Momenta Pharmaceuticals announces receipt of FDA letter
M-Enoxaparin ANDA not approvable in current form
Momenta Pharmaceutics Inc. (Nasdaq:MNTA) announced that its collaboration partner, Sandoz Inc. (Sandoz), a division of Novartis, had received a letter from the U.S. Food and Drug Administration (FDA) on November 5, 2007, stating that Sandoz abbreviated new drug application (ANDA) for Enoxaparin Sodium Injection is not approvable says a press release.
The FDA's letter stated that the ANDA was not approvable because the application does not adequately address the potential for immunogenicity of the drug product and recommended that Sandoz and Momenta meet with the Office of Generic Drugs to determine what additional information should be provided to adequately address this concern. Sandoz and Momenta are working together to identify the additional information that is necessary to obtain approval of the ANDA.
"In a follow-up call, the FDA clarified that all applications for enoxaparin products must address the potential for immunogenicity of the drug product. We believe that we can address what we anticipate to be the FDA's concerns, based on our detailed characterisation of enoxaparin and on the current medical and scientific literature," said Craig A. Wheeler, President and Chief Executive Officer. "Our path forward will be determined in conjunction with Sandoz and the FDA."
Momenta Pharma-ceuticals is a biotechnology company specialising in the detailed structural analysis of complex mixture drugs. Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs. The Company's most advanced product candidate, M-Enoxaparin is designed to be a technology-enabled generic version of Lovenox(r). Within the Company's discovery programme, it is seeking to discover and develop novel therapeutics by applying its technology to better understand sugars' functions in biological processes, with an initial focus in oncology.
Whereas this is the scenario in the developed world, in some third world countries like ours, Enoxaparin Sodium Injection is being produced, marketed and sold by some pharmaceutical companies.
Enoxaparin sodium, a low molecular weight heparin used to prevent and treat deep vein thrombosis and pulmonary embolism. In fact, it is an anticoagulant (blood thinner) that prevents the formation of blood clots. This medicine is used following knee or hip replacement surgery and following abdominal surgery in patients at high risk of developing a blood clot. Enoxaparin is also used with aspirin to prevent complications of certain types of angina and heart attacks, and with warfarin to treat deep vein thrombosis (a type of blood clot). The drug is a patent and research product of the Sanofi-Aventis pharmaceutical company, originating in France.
Since full molecular structure of Enoxaparin Sodium is not yet discovered and the patent is not open to produce its generic version, production and marketing of the drug by some other pharmaceutical companies may pose serious health risk of the critical patients eminent cardiologists of the country think alike. They urge the Drug Administration to consider the matter as a serious public health issue and take necessary steps.
Additional reporting can be found at Star Health published on December 10, 2006
Source: http://www.thedailystar.net/ 2006/12/10/d612106103108.htm
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