Tuesday, February 28, 2012

Does Anavex Life Sciences (AVXL) Have the Next Big Thing Big Pharma Wants?

If there's one thing big pharma has telegraphed in the last few weeks, it's a renewed willingness to spend big bucks to refill dying pipelines. As an example, Gilead Sciences, Inc. (NASDAQ:GILD) bought out Pharmasset, Inc. (NASDAQ:VRUS) in November for Pharmasset's hepatitis C treatment, followed by Bristol Myers Squibb Co. (NYSE:BMY) purchasing Inhibitex, Inc. (NASDAQ:INHX), also for its hepatitis C research. While the back-to-back buyouts put other hepatitis therapy companies in the spotlight as potential acquisition targets, that ship may have already sailed. The next big thing in biotech buyouts is more likely to be something from the Alzheimer's Disease realm, and that may well put a name like Anavex Life Sciences Corp. (OTC:AVXL) smack dab in the middle of a suitor's sites.

Anavex Life Sciences Corp. is a development-stage company, predominantly focused on the treatment of Alzheimer's Disease with its ANAVEX 2-73 drug, currently in Phase I trials as a treatment not just for Alzheimer's, but as a therapy for epilepsy and stroke as well. Like several other major pharmaceutical companies, AVXL is targeting the sticky clumps of amyloid beta protein that form in the brain and are generally linked with AD. Anavex Life Sciences is doing something different than many of its competitors, in that it's not looking for a way to remove the beta plaques once formed - an almost Herculean task whether or not the blood/brain barrier is a problem. Rather, AVXL is aiming to prevent their creation in the first place.

It's the kind of novel approach that Gilead Sciences and Bristol Myers Squibb probably wish they would have been taking all along with any of their in-house attempts at a hepatitis C treatment.

GILD was working on GS 9190, an increasingly popular (with the Hep-C treatment world) polymerase inhibitor that was being dosed with four other antiviral drugs. The co! mbo crea ted some adverse reactions, and though Gilead downplayed the problems that popped up in September, the fact that it and the FDA redesigned the trials is something of a red flag. Two months later, Gilead Sciences owned Pharmasset, Inc., making no bones about the fact that it wanted Pharmasset's drug... a drug that VRUS has said worked with 100% response rate. If Gilead had a winner, why pay a 30% premium for another company just for one drug?

Bristol Myers Squibb's is a similar story. Its BMS-790052 is a polymerase inhibitor plus a protease inhibitor (dosed with and without ribavirin and peginterferon), in Phase II trials. It also had three other HCV treatments in the works. Yet, it still felt the need to acquire Inhibitex, Inc. in January to get its hand on INX-189, which has showed promising results as a phase II hepatitis C drug.

Just to reiterate, both Bristol Myers Squibb and Gilead Sciences has their own Hep-C drugs in the worked, but the decided they liked someone else's better. Clearly size, experience, and resources didn't help either to the front of the R&D line.

Great, but what's this got to do with Anavex Life Sciences Corp. and Alzheimer's? Quite a bit, actually.

See, hepatitis was just one of many arenas where big pharma was barking up the wrong tree. They've been equally off the mark with cancer treatments (and cancer immunotherapy in particular), several auto-immune ailments, and yes, Alzheimer's Disease.

Eli Lilly (LLY) was steering one of the biggest AD letdowns to date. Its gamma secretase inhibitor semagacestat actually made patients Alzheimer's symptoms worse. Pfizer (PFE) and Elan (ELN) are following in the same gamma secretase footsteps, yet the same concerns that the Lilly trial raised have been raised for the Pfizer/Elan duo. And yes, Bristol Myers Squibb Co. is even forging ahead with a now-questionable gamma secretase inhibitor therapy. Even Wyeth's and Elan's phase III Bapineuzumab - which uses a different beta plaque ! removal mechanism to treat AD symptoms - is coming under fire as its actually efficacy is being requestioned; some expect it not to win approval.

So, with a couple of recent failures of Alzheimer's drugs that may be attacking a problem too late, one has to wonder if the same pattern is going to play out again - without an effective AD drug in their own pipelines, are some of the major pharmaceutical names going to go out and buy smaller companies to refill their pipelines?

If that's the case, than Anavex Life Sciences may look attractive simply because it's not wasted time pointlessly attacking the problem of amyloid beta plaque. Rather, it's developing an idea will head off the development of amyloid beta proteins at the pass. At least a few big pharma layers have to be saying to themselves "Why didn't we think of that?" ... kind of like Gilead and Bristol Myers Squibb did with hepatic C.

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