Proactiveinvestors USA & Canada Bristol-Myers Squibb Co Proactiveinvestors USA & Canada Bristol-Myers Squibb Co RSS feed en Thu, 18 Jul 2019 22:41:22 -0400 Genera CMS (Proactiveinvestors) (Proactiveinvestors) <![CDATA[News - Baird analysts stay Neutral on biotech sector as 2019 gets underway ]]> Baird analysts forecast that there will be as many headwinds for the biotech sector as tailwinds in 2019 and say they are sticking to a Neutral outlook on the sector, according to a new research note.

While the speed of the sell-off in biotech shares at the end of 2018 means they could see “a bit of a bounce” and Bristol-Myers Squibb’s (NYSE:BMY) move to buy Celgene (NASDAQ:CELG) for $74 billion has generated a flurry of attention, Baird’s Brian Skorney and Michael Ulz “just don’t see much reason” for the sector to re-rate.

READ: Biotech CEOs see Bristol-Myers' $74B acquisition of Celgene as a win

“The end of 2018 did not go well, and biotech investors remain a bit shell-shocked,” Skorney and Ulz wrote in a note to investors. “With more FDA approvals, but lower peak sales for drugs on the horizon, it’s hard for us to get more excited than we were at the beginning of last year.”

On the mergers and acquisitions front, it remains unclear whether the marriage of Bristol-Myers Squibb and Celgene will “change the tune” in the sector. And Skorney and Ulz predict that consolidation is more likely to come in the large-cap space and are not betting on a surge in smaller deals.

Sector offers diamonds in the rough for stock pickers

But when it comes to picking biotech stocks, Skorney and Ulz argue that there are some diamonds in the rough.

Vertex Pharmaceuticals Inc (NASDAQ:VRTX) remains Skorney’s top large-cap pick as he thinks growth investors will look to increase stakes in one of the few S&P 500 names that is “really growing.”

Intercept Pharmaceuticals Inc (NASDAQ:ICPT) is also on Skorney’s list of bets as its REGENERATE Phase 3 data could become a catalyst to support the first-approved drug to treat nonalcoholic steatohepatitis (NASH), a type of non-alcoholic fatty liver disease.

Aimmune Therapeutics Inc (NASDAQ:AIMT) is Skorney’s final pick. Its lead investigational drug, AR101 for peanut allergies, is in the final stages of clinical testing to support regulatory approval. “AR101 approval should catalyze enthusiasm for a second half of 2019 launch of the first treatment for peanut allergy,” concludes Skorney.

Ulz’s top stock pick in the sector, meanwhile, is BioMarin Pharmaceutical Inc (NASDAQ:BMRN) thanks to its strong, diversified base business and the promise of its drug valrox, which treats hemophilia A as well as vosoritide, which takes aim at achondroplasia, the most common form of dwarfism.

--Contact Ellen Kelleher at

Fri, 04 Jan 2019 08:50:00 -0500
<![CDATA[News - Bristol-Myers Squibb shares fall after FDA delays approval for lung cancer therapy ]]> Bristol-Myers Squibb Company (NYSE:BMY) stock slumped Monday after the US Food and Drug Administration delayed for three months, until May 2019, a decision on its combination drug treatment for lung cancer.

In a statement, Bristol-Myers said new data submitted by the company was viewed by the FDA as a major amendment to its drug application and extended its PDUFA date to May 20, 2019. The new information that Bristol-Myers submitted to the FDA is about the overall survival for patients whose tumors have a relatively low level of mutations.

The trial in the US is called CheckMate-227. It is an ongoing Phase 3 study of Opdivo plus another dose of a Bristo-Myers drug, Yervoy, against chemotherapy in small cell lung cancer.

As part of the ongoing EU review process, the Committee for Medicinal Products for Human Use (CHMP) requested additional information, including an overall survival (OS) analysis of Opdivo plus Yervoy in patients.

READ: Bristol-Myers Squibb's 2Q earnings beat Street on healthy sales of its blockbuster cancer drug Opdivo

The impact on Bristol shares was negative. 

Bristol-Myers stock retreated 5.5% to $51.27, trading between $50.51 and $51.90.

Opdivo harnesses the body’s own immune system to fight cancer, having become an important treatment option across multiple cancers. 

Bristol-Myers Squibb is a global biopharmaceutical company which tries to develop and deliver medicines that help patients over serious diseases.

The company is based in Princeton, New Jersey.

Reporting by Rene Pastor, contactable on

Mon, 22 Oct 2018 11:36:00 -0400
<![CDATA[News - Bristol-Myers Squibb's 2Q earnings beat Street on healthy sales of its blockbuster cancer drug Opdivo ]]> Bristol-Myers Squibb Co (NYSE:BMY) reported second-quarter earnings Thursday that topped Wall Street estimates on strong sales of its blockbuster cancer drug Opdivo and blood thinner Eliquis.

For the quarter ended June 2018, the New York-based pharmaceutical giant posted earnings of US$1.01 per share on revenue of US$5.7bn. This handily beat consensus estimates of US$0.87 per share on revenue of US$5.4bn. Revenue grew 10.9% on a year-over-year basis.

“We had a very good second quarter where we delivered strong performance for Eliquis and Opdivo, and achieved important regulatory and data milestones supporting our Immuno-Oncology portfolio,” said Bristol-Myers Squibb CEO Giovanni Caforio.

READ: Cancer doctors offer key takeaways from American Society of Clinical Oncology conference

“We are focused on robust commercial execution and the evolution of our diversified pipeline to deliver transformational medicines,” he added.

Shares of the drugmaker seesawed, declining 1.4% to Us$58.18 in the morning session after rising more than 3% when the market opened.

Analysts hailed the performance of Opdivo alone and in combination with its other immuno-oncology drug Yervoy as positive, but there’s fierce competition brewing from rival immunotherapies, especially Merck & Co’s (NYSE:MRK) Keytruda, which recently won a priority review as a treatment for advanced lung cancer.

"The performance is encouraging, but immuno-oncology competition is intensifying," BMO Capital Markets analyst Alex Arfaei wrote in a research note seen by Reuters. "Therefore, R&D and commercial execution in immuno-oncology remains paramount."

Bristol-Myers stock took a beating earlier this year when Merck presented promising survival data for Keytruda in non-small cell lung cancer.

Still, Bristol-Myers raised its full-year earnings forecast to between US$3.55 and US$3.65 per share. The company's previous guidance was earnings of US$3.35 to US$3.45 per share. The current consensus earnings estimate is a more conservative US$3.43 per share for the year ending December 31, 2018.

Contact Uttara Choudhury at

Follow her on Twitter: @UttaraProactive 

Thu, 26 Jul 2018 11:41:00 -0400
<![CDATA[News - Cancer doctors offer key takeaways from American Society of Clinical Oncology conference ]]> An important takeaway to come out of the American Society of Clinical Oncology conference early this month is that Merck’s lung cancer-fighting drug Keytruda is quite similar in its efficacy and safety to Bristol-Myers Squibb Co’s (NYSE:BY) Opdivo.

This insight is the view of two attendees at the ASCO conference,  Dr. Jack Goldberg, chief of hematology and medical oncology at Penn Presbyterian Medical Center and Dr. Igor Genkin who practices in the Bronx with an emphasis on biomarker development.

Both offered opinions on the conference to Oppenheimer analysts.

“These doctors view Keytruda and Opdivo as very similar in terms of efficacy and safety with differences arising from their respective study designs in lung cancer,” wrote Oppenheimer analysts.

The stage three data for AstraZeneca PLC’s (NYSE:AZN) rival drug Imfimzi is also seen by both doctors as compelling and the data on the drug provided at ASCO will likely accelerate utilization, the doctors predict.

Another drug therapy both Goldberg and Genkin are positive on is the combination of Opdivo with Yervoy in lung cancer patients.

Both believe that precision oncology is likely to become “very impactful to their practices” as new emphasis is placed on targeting mutations rather than the cells of origin. They are also bullish on the use of biomarkers in their practices and look forward to future clinical studies.

In other news today, Merck (NYSE:MRK) confirmed that the US Food and Drug Administration has also approved Keytruda, a popular weapon against lung cancer, for the treatment of patients with recurrent or metastatic cervical cancer.

Tue, 12 Jun 2018 16:29:00 -0400
<![CDATA[News - Bristol Myers Squibb showcases positive results of new Phase 3 study evaluating cancer drug Opdivo ]]> The pharmaceutical giant Bristol Myers Squibb (NYSE:BMY) today revealed positive results from a new study evaluating its lead cancer drug Opdivo.

