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To: Terry Maloney who wrote (163471)	5/2/2002 5:17:26 PM
From: reaper	Read Replies (2) \| Respond to of 436258

yes, i do follow Biogen. no, its not "make or break" in the same way it was for SEPR or ICOS, as Biogen has other drugs. that said, Biogen's Avonex (for MS) franchise is under attack from Rebif of Serono. Avonex lost its orphan drug status in the US recently, so Serono recently launched Rebif in the US -- Rebif was a big success in Europe. There is some clinical data that suggests that Rebif is better than Avonex (though it should be noted that that data is from Serono and not from some independent 3rd party; the FDA has denied Serono the right to claim clinical superiority in its labeling). So the long and short of it is that Biogen's main franchise, which is a $billion-ish drug, is under serious attack. So Biogen really needs Amevive (for psoriasis) to get approved and be a big hit. I personally don't think it will get the green light. Psoriasis is not life-threatening, but it is chronic, so you need to take the drug 'forever'. But the longer-term safety data on Amevive (and on Xanelim, the competing compound from Genentech & Xoma) is not really there (i.e. they don't really have "long-term" data yet as they haven't been testing over the "long-term"), as there are some questions regarding t-cell depletion. Plus the results, in terms of the number (%) of people that it helps are not that compelling. I mean, if you can keep 50% of refractory cancer patients alive for an extra year, then that is a drug worth approving. If you can keep 50% of people from having psoriasis..... (btw, that 50% success rate was for illustrative purposes only; I do not know the actual rate but have read it described as "not overly impressive"). You clearly have a skittish FDA right now, which is requesting "more data" on everything, and Biogen is going to present them with a drug for a non-deadly disease that you have to take chronically without really long-term safety data and with not-overly-impressive efficacy results. That does not seem to me to be the profile of a drug that will get approved. Cheers