Biotech Values

[DewDiligence]

Re: Thrice-weekly (40mg) Copaxone

From a practical standpoint, I don’t think it makes much difference whether thrice-weekly Copaxone is reviewed by the FDA as an NDA or sNDA; in either case, if the product is approved, doctors will have to explicitly prescribe the thrice-weekly dose and Teva will have to do a lot of detailing to convince them to do it.

I expect thrice-weekly Copaxone to garner at most 15-20% of the US Copaxone market (#msg-77016146), which is a much lower share than Teva’s own book-talking projection and the projections of some sell-side analysts who are bullish on Teva.

Moreover, although I’m not actually predicting a CRL, it would not surprise me if the FDA issued a CRL for Teva’s sNDA in order to see the full safety database from the open-label extension of the GALA study. Thrice-weekly Copaxone uses a higher dose and 2x higher concentration than regular Copaxone and it confers no medical benefit, so it would make sense for the FDA to be cautious with respect to product safety.