The pharma company’s Phase 3 CheckMate-227 trial evaluated the effectiveness of Opdivo (nivolumab) plus a low dose of Yervoy (ipilimumab) as well as chemotherapy against chemotherapy alone in patients with advanced non-small cell lung cancer with PD-L1 expression of less than 1% across squamous and non-squamous tumors.

The results suggest that Opdivo in combination with chemotherapy extended progression-free survival versus chemotherapy alone in this subset of patients.

“Results show Opdivo plus chemotherapy improved progression-free survival versus chemotherapy in first-line lung cancer patients whose tumors do not express PD-L1,” said Hossein Borghaei, the study’s investigator and chief of thoracic medical oncology at Fox Chase Cancer center in Philadelphia.

The results from Part 1b of CheckMate 227 will be presented today at the American Society of Clinical Oncology's annual meeting in Chicago.

READ: Bristol-Myers beats 1Q estimates, guides higher for full-year 2018 on drug approvals

CheckMate 227 is an open-label Phase 3 trial aimed at evaluating Opdivo versus platinum-doublet chemotherapy in patients with advanced non small cell lung cancer.

In pre-market trade, Bristol Myers Squibb shares were down about 1% at US$52.60.

Mon, 04 Jun 2018 08:04:00 -0400
<![CDATA[News - Bristol-Myers beats 1Q estimates, guides higher for full-year 2018 on drug approvals ]]> Bristol-Myers Squibb (NYSE:BMY), the pharmaceutical giant, beat Wall Street’s estimates on first-quarter profits, matched on revenues and guided higher on its full-year 2018 earnings forecast.

Bristol-Myers Squibb reported earnings of $0.94 per share on revenue of US$5.2bn. The consensus estimate from analysts came to US$0.85 per share on revenue of US$5.2bn.

Bristol also fared well in the quarter on the drug development front and its results from a clinical trial of Opdivo, its immunotherapy drug as well as another of its cancer-fighting medicines Yervoy cheered investors. When taken in combination, the pair of drugs cut the risk of cancer progression or death in clinical trials by 42% when compared to chemotherapy.

The combination of Opdivo plus Yervoy has been approved in the U.S. for patients with intermediate and poor risk advanced renal cell carcinoma.

READ: Bristol-Myers falls after Citi analyst says Pfizer not interested in buying the drugmaker

“We … obtained FDA approval for Opdivo plus Yervoy in renal cell carcinoma, a disease with high unmet need which represents an important opportunity for the company,” said Giovanni Caforio, chairman and chief executive officer of Bristol-Myers Squibb. “I am confident that strong commercial execution, upcoming Phase 3 readouts across our oncology pipeline and continued strategic use of business development position us well for future growth.”

Bristol’s revenue for the quarter jumped 5% to US$5.19bn, up from US$4.93bn in the same period last year.

Bristol also managed to increase its earnings guidance for 2018 to US$3.35 to US$3.45 per share, up from its previous forecast of US$3.15 to US$3.30 per share and higher than Wall Street’s estimate of US$3.22 per share. 

In pre-market trade, Bristol-Myers Squibb shares edged up slightly to US$52.20.

Thu, 26 Apr 2018 08:18:00 -0400
<![CDATA[News - Bristol-Myers falls after Citi analyst says Pfizer not interested in buying the drugmaker ]]> Bristol-Myers Squibb Co (NYSE:BMY) shares were down Thursday while Pfizer Inc. (NYSE:PFE) rose after an analyst for Citi Investment Research said a deal between the two drugmakers isn't likely to happen.

Bristol-Myers lost 2% to US$58.96, while Pfizer rose 1.7% to US$36.38 in midday trade.

Citi analyst Andrew Baum said he met with Pfizer CEO Ian Read and he had "no interest" in Bristol-Myers or other major deals right now.

"In our meeting yesterday with Pfizer’s CEO, COO and CSO, Pfizer made clear that they had no interest in BMY in the absence of transformational data or de-rating of the shares,” Baum was quoted as saying in a Citi research report shared with

In February, Baum had laid out a scenario where Pfizer may look to buy its rival despite its large market cap.

The Citi analyst cut his price target to US$70 from US$78 after he removed a US$8 a share M&A risk premium from his target price.

"We view our newly lowered target price as conservative given the absence of contribution from CHECKMATE-9LA in 1st line non-small cell lung cancer,” Baum wrote in the report.

Investors will get a look at results next week from Bristol-Myers’s Phase 3 study of Opdivo and Yervoy in patients newly diagnosed with advanced lung cancer with high tumor mutational burden.

The New York-based drugmaker will hold an investor event to discuss the lung-cancer data on Monday at 5 p.m. CT.

Teaming up with Harvard researchers

Separately, Bristol-Myers announced on Thursday that it was working on research with the Harvard Fibrosis Network of the Harvard Stem Cell Institute to develop potential new therapies for fibrotic diseases, including fibrosis of the liver and heart.

“Bristol-Myers Squibb strives to develop transformational therapies that arrest or reverse the progression of fibrosis and restore organ function,” said Carl Decicco, head of discovery at Bristol-Myers Squibb. “We believe this collaboration will advance fibrosis research…and the development of new therapies for patients with these debilitating conditions.”

Thu, 12 Apr 2018 12:52:00 -0400
<![CDATA[News - Bristol-Myers Squibb’s new dosing for cancer drug Opdivo gets FDA green light ]]> Bristol-Myers Squibb Co (NYSE:BMY) said the US Food and Drug Administration (FDA) has given the green light for a new dosing schedule for its drug Opdivo, for a number of cancers that it is already approved for.

The approval is for a supplemental Biologics Licence Application (sBLA) which updates the Opdivo (nivolumab) dosing schedule to include 480 mg infused every four weeks.

READ: Bristol-Myers shares on the uptick after positive lung cancer trial results and market beating fourth quarter results

Opdivo is already approved for every two weeks at 240 mg and for a shorter 30-minute infusion across all approved indications.

The company said in a statement that the dosing schedule updates for an additional approved indication may be submitted to the FDA in the future.

Jeffrey S Weber, the deputy director of the Perlmutter Cancer Center at NYU Langone Health: “… some patients may need the support of two-week visits with their health care team, while for others, a four-week interval may be more appropriate and better suited to their treatment needs. With this approval, we now have additional ways to help tailor patient care.”

Tue, 06 Mar 2018 07:49:00 -0500
<![CDATA[News - Bristol-Myers shares on the uptick after positive lung cancer trial results and market beating fourth quarter results ]]> Bristol-Myers Squibb Co (NYSE:BMY) shares were on the rise in pre-market trade after the company reported positive results for its lung cancer trial as well as market-beating fourth quarter numbers.

In a statement, the company said the Opdivo and Yervoy cancer drug combination showed improved progression-free survival in patients with advanced lung cancer compared to chemotherapy in a Phase III trial.

READ: Bristol-Myers Squibb drops on surprise third quarter profits miss

BMS said the trial will continue because an interim analysis looking at overall survival looked promising.

On the results front, BMS reported a loss of US$2.33bn, or a loss of US$1.42 per share, from a profit of US$894mln or 53 US cents a year ago.

Like other corporates, the results included the impact of the new US tax law, which saw a onetime charge of US$2.9bn in the fourth quarter.

Revenue rose to US$5.45bn from US$5.24bn recorded a year earlier, and ahead of market expectations for USUS5.35bn.

Opdivo, Eliquis, Sprycel and its Sustiva franchise saw sales beating market consensus. However, Orencia, Yervoy, Empliciti, Baraclude, Reyataz and its Hepatitis C franchise saw sales coming in below consensus.

“I am proud of our results in 2017, with sales growth driven by strong commercial performance of our prioritized brands and important scientific advances we are making across our pipeline,” said Giovanni Caforio, chairman and chief executive officer.

"As we begin 2018, I am confident that we are well positioned for long-term growth through our strong commercial and R&D capabilities in bringing transformational medicines to patients with serious diseases.”

READ: Bristol Myers Squibb kidney cancer treatment meets endpoint of late-stage trial

BMS is now guiding 2018 adjusted EPS to come in between US$3.15 to US$3.30, in the middle of Wall Street’s consensus of US$3.23. It also guided on global revenue growth at low- to mid- single digits.

In pre-market trade, BMY shares were up 3.09% at US$65.44.

Mon, 05 Feb 2018 08:04:00 -0500
<![CDATA[News - Bristol-Myers Squibb drops on surprise third quarter profits miss ]]> Shares in Bristol Myers Squibb Co (NYSE:BMY) slipped in pre-market trade on Thursday after the pharmaceutical giant’s third quarter profits missed expectations, despite revenues coming ahead of Wall Street forecasts.

