Harold,
I was at the panel meeting in Gaithersburg. In my opinion, there weren't any real surprises out of the meeting. We had expected the data to be a bit less convincing than ours, but that they would ultimately get a recommendation. There was clearly agreement among the panel members that the data did not support an effect of Copaxone on progression of disability and the exacerbation rate reduction was around 23% (vs 30% plus for AVONEX and Betaseron). While safety was not a major issue, there was quite a bit of head-scratching over the 15% of patients that get a side effect that Teva termed a 'self-limiting syndrome' which included chest pain or tightness and flushing; no-one knew what might be causing the 'syndrome' but there was no data suggesting it was particularly dangerous. It is also important to note that Copaxone caused injection site reactions in more than 75% of patients. These are not the kind of reactions that patients get with Betaseron...much more benign...but they occurred with a much greater frequency than injection site reactions with AVONEX (4% of AVONEX patients).
Also, the strategy that Teva seems to be taking, gleaned from comments by the lead Copaxone clinical investigator (Dr. Wolinsky, Houston) is not too surprising. Apparently Teva plans to try to position Copaxone as the alternative to interferons, and/or first-line therapy in early patients.
They'll do this mostly by trying to lump Betaseron and AVONEX together, labeling them the 'mean, nasty interferons that cause injection site necrosis and lose efficacy over time due to neutralizing antibodies' while suggesting that Copaxone doesn't have any ofthese problems. I don't think they'll be successful since neurologists are rapidly becoming aware that the significant problems with Betaseron aren't as bad with AVONEX (no injection site necrosis, less frequent flu-like symptoms, lower levels of antibodies that don't appear to affect efficacy). So I think they'll find it an uphill battle if they march into the neurologists offices and give them that pitch.
As for first line therapy, I'll just say that it seems kind of counterintuitive that patients who are less sick (and thus much less tolerant of significant lifestyle intrusion) would choose an every-day therapy over one that is once per week (AVONEX) which has very clear data showing it slows the progression of disability.
Net net, the recommendation happened as expected and we are anticipating Teva will be on the market in several months (about as we've always expected, despite Teva's pronouncements that they would be approved this summer). One could argue that Teva/Marion being on the market might even help us, since the increased marketing 'noise' may drive more patients into therapy. (And it appears that we're getting the vast majority of new patients initiating therapy.)
Thanks for the question.
Rick Lundberg
Biogen Investor Relations |
