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ImmuPharma rolling on rapidly with Lupuzor

Lupuzor is not the only part of the Immupharma story and McCarthy plans also to raise the profile of the rest of the group's early stage pipeline in 2016.....
ImmuPharma rolling on rapidly with Lupuzor
Lupus is much more common in women...

Any doubts in the market about drug developer ImmuPharma's (LON:IMM) progress should have been laid to rest by recent news from the group.

It has successfully raised £8.4mln to fund the development of potential blockbuster Lupuzor and reached the milestone of physically dosing patients for the phase III clinical trial of the drug, for the treatment of auto-immune disease Lupus.

Management had been concerned that the message of where the Lupus III trial was heading was not getting through, but the latest activity should allay these fears, it hopes, and close the disparity between the firm's current share price and the potential commercial value of the drug.

Shares surged to around 30p in early December when it announced it was ready to recruit patients, but have subsequently fallen back to around the 25p mark.

Chairman Tim McCarthy had told investors in December: "There is now nothing to stop us completing the study."

He also outlined the rigorous and time-consuming preparation that has to be gone through even to get to that milestone.

In all, 200 Lupus sufferers will be brought on and the aim is to complete the trial by the end of 2017 with top line results then.

Then the commercialisation process and all important sales start coming into view.

For McCarthy, it has been a process to inform the market of where the drug development firm is going.

"I think the difficulty for ImmuPharma in the last six to 12 months has been a big uncertainty about where the Lupus phase III trial was going," he said last year.

"They (the market) can now see that it's progressing positively and that's where the value's going to come."

Dr Mike Mitchell, at broker Panmure Gordon, seemed to agree in his latest analysis. The pharma and biotech expert is targeting a price of 150p for the shares of the £18mln AIM firm - five times where they are now.

As long-standing Proactive Investors readers will know, the road to reach this point has been long and not uneventful.

ImmuPharma did have full rights to the drug but licensed them to US pharma Cephalon, when the pair entered an option agreement in 2008, but then it exercised its right to take them back again when Cephalon was taken over by Israeli drug maker Teva.

In an unconventional move, rather than go with a tie-up with a traditional pharma firm, Immupharma opted to outsource the phase III trial work to contract research organisation (CRO) Simbec-Orion.

So, as McCarthy points out it's highly unusual for a small biotech like ImmuPharma to still own all the rights to its drug at this late phase III stage, but that does mean its full grip on the potential value of the candidate should mean the returns, when they come, will be sweeter.

As mentioned, Lupuzor has "blockbuster" potential, which means under the pharma industry's own definition, a drug which could sell at US$1bn or more a year, so it's probably worth looking now at what Lupus is and who is affected by it.

Systemic Lupus Erythematosus (SLE) is a debilitating and painful disease, which sees the body's immune system turn against itself for reasons still not fully understood.

It can affect various organs in various people in various ways so many symptoms can ensue, which calls for treatment from heart, liver and skin specialists.

It is much more common in women, appears most often in African-Americans, Asians and Hispanics and it is estimated that up to five million individuals worldwide may be affected.

McCarthy does not claim Lupuzor is a cure but he hopes that it will offer significant relief to sufferers such that their quality of life is greatly improved.

It also works better than other products available, he says, such as Glaxo's Benlysta, as it interacts with the body in a "different way" and at a "higher level" and also offers fewer side-effects.

The end of a successful trial will herald the start of applying to sell the drug and McCarthy, though not yet decided on the exact process, is clear that a partner or partners to sell the drug worldwide would be required at that point. Immupharma is "not a marketing company", he says.

Although certainly the main value driver, Lupuzor is not the only part of the Immupharma story and McCarthy plans also to raise the profile of the rest of the group's early stage pipeline in 2016.

Of its five lead compounds, it also has a cancer product called IPP-204106, which the group is preparing to look at going into phase II studies.

And the group has early innovative research going on with Centre National de la Recherche Scientifique (CNRS), Europe’s largest fundamental research institution and ImmuPharma’s long standing collaboration partner which McCarthy describes as really "quite exciting".

"That connection is very important for us. We have very close ties with the CNRS and that has given us a lot of potential product development for the future as well," he says.

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