The New York-based group, which has a market cap in excess of US$100bn, saw revenues rise to US$5.25bn (Q3 2016: US$4.92bn) in the three months ended September 30, ahead of the US$5.19bn expected by analysts.

Bristol couldn’t translate the top-line beat into higher profits, which instead slumped to US$845mln or 51 cents per share from US$1.20bn or 72 cents a share in the year-earlier period.

Adjusted earnings per share for the quarter was 75 cents, below the consensus forecast of 77 cents.

Strong sales of BMY’s Opdivo and Empliciti cancer drugs couldn’t offset poor performance from a host of others, including skin cancer treatment Yervoy, Eliquis deep vein thrombosis pills and rheumatoid arthritis drug Orencia.

As for its full-year outlook, Bristol decreased its EPS guidance to between US$2.36 and US$2.46 (from US$2.66 to US$2.76), although it did increase its adjusted EPS guidance to US$2.95 to US$3.05 (from US$2.90 to US$3.00).

Dr Giovanni Caforio, chairman and chief executive officer, said: “Looking forward, our focus is on continuing to deliver strong commercial performance, advance our pipeline and ensure our resources are applied to priority areas of our portfolio for sustainable, long-term growth.”

Shares were down 1.6% to US$63 in pre-market trade.

Thu, 26 Oct 2017 08:37:00 -0400
<![CDATA[News - Bristol Myers Squibb kidney cancer treatment meets endpoint of late-stage trial ]]> Bristol-Myers Squibb Co. (NYSE:BMY) has announced that a late-stage trial of its Opdivo and Yervoy drugs for treating a type of kidney cancer has met one of its main end-points. 

The trial showed patients with previously untreated advanced or metastatic renal cell carcinoma had a better overall survival with the combination of the two drugs compared to chemotherapy in intermediate and poor risk patients.

The combination treatment also showed to have improved overall survival compared with chemotherapy in all randomised patients.

In reaction, shares rose 1.10% to US$59.87 each in US pre-market trading.

Last month, the company the same late-stage trial had revealed that while the treatment had met one of the main end-points of objective response rate, it had failed to improve progression-free survival in patients.

It continued the trial to evaluate overall survival rates, an end-point which it has now met.

An independent Data Monitoring Committee has recommended the trial be stopped early, based on a scheduled interim analysis, the company said.

Renal cell carcinoma is the most common types of kidney cancer in adults. It accounts for more than 100,000 deaths globally each year.

Following Opdivo’s failure to prolong survival in previously untreated patients with non-small cell lung cancer, Bristol Myers has fallen behind rival Merck & Co in the key field of immune-oncology.

Thu, 07 Sep 2017 14:31:00 -0400
<![CDATA[News - Bristol Myers Squibb buoyed by surge in sales of key drugs ]]> Thu, 27 Apr 2017 14:07:00 -0400 <![CDATA[News - Bristol-Myers enters into two license deals with Biogen and Roche worth up to US$1.1bn ]]> Shares in Bristol-Myers Squibb Co (NYSE:BMY) edged higher in pre-market trading on Thursday after the pharma giant told investors it had entered into separate licence deals with Biogen Inc (NYSE:BIIB) and Roche.

In total, Bristol-Myers will receive a combined upfront fee of US$470mln plus up to a further US$615mln in potential milestone payments.

Bristol will license its experimental neurodegenerative disorder drug, BMS-986168, to Biogen for use in progressive supranuclear palsy, which can cause serious problems with walking, balance and eye movements.

Biogen will pay US$300mln upfront plus up to US$410mln in milestone payments.

In a separate deal, NYSE-listed Bristol will also licence its anti-myostatin adnectin for use in the treatment of Duchenne muscular dystrophy to Roche for US$170mln upfront plus up to US$205mln in milestone payments.

The agreements are still subject to regulatory approval but, assuming they get the green light, they’re expected to close later this quarter.

Shares in Bristol-Myers were up more than 1% to US$53.57 in the pre-market.

Thu, 13 Apr 2017 08:48:00 -0400
<![CDATA[News - Bristol-Myers shares hit by new lung cancer disappointment ]]> Bristol-Myers Sqibb Co’s (NYSE:BMY) faltering lung cancer programme suffered another setback after it dropped plans to file for accelerated approval of an immunotherapy combination.

In a statement, Bristol Myers said it had made the decision about Opdivo/Yervoy after assessing the data available.

The news was set to knock US$6bn off the pharma giant’s market value when trading got underway, while giving a major boost to rival Merck that has a competing drug.

Merck’s treatment for first line lung cancer, Keytruda, received regulatory approval last December.

Checkpoint inhibitor Opdivo is big earner for Bristol Myers, but a failure of its trial as a single therapy for non-small cell lung cancer wiped US$24bn from the company’s value in August due to the size and importance of this market.

After that result, analysts said the best hope in this indication was a combination therapy where four trials are currently underway.

A filing for approval will not now likely go ahead under 2018 and that depends on results from the trials.

As well as Merck, the UK’s AstraZeneca (LON:AZN) and Swiss firm Roche also have lung cancer drugs in development.

Fri, 20 Jan 2017 13:57:00 -0500
<![CDATA[News - Bristol-Myers announces results for Opdivo ]]> Bristol-Myers Squibb Company (NYSE:BMY) on Tuesday announced updated results for Opdivo monotherapy.

The pharma said that Opdivo monotherapy (3 mg/kg every two weeks [n=98]) and in combination with Yervoy (Opdivo 1 mg/kg plus Yervoy 3 mg/kg every three weeks [n=61]) in previously treated small cell lung cancer (SCLC) patients, a cohort of the Phase 1/2 open-label CheckMate -032 trial.

The confirmed objective response rate (primary objective) was 25% (95% CI: 15, 37) in patients who received Opdivo plus Yervoy and was 11% (95% CI: 6, 19) with Opdivo alone with additional follow-up.

Response was observed regardless of platinum sensitivity or prior lines of therapy. With the combination, three patients experienced a complete response.

The estimated two-year overall survival rate (secondary objective) was 30% with Opdivo plus Yervoy and was 17% with Opdivo alone. In this updated analysis, no new safety signals were observed. Grade 3/4 treatment-related discontinuation rates were 10% in the Opdivo plus Yervoy group and 4% in the Opdivo group.

Bristol-Myers shares closed up 0.9% at $56.03 on Tuesday.

Tue, 06 Dec 2016 16:26:00 -0500
<![CDATA[News - Bristol Myers slumps as immunotherapy drug fails lung cancer trial ]]> Bristol-Myers Squib (NYSE:BMY) shed almost a fifth of its value as one of its key immunotherapy drugs failed a phase III trial as a treatment for lung cancer.

Opdivo is already approved in a number areas but did not meet its primary endpoint as a treatment for non-small cell lung cancer.

The news immediately boosted shares in Merck (NYSE:MRK), which has a rival immunotherapy treatment, Keytruda.

Bristol Myers said newly diagnosed lung cancer patients taking Opdivo showed no progression-free survival.

Giovanni Caforio, the company’s chief executive, said:  “While we are disappointed CheckMate -026 didn't meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program,”

Immunotherapy is a huge growth sector within the pharmaceutical industry and sales of checkpoint inhibitor Opdivo in other applications saored to US$840mln in the last quarter.

Lung cancer is among the deadliest forms of the disease, however,  and if successful, Opdivo may have been looking at revenues of more than US$12bn at their peak.

The trial’s failure wiped US$24bn off its market cap at one point, while boosting Merck’s value  by almost 8% to US$172bn.

Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world and currently has regulatory approval in 54 countries including the United States and Japan.

Immune checkpoint inhibitors enable the body to recognise cancerous cells and stop them going undetected by the body's natural defences.


Bristol-Myers shares closed down 16% at $63.28, after hitting an intraday low of $61.56, on Friday.

Fri, 05 Aug 2016 10:02:00 -0400
<![CDATA[News - Bristol Myers/ Janssen target lung cancer with I-O combo ]]> US giants Janssen Biotech Inc and Bristol-Myers Squibb (NYSE:BMY) are to combine two of their most promising immuno-therapy treatments to target lung cancer.

Janssen’s JNJ-64041757 is currently in Phase 1 clinical development for lung cancer, while Bristol Myers’ Opdivo is indicated for the treatment of patients with NSCLC with progression on or after platinum-based chemotherapy.

An immuno-oncology (I-O) agent, Opdivo (nivolumab) is a human antibody designed to alleviate immune suppression while Janssen’s drug is designed to induce the local recruitment and activation of innate and adaptive effector cells and expansion of mesothelin-specific T cells.

