Momenta : CAFC Invalidates Remanded Teva Patent In Daily Copaxone 20 Mg Suit

(RTTNews) - Momenta Pharmaceuticals, Inc. (MNTA) announced that the United States Court of Appeals for the Federal Circuit or "CAFC" has again found that U.S. Patent No. 5,800,808, related to a method of manufacturing glatiramer acetate, is invalid as indefinite.

"We are very pleased with the Federal Circuit's decision to declare Teva's manufacturing process patent invalid once again. we look forward to providing patients with a more affordable generic alternative for the treatment of multiple sclerosis," said Craig Wheeler, President and Chief Executive Officer of Momenta.

Once daily Glatopa (glatiramer acetate injection), developed in collaboration with Sandoz, is the first FDA-approved generic version of daily COPAXONE 20 mg for patients with relapsing forms of multiple sclerosis. Produced entirely in the United States, once daily Glatopa has been determined by the FDA to be therapeutically equivalent to daily COPAXONE 20 mg, and is an "AP" rated, fully-substitutable product.

As a therapeutically equivalent generic product, once daily Glatopa contains the same active ingredients, route of administration, strength, and dosage form, and can be substituted with the full expectation that Glatopa will produce the same clinical effect and safety profile as daily COPAXONE 20 mg. Daily COPAXONE 20 mg is one of the leading products marketed to treat multiple sclerosis, and is frequently prescribed as a first-line therapy in newly diagnosed patients.