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.<
NEW YORK/LONDON, Nov 6 (Reuters) - U.S. regulators have rejected Momenta Pharmaceuticals Inc's (MNTA) generic version of Sanofi-Aventis SA's top-selling thrombosis drug Lovenox, sending Momenta shares into a tailspin and Sanofi climbing.
Momenta said on Tuesday its partner, Sandoz, received a letter from the U.S. Food and Drug Administration saying its application for the product, M-Enoxaparin, was not approvable. Sandoz is the generic drugs division of Novartis AG .
Momenta said the FDA's letter indicated that M-Enoxaparin was rejected because the application did not adequately address concerns about effects on the immune system.
The FDA recommended in its letter that Momenta and Sandoz meet with the agency to determine what additional information should be provided to address this concern.
The news is a major blow for Momenta. The U.S. group had appeared ahead in the race to sell a copy of Lovenox, Sanofi's biggest medicine, which had worldwide sales of 1.94 billion euros ($2.82 billion) in the first nine months of 2007.
Sanofi shares rose 3.9 percent while Momenta opened 46 percent lower on Nasdaq. Novartis shares were little changed.
SECOND BULLET DODGED
It is the second time this year that France's Sanofi, the world's third largest drugmaker, has dodged a bullet from generic competition, after the U.S. patent on its Plavix blood thinner was upheld in June.
"This removes a significant sentiment overhang for Sanofi-Aventis and allows investors to focus on 2008 with significant clinical newsflow coming up, at what we see as an unchallenging valuation," Deutsche Bank analyst Michael Leuchten said in a note.
Lovenox accounts for up to 15 percent of Sanofi's net profits but, in practice, industry analysts had not expected Momenta's generic to win business easily. That is because Lovenox is a large, biological molecule that must be given by injection and is not straightforward to substitute.
Leuchten said a substitutable generic Lovenox now looked increasingly unlikely. There is another generic challenger waiting in the wings, from Teva Pharmaceutical Industries Ltd (TEVA) and Amphastar Pharmaceuticals, but Momenta is generally thought to have the better technology.
Momenta said it was working with Sandoz to address the FDA's questions and determine the information necessary to win approval of M-Enoxaparin.
The FDA's reluctance to clear Momenta's generic version of Lovenox may signal a wider conservatism towards so-called biosimilar medicines, or copies of biotech products.
If so, that could be good news for other companies with important branded biotech drugs in their portfolios, such as Amgen Inc (AMGN) and Roche Holding AG . (editing by John Wallace/Elizabeth Fullerton)
Market Data 
Markets 
AI
