Momenta Pharmaceuticals, Inc., a biotechnology company, engages in the structural characterization, process engineering and biologic systems analysis of complex molecules, such as polysaccharides, polypeptides, and biologics (including proteins and antibodies). The company’s complex generics programs target marketed products that are approved by the United States Food and Drug Administration (FDA) as New Drug Applications. Product Programs—Complex Generics and Biosimilars Enoxaparin Sodium Injection—Generic Lovenox The company’s commercial product, Enoxaparin Sodium Injection, is a generic version of Lovenox. Lovenox is a complex drug consisting of a mixture of polysaccharide chains and is a prescribed low molecular weight heparin used for the prevention and treatment of deep vein thrombosis and to support the treatment of acute coronary syndromes. Lovenox is distributed worldwide by Sanofi-Aventis U.S. LLC (Sanofi-Aventis) and is also known outside the United States as Clexane and Klexane. The company has a collaboration and license agreement, or the 2003 Sandoz Collaboration, with Sandoz N.V. and Sandoz Inc. (collectively, ‘Sandoz’) to jointly develop, manufacture, and commercialize Enoxaparin Sodium Injection in the United States. Sandoz N.V. assigned its rights in the 2003 Sandoz Collaboration to Sandoz AG, an affiliate of Novartis Pharma AG. M356—Generic Copaxone (glatiramer acetate injection) M356 is designed to be a generic version of Copaxone (glatiramer acetate injection), a complex drug consisting of a synthetic mixture of polypeptide chains. Copaxone is indicated for the reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis, a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. Under the Second Sandoz Collaboration Agreement, the company and Sandoz AG agreed to collaborate on the development and commercialization of M356. Biosimilars Program The company is also applying its technology platform to the development of biosimilar versions of marketed therapeutic proteins, with a goal of obtaining FDA designation as interchangeable. In 2012, the company and Baxter (Baxter International, Inc.; Baxter Healthcare Corporation; and Baxter Healthcare SA) entered into a collaboration and license agreement under which it agreed to collaborate, on a worldwide basis, on the development and commercialization of approximately six biosimilars. Product Candidates—Novel Products M402 M402 is a novel heparan sulfate mimetic that binds to multiple growth factors, adhesion molecules, and chemokines to inhibit tumor angiogenesis, progression, and metastasis. The use of heparins to treat venous thrombosis in cancer patients has generated various reports of antitumor activity. In 2012, the company initiated a Phase 1/2 proof-of-concept clinical study in patients with advanced metastatic pancreatic cancer. Collaborations and Licenses The company has an agreement with the Massachusetts Institute of Technology granting the company various exclusive and non-exclusive worldwide licenses, with the right to grant sublicenses, under certain patents and patent applications relating to methods and technologies for characterizing polysaccharides; certain heparins, heparinases, and other enzymes; and synthesis methods. Strategy The company’s business strategy has been to develop both generic and novel products, and it is working with collaborators to develop and commercialize its complex generics and biosimilars. Research and Development The company’s research and development expense was $80.3 million for 2012. Patents and Proprietary Rights The company licenses or owns a patent portfolio of approximately 85 patent families, each of which includes United States patent applications and/or issued patents, as well as foreign counterparts to certain of the United States patents and patent applications. Competition The company’s competitors include Sanofi-Aventis; EMD Serono Inc., a subsidiary of Merck Serono, a division of Merck KGaA; Pfizer Inc.; Biogen Idec Inc.; Bayer HealthCare Pharmaceuticals Inc., the pharmaceuticals affiliate of Bayer Schering Pharma AG; Bayer Schering Pharma, a division of Bayer AG; and Novartis Pharmaceuticals Corporation. History The company was founded in 2001. It was incorporated in Delaware in 2001 under the name Mimeon, Inc. In 2002, the company changed its name to Momenta Pharmaceuticals, Inc.
momenta pharmaceuticals inc
675 West Kendall Street
Cambridge, MA 02142
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