endamustine alone in patients with RITUXAN-refractory, indolent non-Hodgkin's lymphoma. In February 2015, the Roche Group announced positive results from the Phase 3 GADOLIN study. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint early, showing that people lived significantly longer without disease worsening or death (progression-free survival) when treated with GAZYVA plus bendamustine followed by GAZYVA alone, compared to bendamustine alone. Ocrelizumab In June 2015, the Roche Group announced positive results from two Phase 3 studies evaluating ocrelizumab compared with interferon beta-1a in people with relapsing forms of MS. Treatment with ocrelizumab compared with interferon beta-1a significantly reduced the annualized relapse rate over a two-year period, significantly reduced the progression of clinical disability; and led to a reduction in the number of lesions in the brain as measured by MRI. In September 2015, the Roche Group announced positive results from a Phase 3 study evaluating ocrelizumab in people with PPMS. Treatment with ocrelizumab reduced the progression of clinical disability compared with placebo, as measured by the Expanded Disability Status Scale. Biosimilars (Samsung Bioepis - Biogen's Joint Venture with Samsung Biologics) FLIXABI: Samsung Bioepis' MAA for FLIXABI, an infliximab biosimilars candidate referencing REMICADE, was validated and accepted by the EMA in March 2015. If approved, under the company’s agreement with Samsung Bioepis, the company has commercialization rights to FLIXABI in specified E.U. countries. Marketing and Distribution The company promotes its products worldwide, including in the U.S., most of the major countries of the E.U. and Japan, primarily through the company’s own sales forces and marketing groups. In some countries, particularly in areas where the company continues to expand into new geographic areas, the company partners with third parties. The company focuses its sales and marketing efforts on specialist physicians in private practice or at major medical centers. The company uses customary pharmaceutical company practices to market its products and to educate physicians, such as sales representatives calling on individual physicians, advertisements, professional symposia, direct mail, public relations and other methods. The company distributes its products in the U.S. principally through wholesale distributors of pharmaceutical products, mail order specialty distributors or shipping service providers. In other countries, the distribution of its products varies from country to country, including through wholesale distributors of pharmaceutical products and third-party distribution partners who are responsible for most marketing and distribution activities. RITUXAN and GAZYVA are marketed and distributed by the Roche Group and its sublicensees. The company’s product sales to two wholesale distributors, AmerisourceBergen and McKesson, each accounted for approximately 10% of the company’s total revenues, and on a combined basis, accounted for approximately 60% of its gross product revenues for the year ended December 31, 2015. Business Relationships AbbVie Biotherapeutics, Inc. The company has a collaboration agreement with AbbVie Biotherapeutics, Inc. aimed at advancing the development and commercialization of ZINBRYTA in MS. Acorda Therapeutics, Inc. The company collaborates with Acorda Therapeutics, Inc. to develop and commercialize products containing fampridine, such as FAMPYRA, in markets outside the U.S. The company also has responsibility for regulatory activities and the future clinical development of related products in those markets. Applied Genetic Technologies Corporation (AGTC) In 2015, the company entered into a collaboration agreement with AGTC to develop gene-based therapies for multiple ophthalmic diseases. The collaboration focuses on the development of a clinical-stage candidate for X-linked Retinoschisis and a preclinical candidate for the treatment of X-linked Retinitis Pigmentosa, for which the company was granted wor
biogen inc (IDP:German Stock Exchange)
225 Binney Street
Cambridge, MA 02142
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