M356 is designed to be a generic version of Copaxone® (glatiramer acetate), 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).


Under our 2006 collaboration with Sandoz, Momenta and Sandoz agreed to jointly develop, manufacture, and commercialize M356, among other products. Characterizing Copaxone represents another significant technical challenge for generic manufacturers given its complex mixture of polypeptide chains of various lengths and sequences. Momenta is addressing this challenge with our core characterization and process engineering capabilities to develop and manufacture M356. The ANDA for M356 is currently under FDA review.



Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.


Last revised 10/18/2013