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Momenta Says District of Delaware Invalidates Teva's MS Drug

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Shares of Momenta Pharmaceuticals, Inc. shot up 25.2% after Mylan N.V. announced that the U.S. District Court for the District of Delaware has issued a decision in favor of the latter pertaining to claims related to Teva Pharmaceutical’s (TEVA - Free Report) Copaxone 40mg/mL. This news is a positive for Momenta as well, as the company, along with Novartis’ (NVS - Free Report) generic arm-Sandoz Inc., is looking to get approval for their generic version (Glatopa 40 mg ) of 40-mg thrice-weekly formulation of Copaxone.

The invalidated patents are United States Patent Numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva.

Earlier, in Dec 2016, the U.S. Patent and Trademark Office's U.S. Patent Trial and Appeal Board (PTAB) reaffirmed a prior decision that three of these patents ('250, '413 and '302) are unpatentable in its inter partes review (IPR) proceedings initiated by Mylan. In addition, Mylan also challenged the '776 patent in an IPR proceeding. The PTAB is expected to issue its institution ruling on the '776 patent IPR by Apr 2017.

Further, shares of Momenta have performed better than the Zacks categorized Medical-Biomedical and Genetics industry in the past one year with the stock gaining 50.1% compared to the industry’s decline of 9%.

Coming back to Momenta – the company received a boost with the FDA approval of Glatopa 20 mg/ml (a generic version of Copaxone 20 mg) in Apr 2015. The company has a collaboration and license agreement with Sandoz for Glatopa and Enoxaparin Sodium Injection. The company earned a $10 million milestone from Sandoz upon Glatopa’s FDA approval and another $10-million milestone upon the first commercial sale of Glatopa. Momenta is also eligible to receive up to $120 million in milestone payments from Sandoz upon the achievement of certain regulatory, commercial and sales-based milestones for Glatopa. Momenta has recorded $715 million in product revenues as well as regulatory and commercial milestones related to Glatopa and Enoxaparin Sodium Injection until Sep 30, 2016.

On the other hand, Teva is expected to face continued sales erosion for Copaxone due to increased competition. The generic market is highly crowded and Teva faces competition from players like Mylan, Dr. Reddy's Laboratories Limited and Sandoz among others.

 

Zacks Rank & Key Picks

Momenta currently carries a Zacks Rank #2 (Buy), while Teva carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

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