Momenta Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) seeking marketing approval of M-Enoxaparin with the United States Food and Drug Administration (FDA). Momenta is developing M-Enoxaparin, a technology-enabled generic version of Lovenox, in collaboration with Sandoz, the generics division of Novartis AG.
Approved for the prevention and treatment of deep vein thrombosis and treatment of acute coronary syndromes, Lovenox (enoxaparin sodium injection) is a widely-prescribed low molecular weight heparin. Sanofi-Aventis reported worldwide Lovenox sales of $2.4 billion in 2004.
"The ANDA for M-Enoxaparin is a major accomplishment for Momenta, representing the first application for marketing approval filed with the FDA based upon our technology," Alan Crane, CEO of the company said adding, "We believe that our proprietary approach to characterizing and sequencing complex sugars can be applied to both the development of generic versions of complex drugs as well as to the discovery and development of novel products based on sugars."
"We believe that our proprietary technology enables us to analyze the Lovenox mixture and demonstrate that M-Enoxaparin has the same active ingredients as Lovenox," said Crane.
Momenta Pharmaceuticals, Inc. is a biotechnology company specializing in the sequencing, or detailed structural analysis, and design of complex sugars for the development of novel drugs, the improvement of existing drugs and the discovery of new biological processes.