annual meeting of shareholders will be held on Tuesday, June 12, 2012, in Louisville, Kentucky.

Proteonomix, Inc. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today provided updates on its progress.

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) announced today that the Company has received an issued patent in Mexico and allowances of three additional patent applications in Mexico and Israel.

Rodman & Renshaw, LLC, a wholly owned subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ: RODM) announced that it has acted as a Co-Manager for its client Galena Biopharma (NASDAQ: GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, in its underwritten public offering of 8,500,000 shares of its common stock at a public offering price of $1.50 per share.

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of software and consulting services for pharmaceutical R&D and environmental toxicology, announced that it expects to file its quarterly report on Form 10-Q for the second quarter of its 2012 fiscal year, ended February 29, 2012, with the U.S. Securities and Exchange Commission today, Monday, April 9, 2012.

Sunshine Biopharma Inc. (OTCBB: SBFM) is pleased to announce that it has recently received notification that the United States Patent and Trademark Office has issued a “Notice of Allowance” for the patent application covering its lead anti-tumor compound, Adva-27a.

TherapeuticsMD™, Inc. (OTCQB: TXMD), parent company of vitaMedMD®, LLC ("vitaMedMD"), a specialty pharmaceutical company ("TherapeuticsMD" or the "Company"), announced that on April 9, 2012 it launched its second prescription prenatal vitamin, vitaMedMD™ One Rx, following the successful launch of vitaMedMD™ Plus Rx last month.

Verastem, Inc. (NASDAQ: VSTM), a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, announced that the Company will be presenting at the 2012 BD Biotech Conference on Tuesday, April 17 and Wednesday April 18, 2012, at the Mandarin Oriental in Boston, MA.

Q&A: Timothy Mayleben, CEO of Aastrom Biosciences

Mon, 09 Apr 2012 14:14:00 -0400

Last month, Aastrom Biosciences, announced that it had completed an impressive, $40 million private placement financing. The development was noted as a particularly bullish sign for emerging biotechs everywhere.

In an exclusive interview, Timothy M. Mayleben, who has served as Aastrom's President and CEO since late 2009, explains how the financing came together and why investors sought out his firm to place the big bet on their future.

Aastrom Biosciences, Inc.

2.05 +0.02 (+0.99%)

Mayleben, who previously served as an advisor to life science and healthcare companies through his advisory and investment firm, ElMa Advisors, was also formerly the COO of Esperion Therapeutics which later became a division of Pfizer Global Research & Development. He holds an MBA, with distinction, from the J.L. Kellogg Graduate School of Management at Northwestern University and a BBA from the University of Michigan Ross School of Business.

His firm, Aastrom Biosciences, is one of the most exciting regenerative medicine companies in the healthcare sector. They are engaged in the development of autologous cell products for treatment of severe, chronic cardiovascular diseases. Their proprietary cell-processing technology enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a patient's own bone marrow and delivered directly to damaged tissues. The cellular therapy resulting from this process contains expanded populations of mixed stem and progenitor cells to support the regeneration of cardiovascular tissue. The company's cell manufacturing process works exclusively with adult stem cells derived from and administered to the same patient. This approach reduces the risk of rejection and increases the likelihood of integration with the surrounding tissues, eliminating the need for immunosuppressive drugs.

His exclusive interview with BioMedReports appears below:

Big Risk, Big Rewards in Small Cap Biotech

Thu, 05 Apr 2012 11:21:00 -0400

Mark Teper, the managing Partner at Strategic Wealth Partners says there's huge opportunity in the biotech sector. "As wayne gretzky says, you need to skate to where the puck's going, not where it's been," explained Teper in a live interview on CNBC.

"Right now the biggest wave that's in front of us is the biotech sector. There's just a ton of companies out there that are really on the verge of some pretty remarkable breakthroughs when it comes to treating the likes of cancer, heart disease, Alzheimer's.

"These advancements are really going to change our lives over the course of the next several years. What names in particular? If you're looking to hit a home run, stay away from the big boys. Look at really the small cap players. Spectrum Pharmaceuticals. Seattle Genetics. These are all examples of companies that we feel have some pretty good potential as far as the smaller companies go.

Video of Tepper's informative appearance on CNBC appears below:

Using transgenic technology for various applications in humans define Pharming Group NV

Wed, 04 Apr 2012 13:05:00 -0400

Trading on the Euronext, Pharming Group NV (NYSE Euronext: PHARM) produces, purifies and formulates recombinant human proteins using its transgenic technology platform for therapeutic indications in Hereditary Angioedema, Transplant Rejection, Blood Coagulation Disorders and Ischemic Reperfusion Injury.

Pharming Group develops products for various applications in humans. Its product areas include: biopharmaceuticals, biomaterials and bionutritionals. Its product portfolio includes its Rhucinr, a recombinant human C1 esterase inhibitor, is being developed as a replacement therapy for patients who suffer from hereditary angioedema (HAE). Late last month, the company announced that it has entered into an agreement with Hyupjin Corporation, to commercialize RUCONEST for the treatment of acute attacks of Hereditary Angioedema (HAE) in the Republic of Korea. The firm’s innovative therapeutics for the treatment of genetic disorders and ageing diseases, as well as specialty products for surgical indications, and intermediates for nutritional products and a variety of other applications are preparing to enter humans after some impressive results in pre-clinical studies. Despite being early in their development pipeline, they have several partnerships and collaborations with Swedish Orphan Biovitrum AB, GTC Biotherapeutics Inc, AgResearch, Eczacibasi Ilac, Pazarlama, Esteve, NovaThera, Schering-Plough, Aslan, and even the US Army.

Sijmen de Vries, the Chief Executive Officer of the company recently sat down with BioMedReports to discuss the frim's truly innovative technology platform which involves a recombinant human C1 esterase inhibitor obtained from the milk of transgenic rabbits.

Dr de Vries, MD MBA, is responsible for the overall management of the company- which is still early in their development process. Dr de Vries has extensive senior level experience in both the pharmaceutical and biotechnology industries. He joins Pharming from Swiss-based 4-Antibody where he was CEO. Dr de Vries has also been CEO of Morphochem and prior to this spent many years at Novartis and at SmithKline Beecham Pharmaceuticals where he held senior business and commercial positions. Dr de Vries also holds non-executive directorships in two private life science companies. Dr de Vries holds a Medical Degree from the University of Amsterdam and a MBA in General Management from Ashridge Management College (UK).

FDA Approves Levemir® for Women with Diabetes; Keryx Announces Top-Line Data from the Perifosine

Tue, 03 Apr 2012 12:41:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 2, 2012.

Novo Nordisk (NYSE:NVO), a world leader in diabetes care, announced the U.S. FDA has approved Levemir® (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification, indicating that Levemir®, when used in pregnant women with diabetes, did not increase the risk of harm to the unborn baby.

The label update makes Levemir® the first and only basal insulin analog to have this classification. Until this decision, NPH (human insulin) was considered the standard of care for diabetes in pregnancy. Now, Novo Nordisk is the only company that offers a complete portfolio of insulin analogs with a pregnancy Category B classification.

The FDA category change was based on a review of a large, randomized controlled trial examining Levemir® in pregnant women with type 1 diabetes. The study compared the safety and efficacy of Levemir® against NPH insulin in the treatment of 310 women. The study found that patients taking Levemir® had similar A1C reduction at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 compared with NPH. Additionally, the study found no differences in the overall safety profile during pregnancy, on pregnancy outcomes or the health of the fetus and newborn.

