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M356 (Generic three times weekly COPAXONE® 40mg)

M356 is designed to be a generic version of three times weekly COPAXONE 40mg (glatiramer acetate injection), a drug consisting of a complex mixture of polypeptide chains and indicated for reducing the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS). Multiple sclerosis is a devastating chronic disease of the central nervous system characterized by inflammation and neurodegeneration. RRMS, defined by inflammatory attacks on the protective coating of neurons (myelin) and characterized by intermittent bouts of symptoms, is the most common disease course at the time of diagnosis. COPAXONE is among the leading products marketed for treatment of RRMS. It works by stopping the body from damaging its own nerve cells (myelin).

We are developing and commercializing M356 in collaboration with Sandoz, a division of Novartis AG. Sandoz’s Abbreviated New Drug Application, or ANDA, for a three times weekly generic COPAXONE 40mg is under review by the FDA.

In April 2015 Momenta and Sandoz announced FDA approval to market Glatopa®, the first substitutable generic version of daily COPAXONE 20 mg.

 

COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd. Glatopa® is a trademark of Novartis AG.

Last Updated 1/4/2016