Momenta announces filing of FDA application

Momenta Pharmaceuticals Inc., a Cambridge biotechnology company, announced today that the Food and Drug Administration has agreed to review the an abbreviated new drug application, or ANDA, for a generic version of Copaxone.

Copaxone is used to reduce the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis, and the ANDA application was submitted by Sandoz Inc., Momenta's development and commercialization partner for this product, Momenta said.

Sandoz is the generics division of Swiss drug giant Novartis AG, and Momenta has been working with Sandoz to make generics of brand-name biologic drugs in Europe.

Advancing the "program for the development of a generic version of Copaxone is one of Momenta's top priorities, and we are pleased that the ANDA has been accepted for review," Craig A. Wheeler, Momenta's president and chief executive, said in a statement.

Momenta cited third-party data that US sales for Copaxone were $1.1 billion last year.

Momenta said it has scheduled a conference call this morning to discuss the submission of this application.

One of Momenta's cofounders is Christoph Westphal, also cofounder of another Cambridge biotech, Alnylam Pharmaceuticals Inc.

Westphal is currently chief executive of Sirtris Pharmaceuticals Inc., another Cambridge biotech. In April, British pharmaceuticals giant GlaxoSmithKline PLC announced plans to buy Sirtris for $720 million.
(By Chris Reidy, Globe staff)