"We are excited that the FDA has granted approval for this new category rating for Levemir®," said Lois Jovanovič, MD, MACE, Chief Scientific Officer, Sansum Diabetes Research Institute in Santa Barbara, California. "For women who are pregnant, diabetes can be extremely challenging; they must be even more diligent and careful when monitoring blood sugar levels than before they were pregnant. This approval provides patients with a long-acting insulin analog option that can help them manage their blood sugar.”

In the U.S., there are approximately 1.85 million women of child-bearing age with diabetes. For those who want to get pregnant, this development gives them another option to manage their diabetes.

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Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) reported the Phase 3 "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine (KRX-0401) + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo.

This Phase 3 trial was conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. 468 patients at sixty-five U.S. sites participated in this study.

Ron Bentsur, Chief Executive Officer of Keryx, stated, "We are all extremely disappointed with the results of the study. We thank the investigators who participated in what we believe was a well-run study, despite the outcome. We will evaluate whether our Phase 3 study of Perifosine in relapsed/refractory multiple myeloma will continue as planned."

Mr. Bentsur commented further, "With approximately $31 million in cash as of March 31, 2012, and a well-controlled burn rate, we plan to focus our resources on the pending completion of the Zerenex (ferric citrate) long-term Phase 3 study for end stage renal disease (ESRD) patients with hyperphosphatemia, expected in the fourth quarter of 2012, and the New Drug Application (NDA) filing for Zerenex which will hopefully follow shortly thereafter."

Also Monday:

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the launch of a new interactive patient website called Ampyra Journeys (www.AmpyraJourneys.com).

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the presentation of new preclinical data on its investigational pan-BCR-ABL inhibitor, ponatinib, and its investigational dual EGFR-ALK inhibitor, AP26113, at the American Association for Cancer Research Annual Meeting in Chicago.

Astro-Med, Inc. (NASDAQ: ALOT), a world leader in the data acquisition and recording market, today introduced its new TMX®-18 High-Speed Data Acquisition System, offering best in class efficiency for general purpose data capture, review, archive, and analysis.

Bristol-Myers Squibb Company (NYSE:BMY) will announce results for the first quarter of 2012 on Thursday, April 26, 2012.

Cannabis Science, Inc. (OTCBB: CBIS) a pioneering U.S. biotech company developing cannabis pharmaceutical and over the counter nutraceutical products, is pleased to report it is moving forward with its FDA IND process.

Citadel EFT, Inc. (OTCQB: CDFT) (PINKSHEETS: CDFT), which offers U.S. merchants credit card terminals, online services, mail order and retail credit card processing services, announces today that it has signed on merchant credit card services for Buypureomega.com.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) will issue its first quarter 2012 financial results at 4:00 p.m. ET on Wednesday, April 18th, 2012.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care announced today that Edward J. Quilty, the Company’s chief executive officer will present a corporate overview and update at the 11th Annual Needham Healthcare Conference taking place from April 3-4, 2012 at The New York Palace Hotel, New York City.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced the pricing of an underwritten registered direct offering of 2,125,000 shares of common stock at a price of $9.25 per share.

EasyMed Services Inc. (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6) ("ESI") is pleased to announce today that it has entered into a letter of intent dated April 1, 2012 (the "Letter of Intent") with Biosign Technologies Inc. (TSX VENTURE:BIO) ("Biosign") to complete a business combination (the "Transaction").

Exelixis, Inc. (NASDAQ:EXEL) announced today that its lead compound, cabozantinib, will be the subject of nine separate data presentations at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO).

Fibrocell Science, Inc. (OTCBB: FCSC), an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications, announced today that it has rescheduled its fourth quarter 2011 business update investor conference call to Tuesday, April 3, 2012 at 8:00 AM Eastern Time.

Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, will release its Fiscal 2012 Fourth Quarter financial results before the U.S. stock market opens on Tuesday, April 17, 2012.

Health Net, Inc. (NYSE:HNT) today announced that its subsidiary, Health Net Life Insurance Company, completed the sale of its Medicare stand-alone Prescription Drug Plan (Medicare PDP) business to a subsidiary of CVS Caremark (NYSE:CVS).

Illumina, Inc. (NASDAQ:ILMN) today announced estimated first quarter revenue of approximately $270 million.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today presented new preclinical data for saridegib (IPI-926), its novel oral molecule that inhibits Smoothened, a key component of the Hedgehog pathway.

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that data from the pivotal Phase III study with ZOSTAVAX® (Zoster Vaccine Live) in adults ages 50 to 59 were published in the April 1 issue of Clinical Infectious Diseases.

NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that its previously announced pre-IND Meeting was held with the USFDA on March 29th, 2012, as scheduled.

Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF) ("Stellar" or "the Company"), an emerging specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada, today announced financial results for the year ended December 31, 2011.

Synageva BioPharma Corp. (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, announced today an expansion of its previous collaboration with Mitsubishi Tanabe Pharma Corporation (Head Office; Osaka, Japan, “MTPC”) to develop a second protein therapeutic for an undisclosed orphan disease using Synageva’s product development capabilities and proprietary protein expression platform.

Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) ("Teva") announced today that it successfully priced its debut EUR 1 billion and CHF 450 million debt offerings, and that it entered into a JPY 100 billion (approximately USD 1.2 billion) senior unsecured fixed-rate syndicated term loan facility.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it has commenced commercial launch of both Irbesartan and Irbesartan-Hydrochlorothiazide Tablets, the Company’s generic versions of Sanofi Aventis’ high blood pressure treatments, Avapro® and Avalide® Tablets.

Walgreens (NYSE: WAG) (NASDAQ: WAG) and the Magic Johnson Foundation today announced a national campaign to address the health, educational and social needs of ethnically diverse, urban communities.

Co-founder of biotech powerhouse, ImClone Systems, sees perhaps even greater potential at Neptune subsidiary

Mon, 02 Apr 2012 15:37:00 -0400

Two of our favorite biotech companies are tied at the hip, but one of them does not yet trade in the U.S. With a key upcoming catalyst that could see big pharma lining up with partnership offers, is there a way for American traders and investors to get skin in the game?

Neptune Technologies & Bioressources (NASDAQ:NEPT) and its share holders own a significant portion of their Canadian spin-off, Acasti Pharma Inc.(TSX-V.APO) which-- at least for the time being-- trades only on the Toronto Stock Exchange.

Neptune Technologies & Bioresources, Inc.

3.10 -0.05 (-1.59%)

2.10 - (0.00%)

A year or so ago, we first covered the Nasdaq traded Neptune when its shares were trading around the $2 mark. The stock rose significantly shortly after our reports-- due mostly to the fact that the stock had such a low float and was mostly undiscovered. Still, like so many other biotechs its shares now appear significantly undervalued (for a number of reasons which we will get into in more detail during an upcoming report). While Neptune is easily two times the company it was when we first covered it, the market has not yet recognized or appreciated some of the firm's recent fundamental changes, milestone accomplishments and its position for greater profitability than ever.

Even while most American investors can't buy stock in Acasti Pharma, that foreign exchange listed subsidiary has some important upcoming catalysts that could add significant value to both stocks.

