Enoxaparin
Our first product is a generic version of Lovenox (enoxaparin sodium), a low-molecular-weight heparin product (LMWH). Lovenox is a complex mixture composed of thousands of distinct complex sugar chains. Lovenox is the most widely prescribed LMWH used for the prevention and treatment of deep vein thrombosis (DVT) and treatment of acute coronary syndromes (ACS).
Our ability to sequence and analyze complex mixtures allowed us to analyze Lovenox and develop a process that is used to make a generic version of Lovenox that met the FDA requirements for ANDA approval. We have collaborated with Sandoz to jointly develop, manufacture and commercialize enoxaparin in the U.S. It was approved and launched on July 23, 2010.
M356
Our next generic product candidate, M356, is designed to be a generic version of Copaxone (glatiramer acetate injection), a drug consisting of a complex mixture of polypeptide chains. Copaxone is indicated for the reduction of the frequency of relapses in patients with RRMS. Multiple sclerosis is a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. Copaxone and several interferon beta products are among the leading products marketed for treating multiple sclerosis.
Under our 2006 Sandoz Collaboration, we and Sandoz AG agreed to jointly develop, manufacture and commercialize M356. Given its structure as a complex mixture of polypeptide chains of various lengths and sequences, there are significant technical challenges involved in thoroughly characterizing Copaxone and in manufacturing an equivalent version. We believe our technology can be applied to characterize glatiramer acetate and to develop a generic product that has the same active ingredients as Copaxone.