Data announced in October represent the first fruits of Momenta Pharmaceuticals Inc.'s novel drug pipeline, which will play a larger role in the company's strategy going forward as it steps back from complex generics.
Momenta was founded in 2001 to develop a platform technology to analyze complex carbohydrate molecules that are beyond the reach of conventional methods of characterization. By using the technology to solve what had been scientifically intractable problems, the company hoped to build a portfolio of complex generics, novel drugs and biosimilars - all of which would be insulated from competition by either IP or know-how created by the platform.
The science turned out to be the easier part, at least compared with navigating regulatory hurdles related to product approvals and patent law. The biotech persevered through a five-year regulatory review for its generic enoxaparin, only to see a competing generic by Amphastar Pharmaceuticals Inc. and Actavis plc cut into revenues. Momenta sued but was unable to defend its IP.
Momenta's second product, a generic equivalent of Copaxone glatiramer, has been held up by litigation as well. A patent infringement lawsuit filed by Teva Pharmaceutical Industries Ltd.against Momenta and partnerSandoz has prevented FDA from approving an ANDA that was submitted seven years ago. Sandoz is the generics unit of Novartis AG.
The U.S. Supreme Court has agreed to hear the case, with a ruling expected in June 2015.
In addition to those difficulties, the realization that Momenta's technology needed to be retooled to develop a generic Copaxone product, and would need to be retooled again to pursue each additional complex generic, led the company to conclude complex generics were not scalable.
As a result of all