The Phase II clinical trial will evaluate the tolerability and clinical activity of the combination of these agents in non-small cell lung cancer  (NSCLC) patients.

“We are excited to collaborate with Janssen as we explore how the emerging science of antigen-presentation therapeutics, in combination with Opdivo, can potentially provide a new treatment approach for patients with lung cancer,” said Jean Viallet, a lead oncology researcher at Bristol-Myers.

Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world and currently has regulatory approval in 54 countries including the United States and Japan.

Immune checkpoint inhibitors enable the body to recognise cancerous cells and stop them going undetected by the body's natural defences.


Tue, 26 Jul 2016 08:55:00 -0400
<![CDATA[News - Bristol-Myers Squibb to get keys to Padlock ]]> Bristol-Myers Squibb Company (NYSE:BMY) is to snap up Padlock Therapeutics, it was announced on Wednesday.

The companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of Padlock, a private, Cambridge, Massachusetts-based biotechnology company dedicated to creating new medicines to treat destructive autoimmune diseases.

The acquisition will give Bristol-Myers Squibb full rights to Padlock’s Protein/Peptidyl Arginine Deiminase (PAD) inhibitor discovery program focused on the development of potentially transformational treatment approaches for patients with rheumatoid arthritis (RA).

Padlock’s PAD discovery programme may have additional utility in treating systemic lupus erythematosus (SLE) and other autoimmune diseases.

Bristol-Myers shares closed down 0.73% at $62.34.

Wed, 23 Mar 2016 16:38:00 -0400
<![CDATA[News - Global drug industry profits set to slow, says Moody's ]]> Profit increases in the global drug industry are likely to slow due to tougher pricing and the stronger US dollar, according to Moody's.

The credit rating agency has changed its outlook on the sector to stable from positive as a result of an expected "modest reduction" in earnings growth.

Moody's blamed lower pricing flexibility, the stronger US dollar and slower adoption of some new products for its revised expectations.

Moody's senior vice-president Michael Levesque said: "We now expect growth of 3%-4% versus our previous expectation of 4%-5%."

The agency said the changes to its forecasts were partly due to the controversy over high drug prices in the US, forcing manufacturers into reductions.

Pressure on prices in Europe and Japan was also a factor as drug patents expired and manufacturers faced competition from copy-cat producers.

Moody's said the stronger US dollar was likely to hit large US-based companies with overseas operations, but help non-US drug manufacturers.

It also noted that adoption rates for some products from large pharmaceutical companies had been slower than the agency expected.

But growth was still strong for cancer drugs, especially those in immuno-oncology like Bristol-Myers Squibb's (A2 stable) Opdivo and Merck's (A1 stable) Keytruda.

Levesque added: "Pharmaceutical companies will remain active in the M&A market as they try to cut costs, achieve greater scale and diversification and acquire pipeline drugs with high potential."

Thu, 03 Mar 2016 15:00:00 -0500
<![CDATA[News - Dual Therapeutics reports Bristol-Myers Squibb tie-up ]]> Oncology start-up Dual Therapeutics  has tied up with Bristol-Myers Squibb (NYSE: BMY) to advance small molecule compounds to treat cancer and other diseases.

Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialise therapeutics discovered by Dual.

"We are pleased to collaborate with Bristol-Myers Squibb, a global leader in developing oncology products,"  Baiju R. Shah, chief executive of BioMotiv, the lead investor in Dual Therapeutics.

Dual Therapeutics is based on the work of investigators at Icahn School of Medicine at Mount Sinai and Case Western Reserve University

Bristol-Myers Squibb will pay an undisclosed upfront fee and development costs and Dual Therapeutics will be eligible to receive development and regulatory milestones that could total more than US$255 million for a successful compound approved in multiple indications in addition to royalties on future sales of products discovered in the collaboration.

Fri, 08 Jan 2016 08:29:00 -0500
<![CDATA[News - Bristol-Myers to take over Crioxyl Pharma in $2.1bn deal ]]>   New York-based Bristol-Myers said in a statement on Monday that it would make an upfront payment of up to $300 mln and potentially add up to $1.775bn pending on the achievement of certain development, regulatory and sales milestones.   The transaction is expected to close before year’s end.   Bristol-Myers said the deal would be dilutive to this year’s per-share earnings by $0.12.   Bristol-Myers aims to gain access to Cardioxyl's CXL-1427, a heart failure treatment.   At least 5.1mln Americans suffer from heart failure, for which there is no cure.   Bristol-Myers said early clinical data indicate the treatment has improved how the heart contracts and relaxes without increasing heart rate or the demand for oxygen.   Shares of Bristol-Myers closed down 2% at $65.95 on Friday, paring gains this year to 12%.   Meanwhile, British drugmaker Shire said it would buy the Dyax (NASDAQ:DYAX) for about $5.9bn.     ]]> Mon, 02 Nov 2015 08:26:00 -0500 <![CDATA[News - Bristol-Myers Squibb upgrades earnings guidance ]]> Bristol-Myers Squibb’s (NYSE:BMY) share price was a picture of health after the healthcare firm’s underlying earnings per share comfortably surpassed expectations.

Although third quarter net income at US$706mln was lower than last year’s US$721mln, the earnings per share number was little changed at 42 cents (2014:43 cents).

The company’s own definition of earnings per share (EPS), which excludes one-off items and is the one also used by analysts covering the stock, saw EPS fall to 39 cents from 45 cents last year but was four cents higher than analysts had been expecting.

Furthermore, the company revised its full-year EPS guidance upwards, to a range spanning US$1.85 to US$1.90 from US$1.70 to US$1.80 previously.

Revenue rose 4%, or 11% on a constant currency basis, .

Shares were up 2.4% at US66.06 in lunchtime trading. 

Tue, 27 Oct 2015 12:37:00 -0400
<![CDATA[News - Bristol-Myers obtains rights to acquire drug developer Promedior for up to $1.25bn ]]> Bristol-Myers Squibb (NYSE:BMY), a biopharmaceutical company, said it bought rights to a mid-stage fibrosis drug and its privately held developer, Promedior Inc, for up to $1.25bn, in a move aimed at boosting its pipeline for drugs that treat tissue scarring.

The deal gives Bristol-Myers access to Promedior’s lead experimental drug, PRM-151, which is being tested to treat two types of fibrosis -- the lung condition idiopathic pulmonary fibrosis and bone marrow disorder myelofibrosis.

The drug candidate has already been granted special FDA designations allowing for speedier development and a faster review process.

Bristol-Myers Squibb will make an upfront payment of $150 million as consideration to buy rights to the drug candidate and Promedior, according to a statement released on Monday from the New York-based company.

Total payments could reach up to $1.25 billion and Bristol-Myers can exercise its right to buy Promedior upon completion of future clinical trials, Bristol-Myers said.

“PRM-151 will complement our growing early-stage fibrosis portfolio, and we are excited by its potential to address multiple fibrotic diseases,” Francis Cuss, Bristol-Myers’ chief scientific officer, was quoted in the statement as saying.

Bristol-Myers said on Monday that Promedior's mid-stage studies of its fibrosis drug are expected to begin in the next few weeks.

Shares of Bristol-Myers fell 0.5% to $60.33 at 10:41 a.m. in New York.


Mon, 31 Aug 2015 10:43:00 -0400
<![CDATA[News - Bristol-Myers rises in premarket on JPMorgan upgrade ]]> Bristol-Myers Squibb Co. (NYSE:BMY), a New York-based drug company, climbed in premarket trades after JPMorgan Chase & Co. advised investors to buy the shares.

Bristol-Myers advanced 1.2 percent to $44.10 at 4:12 a.m. in New York. The stock has rallied approximately 34 percent so far this year, giving the company a market value of $71.7 billion. 

JPMorgan boosted its recommendation for the shares to "overweight", a rating similar to buy, from "neutral".

JPMorgan analysts expect earnings of the maker of the Eliquis blood thinner and the Bydureon diabetes treatment to grow by an average 13 percent through 2020, driven by its forthcoming products. 

Analysts led by Chris Schott raised their price estimate for the stock to $52 from their earlier prediction of $50.

The current consensus among 21 investment analysts is to "hold" stock in Bristol-Myers.



Mon, 16 Sep 2013 06:44:00 -0400
<![CDATA[News - Bristol-Myers Squibb Q4 results top views, shares rise ]]>  

Global biopharmaceutical company Bristol-Myers Squibb (NYSE:BMY) saw its shares rise Thursday after it posted fourth quarter results that topped analyst views.