In short, the key takeaway here is that as Acasti rises, so will Neptune.

Harlan Waksal M.D. quitely joined Acasti Pharma, the first subsidiary of Neptune Technologies & Bioressources as Executive Vice-President, Business & Scientific Affairs last summer.

Waksal, who helped found and eventually right the sails at ImClone Systems-- a powerhouse biotech (and now a wholly-owned subsidiary of Eli Lilly and Company)-- sees the same potential at Neptune’s subsidiary Acasti Pharma.When he first saw the effects of the parent company’s Phospholipid Omega 3 Krill Oil first hand as a patient, he excitedly recognized the promise and market potential of their highly patented platform.

When he saw the effects of the parent company’s Phospholipid Omega 3 Krill Oil first hand as a patient, he excitedly recognized the promise and market potential of their highly patented platform.

"I did get excited about it," explains Waksal. "It was very clear that Neptune had a potential product in the area of cardiovascular, that I thought was not only unique, but something that could be a billion dollar type of product."
"Why was that exciting for me? It is rare that somebody comes across a potential drug that has a safety profile that is already well understood. We're working with something called the Phospholipid Omega 3 coming from Krill- a small crustacean that we fish from Antarctica.”

In an exclusive video interview with BioMedReports, Waksal answers questions about the key characteristics which make both companies an intriguing bet for biotech investors- particularly with data from Phase II clinical trials expected during the second half of 2012.

“We're focusing on triglycerides, and that is a little different than the whole lipid profile, statins are addressing a different aspect,” Explains Dr. Waksal. They're addressing the bad cholesterol, the LDL. The market for the statins is about $35 billion. For fish oils it's very different.

“The overall fish oil market for 2012 will be somewhere around $8 billion. Of that $8 billion, however, you have to break down what is the prescription aspect of that. And the prescription market is $1.3 billion for one prescription drug, Lovaza (Omega-3-acid Ethyl Esters)-- the fish oil. That's how much it comprises. So this is an area that is growing and changing and will continue to evolve.

“My personal feeling about this is that we're in the midst of an epidemic. An epidemic with obesity, with fast food, with diabetes, and this is a growing and growing area because of the mean implication of those things is an increase of triglycerides and drugs that can counter that are going to be increasingly desired because the ramification of having triglyceridemia is having coronary artery disease. And if we can do things to go ahead and stop that, that's a great thing. My belief is, beyond the fish oils, that our drug will have an ability to be taken at a lower dose, have greater implications in terms of its ability to be tighter to a patient's need because you're going to be able to go to a higher does; won't require being taken with any kind of food or fats like the current drugs that our out there. And I think that, overall, this market area is going to grow very dramatically. And so, I believe that we have the potential of having, what I consider, a blockbuster-type of drug that could be greater than a billion dollars in value.

“I've already built a biotech company and I understand the hyperbole that goes with that, and fortunately we were very successful in bringing into fruition what we believed would take place-- a breakthrough type of technology.
“In this case, it's a little bit of lower hanging fruit. We know what the technology should do. We know what Omega 3's should do. What we need to prove is that the Phospholipid Omega 3 has greater potential than the other drugs that are out there, that are doing the same kind of thing-- like the other Omega 3's. So to me, everything comes down to data. We are doing the clinical studies now. This is the year that we're going to be generating that data and I'm very excited about it and looking forward to it because I believe the data is going to demonstrate the kind of potential this drug is going to have.

“We have one marketed product that uses the same technology that products in our pipeline are using. It’s approved. It’s been through the FDA and it serves as a great proof-of-concept for our ability to not only take our product through the regulatory pathway, but also partner and get through commercialization."

Sunesis and Royalty Pharma Announce Agreement; Forest Labs and Almirall Announce Extended Review Period

Fri, 30 Mar 2012 14:19:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on March 29, 2012.

Sunesis Pharmaceuticals (Nasdaq:SNSS) and Royalty Pharma announced Royalty Pharma has agreed to pay Sunesis $25 million, under certain circumstances related to the successful development of Sunesis' lead product candidate vosaroxin, to acquire a royalty on future worldwide net sales of vosaroxin.

Sunesis is evaluating vosaroxin in a pivotal Phase 3, randomized, double-blind, placebo-controlled trial, the VALOR trial, in patients with first relapsed or refractory acute myeloid leukemia (AML). The VALOR trial employs an adaptive trial design that permits a one-time increase in sample size at the interim analysis by its Data and Safety Monitoring Board (DSMB). At the interim analysis, expected in the third quarter of 2012, the DSMB will examine pre-specified efficacy and safety data sets and decide whether to stop the study early for efficacy or futility, continue the study as planned or implement a one-time sample size adjustment of 225 additional evaluable patients.

Under terms of the agreement, Royalty Pharma will invest $25 million immediately following VALOR's interim analysis if: (a) the study stops early for efficacy, in exchange for a 3.6% participation payment on future net sales; or (b) the one-time sample size increase is being implemented, in exchange for a 6.75% participation payment on future net sales as well as two warrants. In the case when VALOR proceeds to its planned 450 patient enrollment, Royalty Pharma has the option to make a $25 million investment upon the unblinding of the study in exchange for a 3.6% participation payment on future net sales. The warrants issued to Royalty Pharma are exercisable if VALOR's sample size is increased and are each to purchase 1,000,000 shares of Sunesis common stock at an exercise price of $3.48 and $4.64 per share, respectively. Sunesis currently holds all worldwide commercial rights to its vosaroxin product.

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Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM.MC) announced the U.S. FDA will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). No additional data has been requested by the agency to complete the review. FDA action is now expected by July 2012.

This FDA notification follows the Pulmonary-Allergy Drugs Advisory Committee (PADAC) February 2012 meeting during which the committee endorsed the efficacy and safety of twice-daily aclidinium bromide 400ug with a positive 12 to 2 vote in favor of approval.

The efficacy and safety of aclidinium was studied in a clinical trial program including 2,717 COPD patients in 9 studies. In these trials, aclidinium demonstrated significant improvement in lung function, with a low incidence of side effects, comparable to placebo.

Also Thursday:

Affymetrix, Inc. (NASDAQ:AFFX) today announced that it has signed a global distribution agreement with Almac Group Ltd., an established company that provides an extensive range of pharmaceutical services.

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced data from a Phase 2 study of asfotase alfa in adolescents and adults with hypophosphatasia (HPP), a severe and ultra-rare metabolic disorder.

The team at AirWare Labs (OTCBB: CDYY) has completed the product development for their drug-free, break-through technology-based Product, AIR.

ArQule, Inc. (Nasdaq: ARQL) today announced eight presentations of clinical and pre-clinical data for tivantinib (ARQ 197) at the Annual Meeting of the American Association for Cancer Research (AACR), held from March 31 – April 4 in Chicago, Illinois.

Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced the acceptance of fourteen abstracts for presentation at the American Association for Cancer Research (AACR) 2012 Annual Meeting.

AstraZeneca (NYSE: AZN) today announced that the US District Court for the District of New Jersey has found the formulation patent protecting SEROQUEL XR® (quetiapine fumarate) extended release tablets to be valid.

Bio-Path Holdings, Inc., (OTCBB: BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced that it has entered into a services agreement with Los Angeles-based investor relations firm PondelWilkinson to assist the Company in implementing an investor and public relations program geared to the individual retail investment community.

