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Big Pharmas Gamble On Risky Alzheimer's Treatments
Posted: Tuesday, June 19, 2012 7:25 PM
Joined: 12/6/2011
Posts: 3326

From Alzheimer's Daily News:

(Source: Investor's Business Daily) - One of the most common problems of old age - Alzheimer's disease - is still so mysterious that investing in it requires a biotech-like appetite for risk.


This year, Eli Lilly and Johnson & Johnson, and Pfizer and Elan will formally ask the Food and Drug Administration to approve their drug candidates for treating Alzheimer's disease. Both of them are in phase-three testing.


The problem is that based on their previous results, analysts don't give them high chances of success.


No one knows for sure what causes Alzheimer's disease, but both solanezumab and bapineuzamab were developed on the theory that beta amyloids are the culprit.


Lilly has already released one product based on this. Earlier this year it won approval for Amyvid, an injectable radioactive agent that helps physicians detect amyloid plaques via PET scan. On June 1, Lilly announced that Amyvid is now available in 16 U.S. markets, and that it would launch a training program for its use.


The company's previous drug candidate targeting beta amyloid, semagacestat, was shot down in 2010 after a phase-three trial found some patients' memories and functioning were actually getting worse. Lilly pressed on with solanezemub which targets beta amyloids in a different and possibly less dangerous manner.


Solanezumab is an antibody prevents amyloid clumps and plaques from forming. It is not believed to affect gamma secretase, spokeswoman Stephanie Prodouz explained.


Bapineuzumab is also an antibody, but in 2009, Elan had to cut the highest dose from its trial population when some patients had water retention in their brains, causing the possibility of swelling and inflammation.


Last month, the Obama administration announced a National Plan to Address Alzheimer's Disease, backed by a $156 million commitment to back research. As its first project, it chose to collaborate with Roche unit Genentech in a very early-stage study of its compound crenezumab.


Crenezumab is intended to actually prevent Alzheimer's from developing in the first place. But since you can't predict who will get the disease, prevention can be complicated. Genentech is going to be giving the drug to a large family in Colombia with a genetic marker tied to early-onset Alzheimer's. Over the years, it will be watching to see how the treated group compares to the placebo group.


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