Shares of the company rose 2.58 per cent as at about 10:15 a.m. EDT, trading at $35.80.

Bristol-Myers also set its 2013 adjusted earnings guidance range to between $1.78 and $1.88.  

For the three months that ended December 31, 2012, net earnings were $925 million or 56 cents per share, compared to $852 million or 50 cents per share, a year ago.

Adjusted net earnings were $777 million or 47 cents per share, compared to $906 million or 53 cents per share, in the year-ago quarter.

Net sales of $4.2 billion fell 23 per cent compared to $5.5 billion in the same period a year ago, following the U.S. patent expiration of blood pressure medication Avapro/Avalide in March, and anti-stroke drug Plavix in May. 

Excluding the loss of the two medications, Bristol-Meyers said net sales grew by 13 per cent.

Analysts, according to Thomson Reuters, expected per share earnings of 43 cents on sales of $4.12 billion.

“With regulatory approvals for Eliquis and Forxiga, and good operating performance in the fourth quarter, Bristol-Myers Squibb had a strong finish to an important year of transition,” said CEO Lamberto Andreotti. 

“In 2012 we continued to effectively execute our strategy, and continued to build the post-Plavix portfolio and operating structure that provide a solid foundation for our future growth. 

“As we begin 2013, I am looking forward to our many opportunities, including the growth of the existing key brands, the execution of the new launches, and the continued delivery of a diverse and sustainable R&D pipeline.”

U.S. sales decreased 38 per cent to $2.2 billion in the quarter, while international sales rose six per cent to $2.0 billion.

Gross margin was 74.3 per cent in the quarter, compared to 74.9 per cent a year earlier, the company said.

Bristol-Myers is focused on the research and development of treatment in five key therapeutic areas: cardiovascular and metabolism, oncology, neuroscience, immunoscience and virology.


Thu, 24 Jan 2013 10:12:00 -0500
<![CDATA[News - Bristol-Myers Squibb posts Q3 loss on discontinued drug ]]>  

Global biopharmaceutical company Bristol-Myers Squibb (NYSE:BMY) Wednesday swung to a loss in the third-quarter on a charge related to the discontinued development of its hepatitis C drug, as revenues also declined. 

The company also revised its full-year adjusted per share earnings guidance range down to 95 cents to $1.05, from $1.78 to $1.88.

Shares fell 1.32 per cent as at about 10:10 a.m. EDT, trading at $32.80.

For the three months that ended September 30, net loss attributable to Bristol-Myers Squibb was $711 million, or 43 cents per share, compared to net earnings of $969 million, or 56 cents per share, a year earlier.

A non-cash impairment charge of $1.8 billion was included in the latest quarter, resulting from the discontinued development of BMS-986094 in August, which was in phase II trials for the treatment of hepatitis C.

The company reported adjusted net earnings of $685 million, or 41 cents per share, compared to $1.0 billion or 61 cents per share, for the same period in 2011. 

Total net sales fell 30 per cent to $3.7 billion, following the U.S. patent expiration of blood pressure medication Avapro/Avalide in March, and anti-stroke drug Plavix in May. 

Excluding the loss of the two medications, Bristol-Meyers said net sales grew by seven per cent compared to the third quarter of 2011.

Analysts, according to Thomson Reuters, expected per share earnings of 42 cents on sales of 3.98 billion.

“Bristol-Myers Squibb faced challenges in the third quarter, including the discontinuation of BMS-986094 for the treatment of hepatitis C,” said CEO Lamberto Andreotti.

Andreotti said the company “remains strong and well-positioned” going forward, on the achievement of regulatory milestones for stroke medication Eliquis and rheumatoid arthritis drug Orencia, the presentation of long-term survival data for skin cancer drug Yervoy, and the completion of its August acquisition of Amylin Pharmaceuticals (NASDAQ:AMLN). 

U.S. net sales decreased 43 per cent to $2.0 billion in the quarter, while international net sales fell six per cent to $1.8 billion.

Third quarter gross margin edged down to 73.6 per cent, from 73.7 per cent in the same period a year ago.

Bristol-Myers is focused on the research and development of treatment in five key therapeutic areas: cardiovascular and metabolism, oncology, neuroscience, immunoscience and virology.


Wed, 24 Oct 2012 10:11:00 -0400
<![CDATA[News - Bristol-Myers Squibb discontinues hepatitis C drug trial after patient death ]]> Global biopharmaceutical company Bristol-Myers Squibb (NYSE:BMY) late Thursday announced it would discontinue the development of its hepatitis C treatment, after a test patient died as a result of heart failure.

The company said that the decision was made in the interest of patient safety, “based on a rapid, thorough and ongoing assessment of patients in a phase II study” that it suspended on August 1. The U.S. Food and Drug Administration (FDA) subsequently placed the compound, called BMS-986094, on clinical hold.

Bristol said the initial case of heart failure, which was the basis for halting the study, “subsequently resulted in death”. 

“The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients,” said executive VP and chief scientific officer, Elliott Sigal.

“In the interest of all patients participating in hepatitis C clinical studies, and in cooperation with the FDA, we will make relevant information on BMS-986094 available to inform the development of other investigational compounds to treat hepatitis C. 

“We will also work expeditiously to share the results of our further investigations more broadly in the medical and scientific community.”

The company said it is working in close collaboration with the FDA and clinical study investigators to conduct "ongoing, comprehensive" assessments and close follow-up of all BMS-986094 study patients. 

To date, Bristol said that nine patients have been hospitalized, including the initial patient, and two patients remain hospitalized. 

“While the cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established, the company has determined that it is in the best interest of patients to halt development of BMS-986094,” it said in a release.

Bristol said it is committed to investigating this safety issue further, including studies to evaluate the potential mechanism of this toxicity. The company will continue closely monitoring and the follow-up of patients who have received BMS-986094 across all studies.

The company is focused on the research and development of treatment in five key therapeutic areas: cardiovascular and metabolism, oncology, neuroscience, immunoscience and virology.

Shares of Bristol-Myers Squibb were up 0.96 per cent as at 10:25 a.m. ET, trading at $32.45.

Fri, 24 Aug 2012 10:28:00 -0400
<![CDATA[News - Bristol-Myers Squibb profit sheds 27% as patents expire ]]> Global biopharmaceutical company Bristol-Myers Squibb (NYSE:BMY) Wednesday reported an 18 per cent decrease in net sales due to some patent expirations, and a 27 per cent drop in earnings.

For the three months that ended June 30, profit decreased to $645 million, or 38 cents per share, down from $902 million, or 52 cents per share in the year-earlier period.

Adjusted income was $808 million, or 48 cents per share, down from $971 million, or 56 cents per share, for the same period of 2011, meeting analyst expectations.

Total net sales fell 18 per cent to $4.4 billion.

The company attributed its decline in sales to the patent expiration of two of its treatments. Excluding the patents, net sales increased by 8 per cent from last year’s quarter.

"We have been preparing for the expected loss of exclusivity of Plavix and Avapro/Avalide for a number of years and I am pleased with our company's progress as we look to the future," said the company’s CEO, Lamberto Andreotti.

"With the growth of a large number of key products from across our portfolio, the promising data from our immuno-oncology franchise presented at ASCO and the innovative planned acquisition of Amylin we are building a strong foundation for success."

U.S. net sales decreased 27 per cent to $2.6 billion in the quarter, while international net sales fell 1 per cent to $1.9 billion.

Second quarter gross margin was 72.0 per cent, a slight edge down from 72.7 per cent in the prior year.

Bristol-Myers adjusted its fiscal 2012 earnings guidance to be in the range of $1.78 to $1.88 per diluted share, down from its previous guidance of $1.90 to $2.00 per diluted share.

The company is focused on the research and development of treatment in five key therapeutic areas: cardiovascular and metabolism, oncology, neuroscience, immunoscience and virology.

Shares of the drug development company were up 0.84 per cent Wednesday afternoon, at $35.02 on the New York Stock Exchange.

Wed, 25 Jul 2012 15:16:00 -0400
<![CDATA[News - Bristol-Myers rallies as it boosts stock buyback by $3 bln ]]> Global biopharmaceutical company Bristol-Myers Squibb (NYSE:BMY) saw its stock rise early Wednesday, a day after announcing that its board of directors has increased its share buyback program by $3 billion.

This is in addition to the current $3 billion repurchase program announced in May 2010, of which the company has $340 million remaining.

The program has no expiration date, and is expected to take place over the next two years.

The share repurchases can be made in open market or private transaction, and may be suspended or discontinued without prior notice, the company noted.

