Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

Excerpts from WSJ Blog -

“It’s a very complex product and not easy to duplicate,” says Craig Wheeler, the Momenta executive. “But we view this as an endorsement of our technology.”

Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, took pains to note the generic Copaxone “met the same rigorous standards of quality as the brand-name drug. Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.”

Wheeler....declined to discuss [launch] timing, but indicated the companies are ready to launch. He adds that the appeals court set an accelerated date for review, suggesting that a decision could occur in coming weeks.

LEERINK analyist....believes the success that Teva is having switching patients is incentive to risk a launch before the key Copaxone patent expires.

Wheeler says that “it will be priced significantly lower than the brand [Copaxone] to get that incentive for pharmacies and [health] plans to switch [to the generic]. When asked about price, he would only say that, “typically, we see discounts in the 30% range… It’s a reasonable ballpark to start.” He notes that the list price for the older version of Coxapone is about $72,000 per patient a year.

http://blogs.wsj.com/pharmalot/2015/04/16/fda-approves-generic-copaxone-but-when-will-it-become-available/