BrainStorm Cell Therapeutics (OTCBB: BCLI), a developer of adult stem cell technologies and CNS therapeutics, has issued a CEO update to shareholders and investors, with a review of recent accomplishments.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today reported financial and operating results for the three and 12 months ended December 31, 2011.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, announces the signing of a definitive agreement to acquire MedEfficiency, Inc. (“MedEfficiency”), manufacturer of the TCC-EZ™ Total Contact Cast system, for $14.5 million in cash.

GenMark Diagnostics, Inc. (NASDAQ: GNMK), announced today that it has entered into a license agreement with PerkinElmer, granting GenMark a non-exclusive license under PerkinElmer’s microfluidics patent portfolio.

GenSpera, Inc. (OTCBB:GNSZ) announced the successful completion of the dose-escalation component in the ongoing Phase I trial of its lead chemotherapeutic agent, G-202.

Genzyme, (EURONEXT: SAN and NYSE: SNY), a Sanofi company and Isis Pharmaceuticals Inc. (NASDAQ: ISIS), announced today that new two-year data from a phase 3 long-term extension study of KYNAMROTM (mipomersen sodium) were presented at the XVI International Symposium on Atherosclerosis in Sydney, Australia.

Hercules Technology Growth Capital, Inc. (NASDAQ: HTGC), a leader in customized debt financing for entrepreneurial venture capital and private equity-backed companies in technology-related markets including cleantech and life science, announced today they have appointed Jessica Baron to permanently serve as the Company’s chief financial officer effective immediately.

Idera Pharmaceuticals, (NASDAQ: IDRA) a biotechnology company developing novel therapeutics for autoimmune diseases and cancer, today announced that it will present at the 11th Annual Needham Healthcare Conference on Wednesday, April 4th 2012, at 4:00 pm EST at the New York Palace Hotel in New York City, NY.

Interleukin Genetics, Inc. (OTCQB: ILIU) today issued financial and operational results for its fiscal fourth quarter and full fiscal year ended December 31, 2011.

MMRGlobal, Inc. (OTCBB: MMRF), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, plans on filing its 2011 Annual Report on Form 10-K for the period ended December 31, 2011 with the U.S. Securities and Exchange Commission on Friday, March 30, 2012 after the close of market.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB) today announced that Dr. Thomas Tulip, Executive Vice President and Chief Business Officer, will participate at the 11th Annual Needham Healthcare Conference on April 3 - 4 at the New York Palace Hotel in New York City.

Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced that Cooper Collins, President and Chief Executive Officer, will present at the 11th Annual Needham Healthcare Conference on Tuesday, April 3, 2012 at 10:40 a.m. EST.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has increased its offer price for all outstanding publicly-held shares of Illumina, Inc. (NASDAQ: ILMN) to US$ 51.00 per share in cash.

Seattle Genetics, Inc. (NASDAQ:SGEN) announced today that management will present at the upcoming 11th Annual Needham Healthcare Conference in New York, NY. The presentation is scheduled for Tuesday, April 3, at 10:00 a.m. Eastern time.

Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today that it will host a joint symposium on Body Shaping featuring its VelaShape body contouring system and the recently acquired UltraShape focused ultrasound fat lipolysis system at the 2012 Anti-Aging Medicine World Congress & Medispa Conference in Monte Carlo.

Take Care Health Systems, a wholly-owned subsidiary of Walgreens (NYSE: WAG) (NASDAQ: WAG), and Tufts Health Plan today announced the opening of a workplace health center called the BeWell Center, offering wellness and preventive care, symptom care, and laboratory services to Tufts Health Plan employees and contractors.

University General Health System, Inc. (OTCQB: UGHS) (PINKSHEETS: UGHS), a diversified, integrated multi-specialty health delivery system, today announced that its flagship Houston-based University General Hospital has been named a Blue Distinction Center for Bariatric Surgery® by Blue Cross and Blue Shield of Texas for demonstrating better overall quality of care and patient results in bariatric surgery.

VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (PINKSHEETS:VPTDF) is pleased to announce that it has received CE Approval for the Company's new Pulmonary Arterial Hypertension (PAH) application for the VentriPoint Medical System™ (VMS™).

Vermillion Receives Notice of Allowance; Allergan Announces Positive Top-Line Results from Phase III BOTOX®

Thu, 29 Mar 2012 14:06:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on March 28, 2012.

Vermillion, Inc. (NASDAQ:VRML), a leading molecular diagnostics company, has received a notice of allowance from the United States Patent and Trademark Office for a patent, "Methods for Diagnosing Ovarian Cancer."

This patent further expands the list of biomarkers Vermillion has employed in the diagnosis or status determination of ovarian cancer. In this case, the granted claims cover the use of Protein C Inhibitor (PCI) in ovarian cancer tests using blood and several other sample types.

"Vermillion continues to expand its already extensive portfolio of biomarker-related patents in ovarian cancer and other important disease states," said Donald Munroe, Ph.D., chief science officer and VP of research & development at Vermillion. "The latest patent allowance further strengthens the ovarian cancer franchise behind our lead product, OVA1®, and offers creative new options to detect and manage this silent killer."

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Allergan, Inc. (NYSE: AGN) announced two Phase III clinical trials of BOTOX® (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Results from both Phase III clinical trials demonstrate that BOTOX® significantly reduced urinary incontinence (bladder leakage) episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment. The summary data are being presented as part of Allergans Research and Development Technology Review, which will be held today at 1 p.m. Eastern Time. The full study results of the North American Phase III study are expected to be presented at an upcoming medical meeting.

Based on the results of the two Phase III clinical trials, Allergan (AGN) has submitted a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) and an application with European Regulatory authorities seeking approval for the use of BOTOX® as treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. BOTOX® is currently approved in the United States and in several European countries for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Allergan is committed to the research and clinical development of novel treatment options for urologists and their patients, and we look forward to potentially expanding the use of BOTOX® as a treatment option following approval by the respective regulatory agencies, said Scott Whitcup, M.D., Allergans Executive Vice President, Research and Development, Chief Scientific Officer. We are pleased with the results of our idiopathic overactive bladder Phase III clinical trials, which demonstrated that BOTOX® treatment provided benefit to these overactive bladder patients with symptoms of urinary incontinence who failed or were intolerant of other therapy.

Both Phase III clinical trials included patients with symptoms of OAB not caused by a neurological condition who were suffering with urinary incontinence for at least six months and who were inadequately treated with an anticholinergic therapy. Patients were randomly assigned to treatment with BOTOX® or placebo injections into the detrusor (bladder) muscle, followed by an injection with BOTOX® after a minimum of 12 weeks if desired. In both studies, there was a highly statistically significant decrease in the number of daily incontinence episodes in patients treated with BOTOX® vs. placebo (p<0.001).

In both Phase III clinical trials, BOTOX® treatments were well tolerated in patients suffering from OAB symptoms with urinary incontinence. Adverse events were primarily limited to the urinary tract, with urinary tract infection rates between 15-20 percent and urinary retention rates between 5-6 percent for patients treated with BOTOX® in both studies. Patients receiving BOTOX® treatments in both studies also reported an improvement in quality of life.

