Momenta Pharmaceuticals, Inc., a biotechnology company, focuses on developing generic versions of complex drugs, biosimilars and novel therapeutics for oncology and autoimmune disease. Complex Generics Programs GLATOPA—Generic COPAXONE (glatiramer acetate injection) 20 mg/mL GLATOPA is a generic version of once-daily COPAXONE 20 mg/mL indicated for the treatment of patients with relapsing-remitting multiple sclerosis, a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. COPAXONE is available in both a once-daily 20 mg/mL formulation, which is approved by the United States Food and Drug Administration (FDA), and a three-times-weekly 40 mg/mL formulation, which was approved in 2014. COPAXONE is marketed in the United States by Teva Neuroscience, Inc., a subsidiary of Teva Pharmaceutical Industries, Ltd. GLATOPA was approved by the FDA in April 2015 and was launched in June 2015. GLATOPA is a substitutable generic equivalent of once-daily COPAXONE. GLATOPA is developed and is being commercialized in collaboration with Sandoz AG (Sandoz), the generic pharmaceuticals division of Novartis. Under the company’s collaboration agreement with Sandoz, Sandoz is responsible for commercialization of GLATOPA. M356—Generic Three-times-weekly COPAXONE (glatiramer acetate injection) 40 mg/mL M356 is the company’s generic product candidate for three-times-weekly COPAXONE 40 mg/mL. M356 is being developed for commercialization in the United States in collaboration with Sandoz. The company’s application seeking approval of M356 was filed by Sandoz in 2014 and is under review by the FDA. The company’s M356 formulation contains the same active pharmaceutical ingredient as GLATOPA. Enoxaparin Sodium Injection—Generic LOVENOX Enoxaparin Sodium Injection is a generic version of LOVENOX indicated for the prevention and treatment of deep vein thrombosis and to support the treatment of acute coronary syndromes. LOVENOX is marketed in the United States by Sanofi. The company’s Enoxaparin Sodium Injection was developed and is being commercialized in the United States in collaboration with Sandoz. Sandoz is responsible for commercialization of Enoxaparin Sodium Injection. Biosimilars Programs M923—Biosimilar HUMIRA (adalimumab) Candidate M923 is being developed as a biosimilar of HUMIRA. HUMIRA is a monoclonal antibody that could bind to a substance in the body known as tumor necrosis factor (TNF), thereby inhibiting the known effect of TNF as a potent mediator of inflammation. HUMIRA is indicated for the treatment of patients with rheumatoid arthritis, Crohn's disease, ulcerative colitis and psoriasis, among other diseases. HUMIRA is approved in 13 indications worldwide and 9 indications in the United States. HUMIRA is marketed by AbbVie worldwide. M923 is being developed and commercialized in collaboration with Baxalta U.S. Inc., Baxalta GmbH and Baxalta Incorporated (collectively, ‘Baxalta’). The company is responsible for development activities through submission of an Investigational New Drug application (IND) to the FDA, or equivalent application in the European Union, and Baxalta is responsible for clinical development, manufacturing and commercialization activities. In February 2015, Baxalta commenced a randomized, double-blind, single-dose study in healthy volunteers to compare the pharmacokinetics, safety, tolerability and immunogenicity of M923 versus EU-sourced and the U.S.-sourced HUMIRA. In December 2015, the company announced that M923 met its primary endpoint in the study as the data demonstrated pharmacokinetic bioequivalence to the reference products. In October 2015, Baxalta initiated a pivotal clinical trial in patients with chronic plaque psoriasis for M923. The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA. Baxalta is planning to submit the first regulatory submission for marketing approval for M923 in 2017, and subject to marketing approval and patent considerations, the company expects first
momenta pharmaceuticals inc
675 West Kendall Street
Cambridge, MA 02142
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