M-Enoxaparin
Our most advanced product candidate, M-Enoxaparin is enabled by our technology and our understanding of complex sugars. It is designed to be 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). Sanofi-Aventis reported worldwide sales of Lovenox of approximately $2.7 billion in 2005, with approximately $1.6 billion coming from the United States.
Our ability to sequence and analyze complex mixtures of sugars has allowed us to analyze Lovenox and develop a process that we believe can be used to make a generic version of Lovenox that will meet the FDA requirements for ANDA approval. We have collaborated with Sandoz to jointly develop, manufacture and commercialize M-Enoxaparin in the U.S. and, more recently, the European Union.
M-Dalteparin
M-Dalteparin is designed to be a technology-enabled generic version of Fragmin (dalteparin), the second largest selling LMWH product in the United States. Fragmin is currently marketed by Eisai Inc. in the United States, by Pfizer in Europe and by Kissei Pharmaceutical Co., Ltd. in Japan. The product is indicated for the prevention of DVT and selected indications in ACS.
As with M-Enoxaparin, we believe our ability to sequence and analyze complex sugars will allow us to analyze Fragmin and demonstrate that our generic product has the same active ingredients as Fragmin, thereby enabling ANDA regulatory approval.
Other Complex Mixtures
We are also exploring the application of our technology to the development of generic versions of drugs that are complex mixtures. Complex mixture drugs are composed of molecules that, due to their diversity, are difficult to fully characterize. Heparins and glycoproteins are two examples among many complex mixture drugs; however, while heparins contain only sugars, glycoproteins are made up of both proteins and sugars. Our objective is to enable a better understanding of existing complex mixture drugs to facilitate the development of equivalent versions of these products.
Glycoproteins are a major class of complex mixture drugs. Sales of the top 10 glycoproteins are approximately $20 billion. Due to technical limitations in the analysis of these drugs and the lack of an FDA approval pathway, there are no follow-on or generic versions of glycoproteins currently on the market. We believe that as technology — such as that of Momenta — provides improved characterization of these complex molecules, this may facilitate an abbreviated approval pathway for follow-on or generic versions of these drugs.
Our pipeline of technology-enabled generic and follow-on versions of other complex mixtures include:
- M356 — Technology-enabled generic version of a major marketed complex mixture drug. We are developing, manufacturing and commercializing M356 in collaboration with Sandoz.
- M178 — Follow-on version of a major marketed protein therapeutic. The development, manufacture and commercialization of M178 is in collaboration with Sandoz.
- M249 — Follow-on version of a major marketed protein therapeutic. The development, manufacture and commercialization of M249 is in collaboration with Sandoz.