Bristol-Myers said it is committed to retaining the financial flexibility it needs to support its dividend, and that it will continue its focus on business development.

On Monday, shares of Pfizer (NYSE:PFE) and Bristol-Myers fell after federal regulators unexpectedly delayed for a second time a decision on whether to approve the companies' experimental anti-clotting drug Eliquis.

The FDA said it wanted more information on "data management and verification" from an international study called ARISTOTLE that examined how well Eliquis prevented strokes in patients with an irregular heartbeat.

Bristol-Myers is focused on the research and development of treatment in five key therapeutic areas: cardiovascular and metabolism, oncology, neuroscience, immunoscience and virology.

The company also declared Tuesday a regular quarterly dividend of 34 cents per share on its common stock. The dividend will be paid August 1 to shareholders of record as of July 6.

Shares of the drug development company were up more than 1 per cent early Wednesday, at $34.98 on the New York Stock Exchange.

Wed, 27 Jun 2012 09:59:00 -0400
<![CDATA[News - Bristol-Myers posts Q4 rise in profit, but falls short of Street views ]]> Bristol-Myers Squibb (NYSE:BMY) Thursday reported a 76 percent increase in fourth-quarter earnings due to sales of a diabetes drug and hefty charges last year, but still missed Street estimates.

For the quarter that ended December 31, net income rose to $852 million, or 50 cents per share, up from $483 million, or 28 cents per share a year earlier.

Adjusted income rose 12 percent to $906 million, or 53 cents per share, from $807 million, or 47 cents per share, for the same period of 2010.

Total sales increased seven percent to $5.45 billion from $5.11 billion.

Analysts were expecting earnings of 55 cents per share on sales of $5.51 billion, according to FactSet.

The company focused attention on rapid sales growth for its three-year-old oral diabetes drug Onglyza, which saw sales increase 110 percent to $153 million.

The New York-based company said fees and discounts under the US health care overhaul reduced earnings per share by four cents in the latest quarter.

The year-earlier results were weighed down by $324 million in expenses, including charges for streamlining global operations, depreciation and shutdown costs, licensing payments and a tax charge.

Bristol-Myers said it expects 2012 full-year earnings per share between $1.90 and $2.00. Analysts are looking for $1.98 per share, on average.

Bristol-Myers and French partner Sanofi (NYSE:SNY) jointly market blood thinner Plavix, the world's second-best-selling drug, which posted a three percent drop in sales to $1.67 billion in the latest quarter.

The drug loses US patent protection in May, and Bristol has initiated a dozen or more partnerships and deals aimed at developing new revenue-generating products.

Among the most highly anticipated of those drugs is the anti-clotting pill Eliquis, which is approved in the European Union for preventing clots in patients getting hip or knee replacement surgery.

Bristol and its partner on the drug, Pfizer (NYSE:PFE), are seeking US approval for the drug for stroke prevention, which would allow them to market it for millions more patients.

The Food and Drug Administration has given Eliquis a priority review, with a March 28 target date for a ruling.

Also due to lose patent protection in 2012 is blood pressure drug Avapro. Sales of that drug and its foreign counterpart Avalide fell 23 percent, to $195 million.

Sales of the company's second biggest product, schizophrenia and bipolar drug Abilify, rose four percent to $737 million.

For full-year 2011, the company earned $3.71 billion, or $2.16 per share, on sales of $21.24 billion. Excluding one-time items income was $2.28 per share.

Thu, 26 Jan 2012 11:45:00 -0500
<![CDATA[News - Bristol-Myers, AstraZeneca say FDA needs more data for diabetes drug ]]> Drug makers Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) said Thursday that US health regulators need more data to better assess the benefit and risks for their experimental drug dapagliflozin.

The Food and Drug Administration issued a complete response letter regarding the two drug makers new drug application.

In that letter, the FDA asked for more clinical data to facilitate a better assessment of the benefit risk profile for dapagliflozin, which includes on-going studies and stated that it may possibly require new clinical trials.

Bristol-Myers and Astra Zeneca are seeking approval of the drug as an adjunct to diet and exercise for improving glycemic control in adults suffering from Type 2 diabetes.

AstraZeneca's main focus is on the discovery of medicines for gastrointestinal, cardiovascular as well as respiratory and inflammation, among others. It operates in over 100 countries.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover and develop innovative medicines that help patients prevail over serious diseases.

Both companies said they would work closely with the agency to ascertain the next steps for their drug application. The two companies also said that they are in on-going discussions with health authorities in Europe and other countries as part of the application procedures.

Bristol-Myers Squibb and AstraZeneca said they remain committed to dapagliflozin and its development.

The drug is used for the treatment of adult type 2 diabetes. It is an inhibitor of sodium glucose cotransporter-2 that increases renal glucose elimination and allows more sugar to be excreted with urine, reducing the amount in circulation.

Type 2 diabetes accounts for approximately 90 to 95 percent of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic, progressive disease characterized by insulin resistance and dysfunction of beta cells in the pancreas, which
decreases insulin sensitivity and secretion, leading to elevated glucose levels.

Last July 2011, a panel of expert advisers to the FDA recommended dapagliflozin not be approved due to safety hazards.

The panel cited elevated rates of bladder and breast cancer that were reported in clinical trials.

Then in October, the FDA delayed its target date for a decision on dapagliflozin by three months, saying it needed the time
to review additional data the companies had submitted from late-stage clinical trials of the drug. The new target date had
been January 28, 2012.

Bristol-Myers stock fell 3.17 percent reaching a low of $32.66 each, while AstraZeneca dipped to $47.53 per American Depository Share.

Thu, 19 Jan 2012 13:24:00 -0500
<![CDATA[News - Bristol-Myers Squibb to acquire Inhibitex for $2.5 bln ]]> Bristol-Myers Squibb (NYSE:BMY) announced over the weekend that it will acquire biopharmaceutical company Inhibitex (NASDAQ:INHX) in a deal valued at $2.5 billion, sending Inhibitex shares up over 150 percent in pre-market trading Monday.

Shares of the company, which is currently focused on its anti-hepatitis C (HCV) drug, rose 150.76 percent, or $14.83, to $24.70, as of 7:41 am ET this morning.

Under the terms of the agreement, Bristol-Myers Squibb will pay $26 in cash for each share of Inhibitex, way up from the company's $9.87 closing price on Friday.

Inhibitex's board has already agreed to the deal, and shareholders representing 17 percent of the company have entered into agreements in support of the offer.

"This transaction puts INX-189 and the company's other infectious disease assets in the hands of an organization that can more optimally develop them and which believes as strongly as we do in INC-189's potential in the treatment of chronic HCV," said Inhibitex president and CEO, Russell Plumb.

The INX-189 drug is an orally administered inhibitor of the polymerase that promotes the growth of HCV. It is currently in phase two development, but has already exhibited strong anti-viral activity.

Chief scientific officer for Bristol-Myers Squibb, Dr. Elliot Sigal, added: "Bristol-Myers Squibb continues to drive advances in the field of hepatitis C research and development through internal development and selective partnerships.

"The addition of Inhibitex's nucleotide polymerase inhibitor to our own promising portfolio, which includes other direct-acting antivirals, brings additional options to develop all-oral regimens with better cure rates, shorter duration of therapy and lower toxicity than the current standard of care."

Bristol-Myers Squibb said it will fund the transaction through its current cash resources. It expects the acquisition to be dilutive to its earnings through to 2016, including a four-cent per share impact in 2012, and a five-cent per share impact in 2013.

Mon, 09 Jan 2012 09:00:00 -0500
<![CDATA[News - Bristol-Myers' liver cancer drug fails to meet main goal of phase 3 study ]]> Bristol-Myers Squibb Co. (NYSE:BMY) said after markets closed Thursday its investigational drug brivanib for liver cancer failed to meet its main goal of improving overall survival versus placebo in a phase three study.

The double-blind study, which is one of four phase three clinical trials evaluating brivanib in different liver cancer patient populations, tested the drug on patients who have failed or are intolerant to sorafenib, the liver cancer drug co-developed by Bayer AG and Onyx Pharmaceuticals (NASDAQ:ONXX).

Bristol-Myers said it will still continue its other ongoing phase three studies for the drug as planned.

"The treatment options for patients with hepatocellular carcinoma following failure of sorafenib are limited, and thus we are disappointed that the primary endpoint was not met," senior vice president Brian Daniels said in a statement.

"We remain committed to the development of brivanib as a potential treatment option for patients with liver cancer."

Brivanib is an oral anti-tumour drug that inhibits receptors involved in the growth of cancerous cells. The drug has been investigated in 29 studies that have included more than 4,000 patients around the world.

