Momenta Pharmaceuticals, Inc. (MNTA)

[indigokid]

Been reviewing the CP and have to say the FDA did a lot of work on this response. 43 pages with a good portion of that as footnotes and references to the 8 CP's from Teva. The FDA also developed its own testing methods one with 1000 data points. The technical and analytical skills of MNTA for approval are certainly impressive and clearly challenged the capabilities of the FDA. I don't have the technical skill to determine whether the FDA has provided a road map similar to enoxoparin, but it appears to be just a summary of publicly available info from the court documents, teva patents etc. While tough to say for sure it appears that the FDA hasn't given anything away, but has clearly shown that the technical bar is quite high and requires a large number of technical analytical tests at each step of manufacturing to show fingerprint like sameness.

My off the cuff estimate is that MNTA has several years before competitors meet the analytical and technical requirements. Since the FDA developed its own testing method with 1000 data points, as opposed to relying on a MNTA patented method, it's likely we won't have a safe harbor issue like enox. If so, the manufacturing patents may work as planned to provide significant entry barriers for competitors.