Momenta Gets Some Mojo As FDA Agrees To Review Application of Generic MS Drug

Xconomy Boston — 

Shares of Cambridge, MA-based Momenta Pharmaceuticals rose more than 11 percent today after the FDA agreed to review an application filed by its partner, Sandoz, to sell a generic version of Copaxone, a billion-dollar drug for multiple sclerosis.

Momenta, (NASDAQ: MNTA) doesn’t have any marketed products of its own. So, naturally, the application to market a generic version of Teva Pharmaceutical Industries’ Copaxone is “one of Momenta’s top priorities,” said CEO Craig Wheeler, in a statement. Copaxone had $1.1 billion in U.S. sales last year, so the first company to come up with a generic version could grab a significant piece of the action.

Momenta’s stock rose 11 percent to $14.57 at 10:56 a.m. Eastern time after the announcement. Teva didn’t take the filing lightly. In a statement, it said its patents are still valid until 2014 and it intends to sue Momenta and Sandoz for patent infringement.

Jerusalem-based Teva, the world’s largest generic drugmaker, is arguing that Copaxone is a complex formulation and would be extremely difficult for anyone to copy. It’s a bit ironic, since that’s the same argument big biotech companies like Amgen and Genentech use to keep generic manufacturers like Teva from moving in on their turf. This could get interesting in the coming months over at FDA.