Tuesday, July 26, 2005

Tysabri Update from Biogen

i'm listening to the biogen Q2 call right now. there are no material developments, but the executives are very upbeat about the reviews. jim mullen, the CEO, said that it is too early to make any conclusions, but that the MS portion of the review is almost complete. i assume that the crohns patient reviews are the holdup. he has reiterated that reviews should be done "by the end of summer." jim mullen also stated that studies on PML have been very fruitful and that onset of PML can be detected and managed. the important inference to make here is that there have been no new confirmed PML cases! also, biogenidec is continuing to fund development on the high titer process for tysabri, which allows higher production capacity for the drug. according to the financial officer, peter, "we are assuming that tysabri is only temporarily suspended". the KEY point that one of the executives brought up is the restart of tysabri trials. he stated that in the coming weeks, biogen/elan could be in talks with the FDA and EU regulatory agencies to restart tysabri trials for MS patients. he is most likely referring to a restart of the tysabri 1808 ms trials. i continue to be very upbeat on the future of tysabri, and i'm looking forward to ELN's call on thursday. Significant Q/A Session Information -Someone asked biogen to confirm that there are 3 cases of PML, but biogen refused to comment because it is too early to make conclusions from the safety evaluations. Instead, he reiterated that Biogen intends to push the FDA and EU regulatory agency to allow MS Tysabri trials to restart. -The expenses associated with developing the high-titer process will create some additional charges in Q3, but they will be "continuing to produce Tysabri throughout the year." -Tysabri's sales team has been temporarily reassigned to pitch Avonex, but the sales force for Tysabri is still availible for the relaunch of Tysabri. -The executives made fun of the Boston Globe and WSJ during the call (they reported a 4th and 5th 'case' of PML last month). -Clinical trials might restart before commerical relaunch of Tysabri. Resuming clinical trials is more simple FDA-wise than a commercial relaunch because of potential labeling issues. -FINALLY!! THE END OF SUMMER HAS BEEN DEFINED! The exec during the Q/A threw out the date September 21st as their definition of the "end of summer." -"Have you guys sent the data to the FDA necessary to take the hold off trials" *silence* "No." *next question*. -JW

3 Comments:

Anonymous Anonymous said...

great analysis on your part. looking forward to the return of Tysabri.

7/26/2005 03:15:00 PM  
Anonymous Anonymous said...

Excellent summary John! I can't wait to see what Elan has in store for us Thursday.

7/26/2005 03:16:00 PM  
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10/25/2005 07:01:00 PM  

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