Hepatocellular carcinoma is a cancer of the liver, and accounts for most liver cancers. This type of cancer occurs more often in men than in women. The disease is more common in parts of Africa and Asia than in North or South America and Europe.

Bristol is advancing a portfolio of compounds that aim to address unmet medical needs across the liver disease field, which includes hepatitis C, hepatitis B and liver cancer.

Shares of the company closed Thursday at $35.09 each in New York. Its shares edged down slightly early Friday.

Fri, 23 Dec 2011 09:52:00 -0500
<![CDATA[News - Bristol-Myers, Gladstone ink three year research collaboration deal ]]> Bristol-Myers Squibb Co. (NYSE:BMY) has inked a three year research collaboration deal with Gladstone Institutes to find targets that affect a key protein tied to Alzheimer’s disease which could lead to new therapies. 

The drug maker said it plans to fund Gladstone Institutes research efforts to identify targets that affect Tau dysfunction, a protein which binds the cell’s internal skeleton and may help regulate the activity of brain cells, in Alzheimer’s.

Financial terms and conditions were not mentioned in Thursday’s press release.

Gladstone’s director of neurological research, Lennart Mucke, said: "This partnership should enable us to translate our scientific discoveries more quickly into solutions that alleviate the suffering of Alzheimer’s patients and their families around the world."

Bristol-Myers Squibb senior vice president of discovery, Francis Cuss, said: "We are hoping that the scientific innovation in drug development will lead to a better understanding of the role of Tau in Alzheimer’s and potentially lead to the identification of new therapies."

The protein forms abnormal deposits called neurofibrillary tangles, a hallmark pathology of the disease. By identifying targets that prevent or reverse Tau dysfunction, Bristol-Myers Squibb and Gladstone hope to identify novel therapeutic strategies to modify the course of the disease.

Gladstone is a non-profit biomedical-research organization dedicated to accelerating the pace of scientific discovery and innovation to stop illness and cure patients suffering from cardiovascular disease, neurological disease and viral infections.

Bristol-Myers Squibb is a biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

Thu, 22 Dec 2011 15:30:00 -0500
<![CDATA[News - Bristol-Myers Squibb inks deal to develop anti-Hep C drug combo ]]> Bristol-Myers Squibb (NYSE:BMY) Friday entered into a deal with Tibotec Pharmaceuticals to develop jointly develop their Hepatitis C (Hep C) drugs.

The company agreed to enter into a clinical collaboration agreement with Tibotec to develop its own investigational drug daclatasvir (BMS-790052) in combination with Tibotec's investigational TMC435 drug, in the treatment of Hepatitis C (Hep C).

Under the terms of the agreement, Bristol-Myers Squibb and Tibotec, which is part of the privately-held Janssen Pharmaceutical group of companies, will evaluate the potential of their combined drugs to achieve a sustained anti-viral response for 12 weeks after treatment, and for 24 weeks after treatment, in patients suffering from Hep C.

Patients enrolled in the study will receive either: a once-daily oral dose of daclatasvir and TMC435, and a pegylated-interferon alpha and ribavirin, two common antiviral treatments for Hep C, or a once-daily oral dose of daclatasvir, TMC435, with ribavirin, or a once-daily oral dose of daclatasvir and TMC435 alone.

Bristol-Myers Squibb said it expects the study to start in the first half of 2012.

Bristol-Myers Squibb's senior VP of development, Brian Daniels, said: "Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like Hep C.

"We are pleased to work with Tibotec to advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals, which would be an important advancement for patients with Hep C.

"This is a continuation of our leadership in forging partnerships to advance combination antiviral therapy."

Caused by the virus of the same name, Hep C is an infectious disease affecting the liver. Chronic infection can lead to several complications, including scarring of the liver, liver failure, and liver cancer.

The daclatasvir drug works to inhibit the replication of the protein responsible for the virus. The drug, which Bristol-Myers Squibb said it discovered using a genometric approach, is the first of its kind to be investigated in clinical trials, where it is currently undergoing a phase three study.

In New York, Bristol-Myers Squibb shares rose 0.61 percent to $33.10, as of 10:03 am EDT.

Fri, 02 Dec 2011 10:28:00 -0500
<![CDATA[News - Bristol-Myers, Pfizer announce phase 3 trial for Eliquis fails to meet main goals ]]> Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE:PFE) announced Monday the results of their phase three Adopt trial, which failed to show that blood clot drug Eliquis, or apixaban, was superior in efficacy to enoxaparin.

The placebo-controlled trial tested apixaban versus enoxaparin in acutely ill medical patients, and did not meet  the primary efficacy outcome for the endpoint of venous thromboembolism (VTE) and VTE-related death at day 30.

"Solving the problem of VTE post-hospitalization remains a critical unmet need in preventing medically ill patients from developing deep vein thrombosis and pulmonary embolism,” said Dr. Samuel Z. Goldhaber, senior cardiologist at Brigham and Women’s Hospital, and Professor of Medicine, Harvard Medical School.

"ADOPT provides important insights for clinical trialists designing studies of extended duration VTE prophylaxis among medically ill hospitalized patients."

VTE encompasses two serious conditions: deep vein thrombosis, a blood clot in a vein, usually in the leg that partially or totally blocks the flow of blood; and pulmonary embolism, a blood clot blocking a vessel in the lungs, which carries the risk of sudden death.

The apixaban arm in the study had a 13 percent lower rate of events than enoxaparin, followed by placebo, but this was not statistically significant and thus "no clinically directive conclusion can be drawn", the companies said.

The key safety measure of major bleeding was low in both groups, but happened in more patients treated with Eliquis than those treated with enoxaparin.

The study results were presented at the annual American Heart Association (AHA) Scientific Sessions in Orlando, FL, and published in the New England Journal of Medicine.

Eliquis is currently approved in the EU for the prevention of VTE in adult patients who have undergone elective total hip or knee replacement surgery.

Adopt was a phase three, multi-centre, randomized, double-blind, controlled study. When apixaban was compared to enoxaparin, the primary efficacy endpoint occurred in 2.71 percent of patients in the apixaban group and 3.06 percent of patients in the enoxaparin group, showing a non-significant relative risk reduction.

Both Bristol and Pfizer recently announced the regulatory application for Eliquis for stroke prevention in atrial fibrillation, which was validated for review by the European Medicines Agency. The alliance expects to have an accepted filing in the U.S. for this indication by the end of 2011.

In 2007, the two companies entered into a worldwide collaboration to develop and commercialize Eliquis, an investigational oral anti-coagulant discovered by Bristol-Myers.

Bristol-Myers shares were down around 0.85 percent, while Pfizer shares fell 0.95 percent Monday. 

Mon, 14 Nov 2011 16:00:00 -0500
<![CDATA[News - Bristol-Myers inks alliance with Aslan to build-on cancer drug ]]> Drug maker Bristol Myers Squibb (NYSE:BMY) and privately-held Aslan Pharmaceuticals have struck an alliance to develop a drug to treat solid tumours. 

The partnership, which was announced on Thursday, did not disclose any financial terms or conditions.

According to the pact, Asia-based Aslan gets exclusive rights to develop and sell BMS-777607 in China, Australia, Korea, Taiwan and other selected Asian countries, while Bristol-Myers keeps exclusive rights for the rest of the world.  

Under a pre-agreed development program, Aslan is set to develop BMS-777607 that would target both gastric and lung cancers.

Aslan’s chief executive Carl Firth said: "This ground-breaking partnership demonstrates how a leading Asian drug development company can work together with a global biopharmaceutical company to accelerate drug development and conduct early clinical studies in Asia in areas of significant unmet need."

In a statement, Bristol-Myers senior vice president, Francis Cuss, said: "Partners like Aslan run and fund early development, working closely with Bristol-Myers Squibb, to produce high-quality data that may be used to further develop and commercialize the medicine worldwide."

The New York-based company gained 49 cents, or 1.57 percent, to reach $31.66 a share Thursday mid afternoon, on the New York Stock Exchange.

Thu, 03 Nov 2011 15:05:00 -0400
<![CDATA[News - Drug maker Bristol-Myers Squibb inks protein rights deal with Ambrx ]]> Drug maker Bristol-Myers Squibb (NYSE:BMY) said on Thursday that it has inked an agreement with privately-held biopharmaceutical company Ambrx for exclusive rights to commercialize and to develop biologics based on Ambrx’s research. 

The deal is tied to the Fibroblast Growth Factor 21 protein, for potential use in treating type 2 diabetes as well as the Relaxin hormone aimed at treating heart failure.

