Kick in the teeth for MNTA's business model. If they can't satisfy the FDA that they adequately characterized Enoxarin (a generic version of low molecular weight heparin, a small glycosaminoglycan), then they are in trouble.
I hope they release more specific details about what concerned the FDA. It could be that the FDA objected to the formulation used to package Enoxarin.
NSTK's Calcitonin ANDA was rejected because the FDA said that using chlorobutanol as a preservative might lead to immunogenicity, although NSTK had seen no signs of allergic reactions in their tests, and other nasal drugs formulated with chlorobutanol have been approved. In NSTK's case, a Citizen's petition was filed with the FDA bringing up the possibility of immunogenicity and asking for further testing. Have Citizen's Petitions been filed in an effort to block MNTA's product? It's a simple delaying tactic.
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.<
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