Great deal? Desperation deal?
Compared to JNJ's steal of Epo from AMGN in the 1989's for $300 million chump change, when dow jones was approximately 3/8 of today's level, ELN's doesn't look too shabby considering it's not clear whether it will achieve the level of success that EPO did.
Back to Tysabri, I have 3 questions and would appreciate any input.
1. When the current weekly update on PML ceases in July, will BIIB/ELN have enough data to establish long-term tysabri PML rate?
2. Will NOvartis FTY720 or Merck's cladribine compete effectively with Tysabri?
3. What will it take to move Tysabri into first-line MS, eg a head-to-head trial of Tysabri vs Teva's Copaxone?
Here are my thoughts, comments welcomed:
Question 1, I think yes, because by my estimate they would have more than 7000 patients treated for 2 years, 4000 for more than 30 months, and 2500 for more than 3 years. Barring a significant influx of PML cases in the next 4 weeks, the lower-bound of the Kaplan Meier estimate at 36 months could easily clear the 1/1000 limit set forth by FDA.
Question 2, Tysabri wins on the benefit because it is the only disease modifying agent in that it's able to repair nerve damage. Assuming answer to question 1 is correct, the risk is in Tysabri's favor compared to NOVARTIS's FTY720 (PML vs skin cancer plus fatal infection), and compared to Merck's cladribine (PML vs malignancy).
Question 3, a partner that's not as interest-conflicted as BIIB. One would think the PML risk in the less immunocompromised first-line MS patient population should beat Copaxone on a properly chosen endpoint.
TIA
P3
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