Momenta Copaxone Generic Delayed by CMO Warning

Feb. 23, 2017

Momenta's three-times-weekly version of Glatopa is unlikely to be approved this quarter due to a manufacturing issue at contract manufacturing plant that Novartis uses to fill the syringes with the drug.

Momenta and Novartis' Sandoz are currently collaborating on the development and commercialization of a generic version of three times weekly Copaxone 40mg/mL. Earlier this month, a U.S. district court ruling invalidated four patents on Teva's multiple sclerosis therapy, opening the door for a generic version of the 40mg formulation.

According to an article posted on Motley Fool, Momenta believes the application could theoretically gain FDa approval soon, but the contract manufacturing plant, which is owned and run by Pfizer, received a warning letter from the FDA. Pfizer will have to fix the problems cited in the warning letter before Momenta and Novartis can receive FDA approval.