12:00 AM
 | 
Dec 15, 2014
 |  BioCentury  |  Strategy

Momenta moving on

Why Momenta abandoning complex generics in favor of novel drugs and biosimilars

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 these factors, Momenta has concluded that complex generics are not a viable application of its technology, except perhaps in the context of a partnership.

Now the company will focus exclusively on its pipeline of novel drugs and biosimilars. The most advanced novel program, a heparin-derived candidate called necuparanib, will have Phase II data in pancreatic cancer in 2017. FDA approval could happen as early as 2018 if Momenta is able to file on the Phase II data.

Momenta expects to increase its clinical pipeline of novel drugs and biosimilars from one to three by YE15, six byYE16, and nine by YE17.

Heparin roots

Momenta spun out from the Massachusetts Institute of Technology with a method for analyzing sugar molecules that was pioneered by co-founders Ram Sasisekharan, professor of biological engineering at MIT, and CSO Ganesh Kaundinya.

The technology has three parts: a library of enzymes to break down carbohydrate sequences into smaller components; analytic tools to determine the arrangement of those components in the molecule; and mathematical modeling to characterize structure.

President and CEO Craig Wheeler told BioCentury Momenta always intended to develop novel drugs, but complex generics seemed to be a faster route to revenues.

"Our strategy was to take advantage of the shorter and less expensive development pathway in generics, and use our technology to differentiate our program from competitors and to generate earlier product revenues for the company, and we did this through the development of generic Lovenox," Wheeler said.

Lovenox enoxaparin from Sanofi and other low molecular weight heparins are produced by depolymerizing heparin, a complex mixture of polysaccharides...

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