Biotech Values

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Momenta Pharmaceuticals Announces Receipt of FDA Letter -- M-Enoxaparin ANDA Not Approvable in Current Form
Company to Host Conference Call at 8:30 am Eastern Time

CAMBRIDGE, Mass., Nov. 6, 2007 (PRIME NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today 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.

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 characterization 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."