Achieving Substitutability in Complex Generics
Momenta's complex generic programs are designed to utilize the existing generic regulatory pathway for Abbreviated New Drug Applications, or ANDAs. We validated our approach to the development of highly complex generic molecules by becoming the first company to achieve regulatory approval of a generic version of Lovenox® (enoxaparin sodium injection). This FDA approved product, in collaboration with and marketed by Sandoz, is a complex mixture of polysaccharide chains derived from naturally-sourced heparin. Enoxaparin sodium injection is used to prevent and treat deep vein thrombosis and to support the treatment of acute coronary syndromes.
Our second major generic product candidate, M356, also in collaboration with Sandoz, is a generic version of Copaxone® (glatiramer acetate), a drug indicated for reducing the frequency of relapses in patients with relapsing-remitting multiple sclerosis. With M356, we have extended our core characterization and process engineering capabilities to include characterization of complex polypeptide mixtures. The ANDA for M356 is currently under FDA review.
Lovenox® is a registered trademark of Sanofi-Aventis. Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
Last revised 6/21/2012