ELN Conference Call

I am focusing on only the Tysabri aspects of the ELN conference call. 

AAB-001 has moved from Phase 1 to Phase 2 clinical trials. This was new information for me (I’ve been out of the loop for awhile). This is an Alzheimer’s drug which has potential to be a bigger blockbuster than Tysabri because it has a much larger market. This drug is far from approval, but it’s good to keep this in mind if you are planning on investing in ELN longterm.

The FDA is expected to rule on the Tysabri sBLA, which was granted priority review, by the end of March. There will be a FDA commitee on March 7 which will discuss Tysabri risks, PML, efficacy, risk management, and possible remarketing plans. Patients will be able to speak at this committee, which is great news for shareholders because patients are very passionate about Tysabri’s return. In fact, I get a lot of encouraging emails from MS patients who have read my analysis of the Tysabri situation.

Their current financial model is based on the assumption that Tysabri will be remarketed in Q2 2006. AND, the model includes the assumption that Tysabri is expected to launch in the EU in the 2nd half of 2006!! This is HUGE news for me because Tysabri has never been available in the EU, which will greatly increase the number of patients who can access the drug.

BIIB, Biogen Idec, has been continuing to ramp up production capacity as well! There has also been advancement in the high-titer process, which I discussed a few months ago.

A BLA for Tysabri’s treatment of crohns disease will be filed immediately if the FDA rules favorably on Tysabri’s sBLA for MS. This will also increase the market for Tysabri.

My speculation on Tysabri still stands. I believe that the reviews will show that PML cases only arise from patients who are immunosuppressed, and that risk for PML can be controlled by monitoring patient’s immune system activty.

Don’t forget to check out my past analysis of Tysabri and ELN.

DISCLAIMER: If you haven’t noticed yet, I’m long on ELN.