Tuesday, December 2, 2014

Celgene analysis and Biogen Idec Alheimers therapy

My latest analysis of Celgene (CELG) is at Seeking Alpha:

Celgene Stock Price: Is It Bubbly?

Biogen Idec (BIIB) announced today it plans a Phase III trial for an Alzheimer's Disease (AD) therapy. I just recently wrote in Biogen Idec, PML Deaths, And Hemophilia Therapies that I was not counting any of its Alheimer's pipeline in my valuation, which was basically positive. And I'm still not.

The interim data on BIIB037, an anti-amyloid beta MAB (antibody), Phase 1b randomized, blinded, dose-escalated study, for early-stage AD, showed safety and the removal of beta amyloid from the brain. Also patients were tested for cognition and nerve function. Removal of amyloid corresponded with dose size and time of treatment. At 54 weeks the effects on cog were positive and statistically significant. The study is not even done yet.

Biogen is planning a Phase III trial, but that would be dependent on finishing the trial and permission from the FDA.

I hope this will turn out to be true and Alzheimer's patients will at last have a therapy that works, if administered early enough. However, I have seen false positive signals before, followed by failures in Phase II and Phase III trials. Some scientists question the correlation of amyloid deposits to mental deterioration. Cognitive trials tend to be subjective, even if double blinded.

I believe it is too early to get excited, but of course I will take a close look at the full data when it is published.

And, as I said in my article, if this therapy helps or prevents progression in Alzheimer's patients, the revenue and profits from it would likely eclipse anything we have seen in pharmaceutical history.

Disclosure: I own stock in both BIIB and CELG.

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