Also Wednesday:

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will present at the 11th Annual Needham Healthcare Conference on Tuesday, April 3, 2012, at 9:20 a.m. Eastern Time at The New York Palace Hotel in New York City.

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that two abstracts have been selected for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2012 in Chicago, IL, from March 31-April 4.

Allergan, Inc. (NYSE: AGN) today announced that two Phase III clinical trials of BOTOX® (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Results from both Phase III clinical trials demonstrate that BOTOX® significantly reduced urinary incontinence (bladder leakage) episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment.

Antares Pharma, Inc. (NYSE Amex: AIS) today announced that Robert F. Apple, Executive Vice President, Chief Financial Officer, and President of the Parenteral Products Division, will present at the 11th Annual Needham Healthcare Conference Wednesday, April 4, 2012 at 1:20 pm ET (Eastern Time).

ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the 11th Annual Needham Healthcare Conference on April 4, 2012 at 11:20 a.m.

Mark A. Sirgo is the President and CEO of BioDelivery Sciences International, Inc. (NASDAQ: BDSI).

BioLineRx Ltd. (NASDAQ:BLRX) (TASE:BLRX), a biopharmaceutical development company, today announced that its Chief Financial and Operating Officer, Philip Serlin, and its Vice President of Research and Development, Leah Klapper, Ph.D., will be presenting at the 2012 Annual Needham Healthcare Conference at the New York Palace Hotel in New York.

Bristol-Myers Squibb Company (NYSE:BMY) and Meso Scale Discovery today announced they have entered an agreement to develop diagnostic assays that will measure cerebrospinal fluid biomarkers for use in Alzheimer’s disease research.

Clovis Oncology, Inc. (Nasdaq: CLVS) announced today that the first clinical study of CO-1686 has commenced with the dosing of the first patient at a U.S. study site.

Compugen Ltd. (NASDAQ: CGEN) announced today the establishment of operations in South San Francisco, California for the development of oncology and immunology monoclonal antibody (mAb) drug candidates against Compugen-discovered targets.

EP Global Communications, Inc., (PINKSHEETS: EPGL), is pleased to announce that it has reached a restructuring agreement with the liquidator of AJW funds to convert 100% of the Company's debt into equity and restructure the Company into a medical device manufacturer, subject to shareholder approval.

Galectin Therapeutics Inc. (NASDAQ: GALT, GALTU, GALTW) today announced it has closed its underwritten public offering of 1,333,361 units (including 173,916 units that were offered and sold by Galectin pursuant to the exercise in-full of the underwriter’s over-allotment option) at a price to the public of $9.00 per unit, with each unit consisting of two common voting shares, par value $0.001 per share (the “Common Stock”) and one warrant to purchase one share of Common Stock.

Helix BioMedix, Inc. (OTCQB: HXBM), a developer of bioactive peptides, today announced financial results for the year ended December 31, 2011.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be presenting at the Needham 11th Annual Health Care Conference on Wednesday, April 4, 2012, in New York.

Mentor Capital, Inc. (PINKSHEETS: MNTR) will hold its annual shareholders' meeting at the company offices outside of San Diego, April 29, 2012 at 10:00AM.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the appointment of Michael J. Holston as chief ethics and compliance officer effective June 25, 2012.

Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on developing clean, sustainable solutions for plastics, chemicals and energy, today announced that it has appointed Stephen J. Large to its board of directors.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB), a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its Phase 3 clinical study investigating 99m-Tc-Tilmanocept (Lymphoseek®) in oral and squamous cell cancers (SCC) were presented as a poster presentation at the 65th Annual Cancer Symposium of the Society of Surgical Oncology (SSO) meeting held in Orlando, Florida, March 21-24, 2012.

Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced financial results for the quarter and year ended December 31, 2011.

Proteonomix, Inc. (OTCBB: PROT) updated the progress of its cosmeceutical business operated by its Proteoderm, Inc, subsidiary under the guidance of recently appointed CEO Jaci Mandil.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has commenced commercial launch of Quetiapine Fumarate Tablets, the Company’s generic version of AstraZeneca’s schizophrenia treatment, Seroquel® Tablets.

Video Q&A: Mark A. Sirgo, President and CEO of BioDelivery Sciences

Wed, 28 Mar 2012 11:46:00 -0400

After spending more than 20 years in the pharmaceutical industry with companies like GlaxoSmithKline and others, Mark A. Sirgo joined BioDelivery Sciences (Nasdaq:BDSI) in August 2004 as Senior Vice President of Commercialization and Corporate Development upon the acquisition of Arius Pharmaceuticals-- a company which he co-founded.

BioDelivery Sciences Internati

2.31 -0.02 (-0.86%)

Today, in an exclusive, video interview with BioMedReports, Sirgo answers questions about BioDelivery’s platform, partners and unique pipeline products. In addition, he tells investors about some of the key characteristics which set BDSI apart in the market.

“The two products in our pipeline have much greater value than our first product, “explains Dr. Sirgo. “We’ve demonstrated the ability to move products through the regulatory hurdles. Investors need to take a closer look at our pipeline and the value that we plan to create there.”

“We have one marketed product that uses the same technology that products in our pipeline are using. It’s approved. It’s been through the FDA and it serves as a great proof-of-concept for our ability to not only take our product through the regulatory pathway, but also partner and get through commercialization."

BioDelivery Sciences utilizes patented and proprietary drug delivery technologies to create products and formulations that meet important patient and healthcare provider needs. Its drug delivery technologies include: Bioral® and Bema®. The company's Bema® drug delivery technology consists of a small bioerodible polymer film for application to mucosal membranes (inner lining of cheek) for delivering a dose of drug across the mucous membranes for time sensitive conditions or to facilitate administration of drugs with poor oral (pill) absorption. Its Bioral® drug delivery technology encapsulates and protects the drug without chemically bonding to it and may facilitate oral dosing of drugs that typically need to be given by intravenous administration.

Our BioMedReports FDA Calendar and Clinical Trials Tracker shows that BDSI plans to initiate their BEMA Buprenorphine/Naloxone pivotal pharmacokinetic study and the safety study by mid-2012. Results of the pivotal pharmacokinetic study are anticipated to be available within three months of initiation and the safety study by early 2013 and that this will allow for an anticipated NDA filing in the first half of 2013. In addition, there are other key milestones which investors should be looking for involving the initiation of two Phase III studies in the third quarter of 2012.

BioDelivery Sciences' products include: Onsolis® indicated for the treatment of breakthrough cancer pain; Bema® Buprenorphine indicated for the treatment of moderate to severe chronic pain; Bema® Triptan indicated for the treatment of migraine; Bema® Buprenorphine/Naloxone indicated for the treatment of opioid dependence; Bema® Granisetron indicated for the prevention of nausea and vomiting associated with cancer therapies, etc.

The past fifteen months have been very exciting for BDSI as they have made significant progress in prudently deploying their resources and moving their company forward. Share are currently trading at a discount; -42.47 % from their 52-Wk High ($4.05) and there is very small short interest in the stock.

FDA Rejects MAP Pharmaceuticals' Migrane Drug Candidate

Tue, 27 Mar 2012 12:34:00 -0400

The FDA has asked drugmaker MAP Pharmaceuticals (NASDAQ:MAPP) to address issues tied to chemistry, manufacturing and controls before it can decide whether to approve its potential migraine treatment Levadex. The company's shares dropped dramatically in premarket trading onTuesday.