Bristol-Myers Squibb Senior VP Francis Cuss said: "Bristol-Myers Squibb has a strong heritage developing and delivering medicines to treat diabetes and cardiovascular disease."

"As part of our String of Pearls strategy we seek to build relationships with companies that have innovative programs and capabilities that complement our own internal efforts."

Under the terms, Bristol-Myers Squibb will make an upfront payment of $24 million to Ambrx. Further, the drug maker will make potential milestone and royalty payments on worldwide sales as well as enter research collaborations. 

FGF-21 is a naturally occurring protein that has been characterized as a potent metabolic regulator, and has been shown to lower blood glucose, elevate good cholesterol and promote weight loss in preclinical studies and is in the final stages of preclinical development.

Relaxin is a naturally occurring hormone known for its role in pregnancy and childbirth. Preclinical studies suggest Relaxin may aid in the treatment of heart failure by improving cardiac function. This program is in preclinical development.

Ambrx said it plans to use the revenues derived from this partnership to grow its pipeline, which includes antibody drug conjugate programs.

The Princeton, New Jersery-based company’s stock lost 59 cents, or 1.91%, to $30.36 a share Thursday afternoon.

Thu, 22 Sep 2011 13:34:00 -0400
<![CDATA[News - Bristol-Myers Squibb and AstraZeneca achieve main goal in type 2 diabetes drug trial ]]> Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) announced today their phase 3b clinical trial, under their January 2007 collaboration to research, develop, and commercialize investigation drugs for the treatment of type 2 diabetes, achieved its primary endpoint.

In New York, Bristol-Myers Squibb's stock rose 0.93% to $30.24, while AstraZeneca's hiked 1.23% to $45.09 as of 11:43 am EDT.

The study examined the effect of adding a five milligram (mg) dose of Onglyza to an ongoing insulin therapy regime, as compared to the addition of a placebo. The endpoint of the study was the mean change from baseline in blood sugar levels.

The study's principal investigator, Dr. Anthony Barnett said: "Since many patients with type 2 diabetes will eventually require insulin, it is important to assess a compound's ability to be used in combination with insulin to manage blood glucose control over the long term."

The phase 3b, multi-centre, randomized, placebo-controlled, double-blind study enrolled 455 adult patients with type 2 diabetes who were receiving regular insulin treatments. The mean baseline level of blood sugar, at 24-weeks, was 8.7%.

The subjects received either 5 mg of Onglyza, in addition to insulin, or a placebo, in addition to insulin, once daily for 52 weeks.

At the end of the 52-week study, Onglyza addition reduced blood sugar levels by 0.75%, compared to a 0.38% reduction in the placebo group. The Onglyza group also reported a mean 0.8 kilogram change in body weight, compared to a 0.5 kilogram change reported in the placebo group.

Accounting for up to 95% of all cases of diabetes, type 2 diabetes is a progressive disease that affects approximately 300 million adults across the globe. Paired with the aging population and the growing trend of obesity, it is estimated that the prevalence of the disease will reach 440 million people by the year 2030.

Characterized by an insulin dysfunction in the pancreas, the disease causes frequent urination, increased thirst and hunger, and fatigue, and has also been linked to early-onset Alzheimer's disease.

To date, Onglyza has been approved in 66 countries, including the U.S., Canada, Mexico, India, Brazil, China, and 30 European countries, where it is intended as a once daily, 5 mg oral table does in adults.

The drug uses saxagliptin, an enzyme that slows the breakdown of hormones responsible for producing insulin to offset the amount of glucose, or sugar, that the liver produces and secretes into the blood after a meal.

Fri, 16 Sep 2011 11:58:00 -0400
<![CDATA[News - Bristol-Myers inks deal to allow access of generic HIV drug to Africa and India ]]> New Jersey-based Bristol-Myers Squibb (NYSE:BMY) announced on Tuesday that it has permitted a generic drug company to manufacture and sell its HIV treatment Reyataz in sub-Saharan Africa and India.

The drug maker has signed an agreement with Matrix Laboratories, a Mylan pharmaceuticals company, to produce generic versions of the HIV treatments atazanavir, the generic name for Reyataz, as well as didanosine and stavudine.

"The HIV treatment landscape has changed dramatically since 2001, when we first began our Global Access Program to help expand the availability of low-cost HIV medicines in the developing world," said president of Bristol-Myers Squibb, Frank Pasqualone.

"Atazanavir is an important component of HIV combination therapy and this agreement facilitates broader availability of the medicine to help ensure patients can access appropriate treatment regimens."

The immunity-from-suit agreement with Matrix Laboratories is the fifteenth agreement that Bristol-Myers Squibb has signed for its HIV medicines, and the fourth for atazanavir.

A key component to the deal is the inclusion of pediatric formulations of the medicines to support the treatment needs of children with HIV, the company said.

Matrix Laboratories will secure World Health Organization pre-qualification for all products covered by the agreement, including pediatric formulations of didanosine, and in the future, atazanavir powder formulation for pediatric use, as soon as Bristol-Myers Squibb's product is available.

The WHO pre-qualification allows organizations to buy medicines using funding from United Nations' agencies and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Shares of Bristol-Myers Squibb rose 12 cents, or 0.42% to $28.59 in late afternoon trading.

Pharamceutical company Bristol-Myers Squibb manufactures its products in the United States, Puerto Rico and eight foreign countries. The aim of the company's Global Access Program is to allow access to HIV medicines in impoverished regions impacted by HIV.

Tue, 28 Jun 2011 16:19:00 -0400
<![CDATA[News - Bristol-Myers, AstraZeneca achieve main goal of type 2 diabetes drug study ]]> Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) found their combination drug to treat Type 2 diabetes was more effective than each of the components in the drug used alone.

According to the companies, the dapagliflozin plus metformin extended-release compound  achieved a signficant reduction in blood sugar levels in adults with previously untreated Type 2 diabetes in two phase II studies, compared to either dapagliflozin or metformin alone.

As a result, the studies, which were designed to test the safety and efficacy of the dapagliflozin-metformin compound, each produced top line results.

The drug combination also achieved better results for the secondary goal of the trials, which was a decrease in total body weight.

All candidates for the studies had blood sugar levels between 7.5% and 12%, while an average, or healthy, glycemic index control is considered between 4% and 6%.

Type 2 diabetes, which accounts for between 90% and 95% of all diabetes patients, is a disease characterized by insulin-resistant cells in the pancreas, causing elevated glucose levels.

"These studies showed that dapagliflozin as an initial combination therapy with metformin XR helped manage blood sugar levels and other measures of glycemic control in adults who previously had not been treated for type 2 diabetes," said medical director of research for PharmQuest, the investigator of the study, Alexander V. Murray.

Bristol-Myers Squibb and AstraZeneca said the new drug application for dapagliflozin was accepted for review by the FDA.

Mon, 27 Jun 2011 11:55:00 -0400
<![CDATA[News - Bristol-Myers Squibb To Buy Rights To Potential HIV Treatment Drug For $286 Million ]]> New York-based Bristol-Myers Squibb (NYSE: BMY), said today that it has agreed to buy the rights to a potential HIV treatment drug, Festinavir,  for $286 million from privately-held Japanese biotech firm Oncolys BioPharma. 

Under the agreement, Oncolys may receive up to $286 million including upfront, development, regulatory and sales milestone payments. Oncolys will also receive royalties on the worldwide product sales.

Festinavir, currently going through Phase II testing, can be taken orally.  The companies said early preclinical studies suggest that Festinavir could have an improved safety profile over previous generations of drugs.  The drug was originally licensed to Oncolys by Yale University. 

Bristol Myers shares are up by about 2 cents to trade at $26.51 as of 11:02 am EST.

Mon, 20 Dec 2010 16:14:00 -0500
<![CDATA[News - Bristol-Myers signs over anti-cancer compound rights in China to Simcere Pharmaceutical ]]> Global biopharmaceutical company Bristol-Myers Squibb (NYSE: BMY) has given China-based Simcere Pharmaceutical (NYSE: SCR) the rights to develop preclincal compound BMS-817378, a drug targeted for the treatment of advanced cancers, in its home country.

Under the terms of the agreement, Bristol-Myers Squibb will retain the rights in all other markets. Both parties have yet to determine the development plan, which will initially be performed by Simcere. The first-in-human studies will be conducted in China.

Bristol-Myers said the partnership between the two companies is an entirely new approach to devleoping its early-stage pipeline.

Simcere manufactures and sells anti-infective medication, anti-cancer medication and stroke management medication.

Wed, 03 Nov 2010 15:00:00 -0400