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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-forms of multiple sclerosis (MS). Multiple sclerosis is a devastating chronic disease of the central nervous system characterized by inflammation and neurodegeneration.  COPAXONE is among the leading products marketed for treatment of patients with relapsing-forms of MS. 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 registered trademark of Novartis AG.

Last Updated 8/31/2016