Traders will be watching the trading action closely and MAPP becomes a good candidate for a "dead cat bounce" play as retail investors appear to be over- reacting to the news.

MAP Pharmaceuticals, Inc.

16.65 -0.49 (-2.85%)

Regulators told the Mountain View, Calif., company in a letter that they have not finished their review of inhaler usability information, which was requested late in the FDA's review cycle. The FDA also asked MAP to address "observations from a recent facility inspection of a third party manufacturer," MAP said in a statement released Monday after markets closed.

The drugmaker said it will work with the FDA to address issues raised in the letter as quickly as possible. The company noted that regulators did not ask for additional studies and did not cite any potential safety issues or concerns about effectiveness.

"We believe the core issue was the inability of the FDA to complete the review of a last minute request for information on inhaler usability," Wedbush Securities analysts Liana Moussatos and Richard Lau wrote in a note to clients.

Analysts at J.P. Morgan said that while they expect the shares to trade lower as the key positive catalyst for the stock has now been delayed, they continue to view Levadex as a $500 million peak sales product.

Both the brokerages said that issues related to manufacturing appear manageable and can be easily corrected.

"We anticipate Map should be able to complete requirements associated with CMC and correcting observations ... within three months and resubmit the (New Drug Application) in the third quarter," Wedbush analysts said.

"With a rapid review, approval could occur by year-end."

The FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval. The Company is pleased with the FDA-provided revisions to product labeling and packaging, including correct use of the LEVADEX trade name.

Other migraine therapies currently available in market include Pozen Inc's (NMQ:POZN - News) Trexmet, AstraZeneca's (LSE:AZN.L - News) Zomig and Zogenix Inc's (NMQ:ZGNX - News) SUMAVEL DosePro.

MAP is working with Allergan Inc. to develop Levadex as an inhaled migraine treatment for adults, and the companies will share profits on sales of the drug if it is approved.

MAP said last August that the FDA had accepted its marketing application for Levadex, which triggered a $20 million payment from Allergan.

Chance to discover and help fund top innovators in healthcare early intrigues investors

Fri, 23 Mar 2012 12:47:00 -0400

They may be some of the most talked about market movers today, but companies like Alimera Sciences (Nasdaq:ALIM), Pozen (Nasdaq:POZN), Threshold Pharmaceuticals (Nasadq: THLD), Arena Pharmaceuticals (Nasdaq:ARNA) and others were once only ideas looking for early investors to back and believe in them. While their technologies were eventually recognized as some of the most compelling and propelled to the public markets, each of their journeys is unique and fascinating to hear.

Next week, the next generation of future market movers-- some of the hottest early stage and emerging growth life sciences, healthcare and biotech innovators will be presenting live to investors who are looking to connect with entreprenuers.

BioMedReports is, once again, a proud sponsor of this year's Life Sciences and Healthcare Venture Summit presented by youngStartup Ventures.

The event is on tap for next week, March 28th in New York City and it has certainly earned its place as the premier industry gathering connecting venture capitalists, corporate VCs, angel investors, technology transfer professionals, senior executives of early stage and emerging growth companies, university researchers, incubators and premier service providers.

Whether you are an investor seeking access to new early stage deals, or a CEO or Founder of a new venture looking for funding, visibility and growth, the Life Sciences and Healthcare Venture Summit is the one event you don't want to miss. While crowdfunding is the rage right now in the angel community, investors still need top innovations and great companies to bring to the public markets.

Joe Benjamin, who has been helping to organize and present the summit for eight years says this venture summit is important to investors. "It offers access to quality deals," explains Benjamin. "It's also a great opportunity to network with fellow investors and see early stage and emerging growth biotech,pharma, med device, diagnostics, healthcare and healthcare IT startups."

Benjamin says they are expecting 70 companies who will be presenting. If you're a company interested in pitching your platform or idea, you'll have to wait until next year since there are no more slots available.

There are still some limited spots for investors, however.

BioMedReports readers who are interested in registering for the event may use the code "biomedreports" to sign up at discount of $150 off the current rates.

You must act fast, however, since late and on-site registrations are priced significantly higher.

Those wishing to take advantage of the opprotunity to access all of the plenary sessions and panels, get involved in networking sessions and access CEOs and Top Innovator presentations may do so at:
https://s74201.gridserver.com/registration/?ysveid=155
We look forward to seeing you there.

J&J Marketed Mesh Implant Without U.S. Approval; Align Announces Shareholder Lawsuit Dismissed

Thu, 22 Mar 2012 13:18:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on March 21, 2012.

Johnson & Johnson (NYSE:JNJ) sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them.

J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.
Enlarge image J&J Sold Vaginal Mesh Implant Without Regulatory Approval

Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.

The company, the world’s second-biggest health-care products maker, said it could market the Prolift without approval because it was so similar to an approved device, the Gynecare Gynemesh, Morgan Liscinsky, an FDA spokeswoman, said in a March 16 e-mail. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.

J&J’s unauthorized sales might cost it more to resolve lawsuits over the product. J&J already has endured recalls of artificial hip implants and over-the-counter drugs. Three J&J units have pleaded guilty in the past two years to bribery or illegal marketing of drugs. A fourth agreed to plead guilty in a marketing case.

“They were initially able to put the Prolift on the market without even telling the FDA,” said attorney Adam Slater, who is suing J&J on behalf of more than 100 women. “Even though Johnson & Johnson supposedly lives by a credo to put the patient first, this is an example of fast-tracking a product to market quickly rather than going to the FDA first.”

The conduct by Ethicon also raises questions about the FDA’s approval process, which lets companies introduce products without human testing if the agency decides they’re similar to devices already for sale, or so-called predicates.

Congress has been pushing for changes to the system in response to industry complaints about slow reviews and inconsistent standards. The FDA also has faced criticism after high-profile recalls, including J&J’s withdrawal in 2010 of 93,000 hip prosthetics with higher-than-expected failure rates.

In 2007, the FDA required J&J to submit a so-called 510(k) application to review the Prolift, Liscinsky said. The FDA learned of the Prolift after J&J cited it in July 2007 as a predicate for a follow-on device, the Prolift+M, she said.

J&J introduced the original Prolift in March 2005 after “applying the relevant FDA guidance and based on the safety and effectiveness” of Gynemesh, Matthew Johnson, a spokesman for the New Brunswick, New Jersey-based company, said in an e-mail.

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Align Technology, Inc. (Nasdaq:ALGN) announced on March 14, 2012, Lead Plaintiff Plumbers and Pipefitters National Pension Fund dismissed with prejudice its shareholder lawsuit against the Company and President and CEO, Thomas M. Prescott, filed in August 2009 in the United States District Court for the Northern District of California, Case No. 3:09-cv-03671-MMC.

The case was dismissed pursuant to a stipulation between the parties that prevents them from seeking or asserting any claims against one another for fees, expenses, costs, or sanctions. The stipulated dismissal with prejudice terminates the matter and follows the Court's previous dismissal of plaintiff's second amended complaint for failure to state a claim on February 3, 2012.

Also Wednesday:

Abiomed Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced the appointment of Susan Vissers Lisa, CFA, as Senior Director of Investor Relations and Corporate Development.

