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Momenta-Sandoz's Generic Copaxone Accepted for Review by FDA

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Momenta Pharmaceuticals (MNTA) announced that the FDA has accepted partner Sandoz’s, a Novartis (NVS) company, abbreviated new drug application (ANDA) for the generic version of Teva Pharmaceutical Industries Ltd.’s (TEVA) three-times-a-week Copaxone (M356; 40 mg/mL) for review.

Momenta expects the generic version of Copaxone to be available in the first quarter of 2017. It believes that it is the first company to file an ANDA for the generic version of Copaxone and should be entitled to 180 days of generic market exclusivity in the event of the FDA clearing the ANDA.

Copaxone is approved for the treatment of patients suffering from relapsing-forms of multiple sclerosis. Currently, Momenta's generic version of the 20 mg/mL formulation of Copaxone is also under FDA review as a high priority ANDA.

Moreover, Momenta stated in its press release that the 40 mg/mL formulation of generic Copaxone contains the same substance as the 20 mg/mL formulation. Hence, the company expects the review process for both formulations to be completed within the same time frame.

We remind investors that in Oct 2013 Teva’s petition to the U.S. Court of Appeals for the Federal Circuit related to Copaxone patents was rejected. Meanwhile, the U.S. Supreme Court agreed to hear Teva’s appeal of a decision from the Court of Appeals for the Federal Circuit. The Supreme Court will hear the case in Oct 2014. A verdict from the Court should be out by the end of 2014/first half of 2015.

We expect investor focus to remain on updates on the FDA action related to Copaxone’s ANDA.

Momenta carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Gilead Sciences Inc. (GILD), carrying a Zacks Rank #1 (Strong Buy).

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