Key Developments: Momenta Pharmaceuticals Inc (MNTA.OQ)
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1 Aug 2013
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Latest Key Developments (Source: Significant Developments)
Teva Pharmaceutical Industries Ltd Update On COPAXONE Litigation Filed By Momenta Pharmaceuticals, Inc./Sandoz Inc. And Mylan Laboratories Inc./Natco Pharmaceuticals
Teva Pharmaceutical Industries Ltd announced that the U.S. Court of Appeals for the Federal Circuit has affirmed the judgment of the U.S. District Court for the Southern District of New York in the appeal filed by Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals regarding the validity and infringement of four patents for Teva`s relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE (glatiramer acetate injection) that expire in May 2014. The appellate court, however, reversed the trial court and declared other patents expiring in May 2014 and one patent expiring in September 2015 to be invalid. The appellate court specifically ruled that asserted claims of these patents are invalid for being indefinite. Teva Pharmaceuticals Ltd. filed suit against Momenta Pharmaceuticals Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals for infringement of multiple patents covering the chemical composition of COPAXONE, methods of using the product and processes for manufacturing the product, the latest of which expires on September 1, 2015. July 26, 2013 decision maintains exclusivity for COPAXONE until May 24, 2014. Teva is disappointed with the court`s decision with respect to four of the 2014 patents and the 2015 patent and will appeal on July 26, 2013`s decision. Full Article
Momenta Pharmaceuticals, Inc. Announces Decision in Teva Patent Litigation
Momenta Pharmaceuticals, Inc. announced that the District Court for the Southern District of New York has issued a decision in the patent litigation brought against Momenta by Teva in August of 2008. The court found all the claims infringed and not invalid or unenforceable. The decision is subject to appeal. Full Article
Baxter International Inc. And Momenta Pharmaceuticals, Inc. Announces Collaboration To Develop And Commercialize Follow-On Biologics
Baxter International Inc. and Momenta Pharmaceuticals, Inc. announced that they have entered into a global collaboration to develop and commercialize follow-on biologic products, also known as biosimilars. Biosimilars replicate existing, branded biologics used in the treatment of a variety of diseases including cancer, autoimmune disorders and other chronic conditions. Under the terms of the agreement, Baxter will make an upfront cash payment of $33 million to Momenta related to the collaboration for up to six follow-on biologic compounds. Baxter may make additional payments over the next several years for the development of the compounds, contingent upon the achievement of technical, development and regulatory milestones with respect to all six products. Full Article
Momenta Pharmaceuticals, Inc. Acquires Assets From Virdante Pharmaceuticals
Momenta Pharmaceuticals, Inc. announced that it has signed an agreement to acquire the Sialic Switch assets of Virdante Pharmaceuticals, Inc., including intellectual property and cell lines, relating to the sialylation of intravenous immunoglobulin (IVIG) and other proteins. Momenta made an upfront payment of $4.5 million and may make additional contingent payments, which, if all development and regulatory milestones are achieved, will total $51.5 million. Virdante, a venture-backed biotechnology company, was founded in 2008 to apply its Sialic Switch technology to develop novel therapeutic treatments for autoimmune and inflammatory disorders. Virdante's Sialic Switch technology is based on the principle of activating a novel anti-inflammatory pathway by specifically sialylating Fc-linked glycans of IgG antibodies. Full Article
District of Massachusetts Grants Request By Momenta Pharmaceuticals, Inc. And Sandoz Inc.
Watson Pharmaceuticals, Inc. confirmed that the United States District Court for the District of Massachusetts has granted a request by Momenta Pharmaceuticals, Inc. and Sandoz Inc. for a temporary restraining order (TRO) preventing Watson and Amphastar Pharmaceuticals, Inc. from marketing or selling Amphastar's Enoxaparin Sodium Injection product, a generic equivalent to Sanofi-aventis' LOVENOX. The temporary restraining order expires on October 21, 2011. In entering the TRO, the court made no finding concerning plaintiffs' likelihood of success on the merits of their claim. A hearing on Momenta and Sandoz's motion for a preliminary injunction is expected to be held on October 20, 2011. Watson expects to launch the product during the fourth quarter of 2011 if the request for a preliminary injunction is denied. Full Article
Watson Pharmaceuticals, Inc. And Momenta Pharmaceuticals, Inc. Confirms Amphastar Patent Lawsuit
Watson Pharmaceuticals, Inc. announced that Momenta Pharmaceuticals, Inc. and Sandoz Inc. have filed suit against Amphastar Pharmaceuticals, Inc. and Watson on September 21, 2011 in the United States District Court for the District of Massachusetts . The suit alleges that Amphastar's Enoxaparin Sodium Injection product, which Watson has the exclusive right to distribute in the U.S. retail pharmacy channel, infringes Momenta's U.S. Patent Nos. 7,790,466 and 7,575,886. Enoxaparin Sodium Injection is a generic equivalent to Sanofi-aventis' LOVENOX. Watson and Amphastar intend to vigorously defend the claims in the lawsuit. Pursuant to terms of the distribution agreement between Watson and Amphastar, Watson believes it will be fully indemnified by Amphastar for all costs, expenses and damages, if any, incurred in connection with the lawsuit. Full Article
Momenta Pharmaceuticals, Inc. Sues Amphastar for Patent Infringement
Momenta Pharmaceuticals, Inc. announced that it has sued Amphastar Pharmaceuticals, Inc., Watson Pharmaceuticals, Inc. and International Medical Systems, Ltd. in the United States District Court for the District of Massachusetts for infringement of two Momenta patents. The patents cover the Company's innovative methods of producing enoxaparin sodium, which assure that the commercial product meets standards for identity and quality. One patent, U.S. Patent No. 7,790,466, is related to methods of processing enoxaparin to determine the presence of certain tetrasaccharide structures. The second patent, U.S. Patent No. 7,575,886, is related to methods of analyzing enoxaparin for the presence of a certain structural signature. Full Article

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