Astex Pharmaceuticals, Inc. (NASDAQ:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced the Agenda for its Annual Analyst and Investor Day webcast, to take place from 10 am to 12 pm ET on Tuesday, March 27th in New York.

Baxter International Inc. (NYSE: BAX) and The Baxter International Foundation, the philanthropic arm of Baxter, today announced combined charitable giving of more than $80 million in 2011.

Bioline, The PCR Company, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO), today announced that it has received clearance from the Therapeutic Goods Administration (TGA) for its illumigene Group B Streptococcus (GBS) test, the newest molecular product on the illumigene platform.

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced additional analyses from the ARISTOTLE and AVERROES clinical trials will be presented at the American College of Cardiology’s 61st Annual Scientific Session, March 24-27, 2012, in Chicago.

Cerus Corporation (NASDAQ: CERS) announced today that it has submitted an IDE supplement to the U.S. Food and Drug Administration (FDA) for the company’s proposed Phase III trial of the INTERCEPT Blood System for red cells in patients receiving chronic red cell transfusion support for sickle cell disease (SCD) or thalassemia.

EasyMed Services, Inc. (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6), a leading provider of mobile technology solutions for the healthcare industry, reported today after the successful completion of its Easy SmartCare deployment in IIM clinic (one of the largest radiology clinics in Geneva) outstanding results on absenteeism and clinic management.

GE Healthcare, the healthcare business of GE (NYSE: GE) announced today the official opening of its expanded Fast Trak Training Center in Shanghai, China.

Today, the third and final day of BIO-Europe Spring® 2012, Index Ventures announced the launch of a EUR 150 million life science investment fund with heavy backing from GlaxoSmithKline (GSK) and Johnson & Johnson (J&J).

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics, will present a corporate overview and update at the Maxim Group Growth Conference being held on Monday, March 26, 2012 at The Grand Hyatt Hotel, Grand Central Station, New York.

Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and commercialization of molecular diagnostic tests for cancer, will announce its fourth quarter and full-year 2011 financial results and an operational update in a press release to be issued before the market opens on Tuesday, March 27, 2012.

Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that Nancy A. Simonian, M.D. has been appointed to the company’s Board of Directors.

Stellar Pharmaceuticals Inc. ("Stellar") (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF), a Canadian public company) announced on Monday, March 19, 2012 the Company would host a conference call at 4:00 p.m. Eastern Time to discuss the details of the approval of CAMBIA®, (diclofenac potassium for oral solution) for the treatment of migraine attacks with or without aura in adults, by Health Canada as noted in the press release dated Friday, March 16, 2012.

Techs Loanstar, Inc. (OTCQB: TCLN) (PINKSHEETS: TCLN), d/b/a Quture, Inc., the future in global health and healthcare quality, patient safety and value, announced today that the company's senior management team is in attendance at the 2012 InterSystems Global Summit in Orlando.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it is transferring the listing of its American Depositary Shares (“ADSs”), each representing one ordinary share of Teva common stock, to the New York Stock Exchange (NYSE) from the NASDAQ Global Select Market (NASDAQ).

Eli Lilly to Focus on Cancer, Diabetes in China; Pfizer’s Rheumatoid Arthritis Pill: Not A Slam Dunk

Wed, 21 Mar 2012 12:33:00 -0400

Below is a look at some of the headlines for companies that made news in the healthcare sector on March 20, 2012.

Eli Lilly & Co. (NYSE:LLY) will introduce more than a dozen products in China, including drugs for diabetes and cancer, in the next five years to help maintain sales growth, Chief Executive Officer John Lechleiter said.

“Our goal is to be the fastest growing pharmaceutical company in China,” Lechleiter told reporters at a briefing in Beijing today. “We are increasing our investments in every aspect of our business,” he said.

Lilly’s Chinese sales grew by 25 percent last year, faster than the industry average, after the Indianapolis-based drugmaker doubled its sales force in the Asian country over a three-year period, according to Lechleiter. The 58-year-old executive plans to raise Lilly’s share of revenue from China to more than 2 percent by focusing on “unmet needs.”

As diabetes rates soar in China, Lilly is competing with drugmakers including Merck & Co. (NYSE:MRK) and Sanofi (NYSE:SNY) to try and unseat Bayer AG and Novo Nordisk A/S (NYSE:NVO) as the biggest providers of diabetes medicines. At stake is a market that may triple to $2.1 billion in annual sales by 2019 from $700 million in 2009, according to Yifi Liu, an analyst for Datamonitor in Shanghai.

Diabetes treatments were probably the main driver of Lilly’s 31 percent growth in third-quarter sales in China, Lechleiter said in November.

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For the past couple of years, Wall Street has bet a forthcoming Pfizer (NYSE:PFE) treatment for rheumatoid arthritis called tofacitinib will become a blockbuster and, crucially, help the drugmaker overcome the arrival of generic competition to several of its biggest selling meds. Why are investors so keen about tofacitinib? The drug would become the first oral biologic for treating this particular affliction.

To be more specific, recent data indicated the Pfizer pill would offer similar efficacy to a group of injectable meds - notably Humira, which is sold by Abbott Laboratories (NYSE:ABT) - that collectively generate some $13 billion annually for treating rheumatoid arthritis alone. A pill, however, is more convenient, suggesting Pfizer can charge a premium and eventually generate some $1.5 billion in annual sales, according to some estimates.

Such talk conjures up images of an endless stream of ringing registers. But what do payers and rheumatologists think? When offered tofacitinib data, they are having what might be called a show-me moment. To be specific, a new survey finds that 55 percent of these doctors say the Pfizer pill would not replace a med they are currently prescribing. And 96 percent of the payers say tofacitinib would not replace a drug that is currently offered in their plans.

Also Tuesday:

Abiomed Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced its schedule of events at the American College of Cardiology (ACC) 2012 Scientific Sessions in Chicago, IL.

ActiveCare, Inc. (OTCBB: ACAR), the service leader in telehealth and personal emergency response, today announced that ActiveCare has obtained a contract with approximately 1,300 members through its wholly owned subsidiary 4G Biometrics.

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced it will continue its collaboration with Dr. Samir N. Khleif, the former Chief of the Vaccines Section at the National Cancer Institute (NCI), at his new position of Director of the Georgia Health Sciences University Cancer Center at Augusta, Georgia.

AmbiCom Holdings, Inc. (PINKSHEETS: ABHI) (OTCQB: ABHI), a leading designer and developer of wireless products for the medical industry, today announced that its wholly-owned subsidiary E-Care USA has signed a distribution agreement with Soladey International Ltd. to distribute Soladey Solar Toothbrushes and refills in North America.

ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation and other cardiovascular diseases, announced today that a Gencaro (bucindolol hydrochloride) abstract has been selected for moderated poster presentation at the American College of Cardiology 61st Annual Scientific Sessions & Expo, being held March 24-27, 2012 in Chicago, Illinois.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that data from studies of the Pill-Plus “triple component” oral contraceptive were presented on March 10, 2012 by Pantarhei Bioscience at the World Congress of Gynecological Endocrinology in Florence, Italy.

Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Company to market the Covidien Nellcor™ Respiration Rate Version 1.0 software and the Adult Respiratory Sensor.

