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In yesterday's investor conference call, BiogenIdec (co-sponsor of Tysabri along with Elan, who has a similar call scheduled for Thursday), provided a brief but positive update on the status of Tysabri. - The safety review of the trial patients is still on track to be completed by the "end of the summer." Happily, they finally defined what "end of summer" meant to them: September 21st! - After conclusion of the safety review, they will commence discussions with the regulatory bodies on how to bring Tysabri back to the market in terms of label changes, additional testing, etc. - During the previous quarter, Biogen spent $20M USD to cover the cost of Tysabri production (!) and to develop a high-titre production process (essentially, a more efficient process for producing Tysabri) - In a new development, Biogen/Elan are taking initial steps to begin re-dosing patients who had previously been on Tysabri clinical trials, as well as beginning additional trials as had been previously planned prior to the discover of PML. - Biogen does not feel that these trials will be required for bringing Tysabri back to the commercial market (Very important!). Part of the reason for this is that, prior to suspension, there were already post-marketing trial commitments in place, not all of which Biogen had been able to commence. - Previous studies (Phase II) showed that patients who were taken off of Tysabri treatment had relapses begin recurring after about 6 months-- though there was no rebound above the level seen in the placebo patients. Therefore, the FDA will theoretically be aware that MS patients in the Tysabri trials before the marketing suspension are reaching the point where they should begin relapsing. As such, there is a sliver of hope that re-dosing of former Tysabri clinical trial patients could begin by early September 2005. To be clear-- This is SPECULATION. However, note that it is easier to restart clinical trials then it is to re-introduce the drug to the general market. Click "read more" for a link to a recording of the call...

Posted by Administrator on Wednesday, July 27 @ 12:22:53 EDT (84 reads) (Read More... | 2529 bytes more | comments? | Score: 4)