cine circovirus type 2 vaccine. Merial plays an important role in veterinary public health activities of governments around the world. Merial offers vaccines for foot-and-mouth disease, rabies and bluetongue. Merial's principal markets are the United States, France, Brazil, Italy, the United Kingdom, Germany, China, Australia, Japan, Spain, and Canada. Marketing and Distribution The company has a commercial presence in approximately 100 countries and its products are available in approximately 170. The company markets majority of its products through its own sales forces. The company’s vaccines are sold and distributed through multiple channels, including physicians, pharmacies, hospitals, private companies and distributors in the private sector; and governmental entities and non-governmental organizations in the public and international donor markets, respectively. Animal Health Products are sold and/or distributed by various channels depending on national legislation applicable to veterinary products. Merial markets its products to either veterinarians, pharmacies, or wholesalers. In the event of an epidemic, Merial delivers directly to governments. Strategy The company’s strategy includes improving a global healthcare leader with synergistic platforms; bringing innovative products to market; seizing value-enhancing growth opportunities; and adapting its structure for future opportunities and requirements. Research and Development Pharmaceuticals Diabetes Solutions Lixilan Fixed-Ratio: Lixilan Fixed-Ratio, a combination of insulin glargine and lixisenatide, is under clinical development, a proof-of-concept study to examine the glycemic control of Lixilan versus insulin glargine alone over 24 weeks was completed in 2014. The Lixilan Phase III program is ongoing with two clinical studies. Insulin lispro biosimilar (SAR342434): The program entered Phase III in November 2014. The Phase III clinical program would compare SAR342434 to Humalog (insulin lispro, Eli Lilly and Company) in patients with type 1 Diabetes Mellitus on top of Lantus treatment (SORELLA 1) and in patients with type 2 Diabetes Mellitus (SORELLA 2). Additionally, a new dual glucagon agonist (SAR425899) entered Phase I in July 2014 for the treatment of patients with type 2 Diabetes Mellitus. Oncology Main Products in Phase II SAR650984 is a naked humanized immunoglobulin (IgG1) monoclonal antibody (mAb) that has been in-licensed from Immunogen Inc. It selectively binds to CD38, a cell surface antigen expressed in multiple myeloma cancer cells, and other hematological malignancies. The program is in Phase II with five ongoing or planned studies in multiple myeloma. Two studies are ongoing, one as a single agent and the other one in combination with lenalidomide/dexamethasone. Enrollment of patients into the three planned studies is due to begin in 2015. These studies are investigating SAR650984 in combinations with carfilzomib, pomalidomide, and bortezomib/dexamethasone. SAR245409 (XL765) is in-licensed from Exelixis, Inc. and is being developed by the company. This oral agent is dual inhibitor of both phosphoinositide-3-kinase (PI3K) and the mammalian target of rapamycin (mTOR). A Phase II trial of monotherapy in mantle cell lymphoma, follicular lymphoma, chronic lymphocytic leukemia and diffuse large B cell lymphoma, and a Phase II trial in combination with pimasertib (MEK inhibitor from Merck Serono) in Low Grade Serious Ovarian, are ongoing. Coltuximab ravtansine (SAR3419) is an antibody drug conjugate (ADC) maytansin-loaded anti-CD19 mAb that has been in-licensed from Immunogen Inc and is being developed in Phase II in B-cell malignancies. Main Products in Early Stage SAR125844 is a potent and selective MET-tyrosine-kinase inhibitor. The development of this compound is being conducted by the company using two clinical Phase I single agent studies in Europe, the United States, and the Asia Pacific, with SAR125844 administered intravenously every week. The start of the Phase II program is planned in 2015. SAR245408 (XL147) is in-licensed from Exelixis, Inc. and is being developed by the company.
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