In honor of the first ever HAE Day upcoming on May 16, 2012, Dyax Corp. (NASDAQ: DYAX), the manufacturer of KALBITOR® (ecallantide) for the treatment of acute attacks of HAE in patients 16 years of age and older, announced a donation of $17,700 to the United States Hereditary Angioedema Association (HAEA), the largest Hereditary Angioedema (HAE) patient group in the world.

Enzo Biochem Inc. (NYSE: ENZ) announced today an expanded business arrangement between its wholly owned subsidiary, Enzo Life Sciences, and Tokyo-based Cosmo Bio Co., Ltd. (JASDAQ: 3386).

Lightlake Therapeutics Inc. (OTCBB: LLTP), an early stage biopharmaceutical company developing modern addiction treatments based on its expertise using opioid antagonists, announced today that the last patient involved in the Phase II Trial of the Company's proprietary treatment for Binge Eating Disorder is scheduled to be seen on March 27th, with the statistical analysis of the results of the Trial taking place thereafter.

Medical tourism facilitator Global Health Voyager (OTCBB: GLHV) has announced a new data partnership to provide medical tourists with HIPPA-compliant records storage.

International Stem Cell Corporation (OTCBB: ISCO) (www.internationalstemcell.com) today announced year-end financial results for the year ended December 31, 2011.

Monar International Inc. (OTCBB:MNAI), today announced that it has initiated a new business strategy which it believes will significantly increase the scale and profitability of its China business activities and will enhance shareholder value.

NovaDel Pharma Inc. (OTC BB: NVDL) today reported unaudited financial results for the fourth quarter and year ended December 31, 2011.

Obagi Medical Products, Inc. (Nasdaq:OMPI), a leader in topical aesthetic and therapeutic skin health systems, released the results of three new studies this weekend at the American Academy of Dermatology meeting in San Diego, CA.

Oramed Pharmaceuticals Inc. (OTCBB: ORMP) (www.oramed.com), a developer of oral drug delivery systems, announced today that its work entitled "Decreased CRP levels in response to a six-week, once-daily oral insulin regimen" will be presented at the XVI International Symposium on Atherosclerosis (ISA2012) on March 25-29, 2012, to be held in Sydney, Australia.

Pacira Pharmaceuticals, Inc (Nasdaq: PCRX) today announced that financial results for the company's fourth quarter and year ended Dec. 31, 2011, will be released before the market opens on Tuesday, March 27, 2012.

The PCR Company, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO), was founded in London, UK in 1992 by Marco Calzavara, President of Meridian Bioscience Europe.

Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced that it will release its fourth quarter and full year 2011 financial results before the U.S. stock market opens on Wednesday, March 28, 2012 and has scheduled a conference call at 9:00 am EST that day to discuss the financial results.

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) reported on data presented at the Third International Symposium on Thymosins in Health and Disease in Washington, D.C.

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it filed its definitive proxy statement and sent a letter to shareholders of Illumina, Inc. (NASDAQ: ILMN) urging them to tender their shares into Roche’s offer and vote for Roche’s independent director nominees and other proposals at the 2012 Illumina annual meeting to be held on 18 April 2012.

Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today that its wholly owned subsidiary Light Instruments Ltd. ("Light") has initiated a voluntary field action regarding LiteTouch dental laser systems installed at customers' sites in Europe.

Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today that it made an equity investment in Juvenis, an Israel-based company focused on commercializing advanced biopolymer compounds for use in aesthetic tissue augmentation. Juvenis' first product under development is Tenergel™, a unique dermal filler initially intended for use in high-volume aesthetic applications and body contouring procedures.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that it has appointed David M. Sabatini, MD, PhD, to its Scientific Advisory Board.

Transgenomic, Inc. (OTCBB: TBIO) today announced that it has begun a collaboration with The University of Texas MD Anderson Cancer Center to evaluate the use of the Company’s very high sensitivity ICE COLD-PCR mutation detection technology in analysis of DNA isolated from circulating tumor cells (CTCs) in blood samples from patients with advanced cancer.

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (PINKSHEETS:VRSEF) (FRANKFURT:V3T), a leader in cancer detection technology, announced today that the results of the statistical analysis completed by researchers at Vancouver General Hospital ("VGH"), the BC Cancer Agency ("BCCA"), and the University of British Columbia ("UBC") on data from a clinical study of the Verisante Aura™, have been accepted for publication by Cancer Research, a peer reviewed journal of the American Association of Cancer Research ("AACR").

Walgreens (NYSE: WAG) (NASDAQ: WAG) will release its fiscal 2012 second quarter earnings results at 7:30 a.m. Eastern time Tuesday, March 27, followed by a conference call with Walgreens management beginning at 8:30 a.m. Eastern time.

This Week In Diagnostics

Wed, 21 Mar 2012 12:21:00 -0400

Skin cancer detection clinical study results to be published in Cancer Research

Vancouver-based Verisante Technology (TSX VENTURE: VRS) said that the results of the statistical analysis on data from a clinical study of the Verisante Aura™, have been accepted for publication by Cancer Research, a peer reviewed journal of the American Association of Cancer Research. The paper, titled Real-time Raman spectroscopy for in vivo skin cancer diagnosis, was co-authored by Drs. Harvey Lui, Jianhao Zhao, David McLean and Haishan Zeng, researchers at the Vancouver General Hospital, the BC Cancer Agency and the University of British Columbia.

The Verisante Aura™ is an imaging and spectroscopy system that scans for 21 different cancer biomarkers in less than one second; providing immediate, accurate results. Aura™ is indicated for use for the evaluation of skin lesions that may be clinically suspicious for melanoma, squamous cell carcinoma, basal cell carcinoma, and/or actinic keratosis when a medical professional chooses to obtain additional information to rule out one of the above conditions before making a final decision to biopsy.

PositiveID receives patent

PositiveID Corporation (OTCBB:PSID) reports that it was awarded U.S. Patent No. 8,133,451 for its Dragonfly™ Rapid MDx Cartridge-based diagnostic system, which provides the ability to deliver molecular diagnostic results from a sample in less than 30 minutes.

Quest Diagnostics launches renal test

Quest Diagnostics (NYSE: DGX) says it has launched the industry’s first molecular blood test for identifying renal (kidney) organ-transplant rejection. The Renal Transplant Monitoring laboratory-developed test is designed to help physicians detect kidney failure weeks before conventional tests or clinical symptoms signify damage. The new test is based on the RNA genetic markers forkhead box P3 (FoxP3), granzyme B (GZMB), and perforin (PRF1) licensed exclusively from Boston-based Beth Israel Deaconess Medical Center and New York City-based Weill Cornell Medical College, the medical school of Cornell University, among other markers.

MabCure to evaluate MAbs for use as diagnostics

MabCure Inc., (OTCBB:MBCI) has entered into an agreement with the City University of New York Center for Advanced Technology (CUNY CAT) to evaluate its monoclonal antibodies against ovarian cancer cells as diagnostic reagents. These antibodies were developed earlier by MBCI and have shown significant promise in detecting ovarian cancer in blood samples and distinguishing between cancer and benign tumors of the ovaries. Following validation, the company plans to evaluate the performance of its antibodies in diagnosing ovarian cancer in blood samples obtained from its completed Thai study as well as samples obtained from patients previously admitted to the Department of Gynecologic Oncology, Catholic University Hospital, Leuven in Belgium.

-Peter Winter

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