Replies to post #79208 on Biotech Values

[DewDiligence]

MNTA: In fall of 2007, I believe FDA issued a non-approvable letter to MNTA based on their concern of not enough information provided with regard to immunogenicity. Is it remotely possible that FDA is not fully onboard with Enoxaparin based on this concern and would still ask for verification of clinical safety?

Possible but not likely, IMO. In Apr 2008, NVS/MNTA submitted to the FDA an outline of the companies’ intended response on the immunogenicity question, and the FDA concurred with the companies’ approach; NVS/MNTA then submitted the actual response in Sep 2008:

http://sec.gov/Archives/edgar/data/1235010/000110465908060599/a08-24340_18k.htm

Momenta Pharmaceuticals… announced that on September 26, 2008 its collaboration partner, Sandoz Inc., a division of Novartis, submitted to the U.S. Food and Drug Administration an amendment to Sandoz’ Abbreviated New Drug Application (“ANDA”) for Enoxaparin Sodium Injection. The Company believes the ANDA amendment to be a complete response to the FDA addressing the potential for immunogenicity of the drug product.