Momenta Pharmaceuticals Announces Filing of Abbreviated New Drug Application

CAMBRIDGE, MASS - Momenta Pharmaceuticals Inc. announced in a press release that the US Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for a generic version of Copaxone (glatiramer acetate injection), submitted by Sandoz Inc., Momenta's development and commercialization partner for this product.

"Advancing the M356 program for the development of a generic version of Copaxone is one of Momenta's top priorities, and we are pleased that the ANDA has been accepted for review," President and CEO of Momenta Craig Wheeler said.

Copaxone is indicated for the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis. Teva Pharmaceutical Industries Ltd. reported US sales of $1.1 billion for Copaxone for the twelve months ended 2007.

Momenta Pharmaceuticals is a biotechnology company specializing in the detailed characterization and engineering of complex drugs.