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.
COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd. Glatopa® is a registered trademark of Novartis AG.
Last Updated 8/31/2016