Momenta says FDA review of M-Enoxaparin still in progress, awaits outcome of patent litigation case

By Jennifer Lanning Drey

Eugene, Ore., Aug. 11 - Momenta Pharmaceuticals, Inc. said the Food and Drug Administration's review of its abbreviated New Drug Application for M-Enoxaparin is ongoing, while patent litigation regarding Lovenox also continues.

M-Enoxaparin is a technology-enabled generic version of Lovenox that is Momenta's most advanced product candidate. The company submitted an aNDA for M-Enoxaparin last August.

Lovenox is a low-molecular-weight heparin with seven approved indications for the prophylaxis and treatment of thromboembolic disease.

Richard Shea, chief financial officer of Momenta, told investors at the Banc of America Specialty Pharmaceuticals Conference on Friday that Momenta believes its generic version is likely to gain FDA approval.

But he did not provide a timeframe for when approval might expected.

Shea said Momenta believes it has the analytical technology to prove its drug is chemically equivalent to Lovenox - a factor that has been a hurdle for companies seeking approval of generic versions of Lovenox in the past, he said.

"Our technology, we believe, has a strong potential to obtain FDA approval," Shea said.

Still, even if approved, the company will not be able to launch a generic version of Lovenox until an appeals court decides whether sanofi-aventis' patent for the drug is enforceable.

A hearing on the matter will begin on Oct. 10.

"We believe it's highly likely the patent will be overturned. It's really just a question of the method by which it's overturned and the timetable it takes to overturn the patent," Shea said.

Momenta has a U.S. partnership for M-Enoxaparin with Sandoz, the generics business of Novartis.

The companies also recently announced another agreement in which they will collaborate on the development of four follow-on and generic versions of recombinant biotechnology and complex drugs, including one late-stage compound from Momenta's pipeline and two late-stage compounds from Sandoz.

"This is a great deal for Momenta. This takes the technology forward and it takes it from heparins to other complex mixtures to follow-on biologics," Shea said.

Momenta is a Cambridge, Mass.-based biotechnology company specializing in the characterization and engineering of complex drugs.

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