Tuesday, June 17, 2008

Alzheimer's relief?

Well, vindication is sweet.

I've been singing Elan's praises for over 2 years now -- starting at around $13 a share in early 2006. (Too bad I didn't see it in 2005 for $3 a share!!!)

If you haven't seen the news (although early news items were unwarrantably negatively slanted) one of the more even-handed articles is shown as a link below.

http://www.reuters.com/article/marketsNews/idINL1769229220080617?rpc=44

If you don't want to wait for it -- basically Elan's Phase II Alzheimer's Disease trial results (the summary info, at least) were released today -- full details will be released at the ICAD meeting in late July. (ICAD is the International Conference on Alzheimer's Disease).

Those results show that based on a gene, you could be helped a great deal by this drug, called AAB-001. People who do NOT carry the APOE gene had improvements in cognition (on two different scales) and also improvements in daily function. The gene carriers did not meet statistical significance. That isn't the whole story, either, as some who carry the gene encountered Vasogenic Edema -- temporary swelling within the brain -- and left the trial, which hurt the trial as they still counted against the participants in the study.

Elan had seen interim data last summer and based off that peek, started a Phase III trial which kicked off December of 2007.

That Phase III trial has two cohorts with carriers and two cohorts with non-carriers (one of each in the US and one external to the US). Each cohort has 1000 patients expected to be enrolled -- and the carrier group has a lower dosing amount scheduled to see if that helps the VE.
Largely unknown at this point, all cohorts are EACH powered to be a pivotal trial by the FDA, and after 6 months of safety data, Elan could file a BLA (biologic license application) for the drug.

I have several other points about Elan (Tysabri, nanotechnology, $3B of losses to carry forward, Ireland's favorable tax treatment of royalty income, multiple other Alzheimer's treatments in the works) but for now -- I truly hope for AD patients that this moves forward, and quickly.

This post is dedicated to my maternal grandfather, Carl H. Carlson, who suffered from Alzheimer's.

Regards,
Trond

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