Biogen Inc., a biopharmaceutical company, focuses on discovering, developing, manufacturing and delivering therapies to patients for the treatment of neurodegenerative diseases, hematologic conditions, and autoimmune disorders. The company’s marketed products include TECFIDERA, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for multiple sclerosis (MS); ELOCTATE for hemophilia A and ALPROLIX for hemophilia B; and FUMADERM for the treatment of severe plaque psoriasis. The company also has a collaboration agreement with Genentech, Inc. (Genentech), a wholly-owned member of the Roche Group (Roche Group), which entitles the company to certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL) and other conditions, GAZYVA indicated for the treatment of CLL, and other anti-CD20 therapies. Product/Pipeline Developments MS ZINBRYTA (daclizumab high yield process) In March 2015, the European Medicines Agency (EMA) validated the company’s marketing authorization application (MAA) for ZINBRYTA for the treatment of relapsing forms of MS in the European Union (E.U.). In April 2015, the United States (U.S.) Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) for ZINBRYTA for the treatment of relapsing forms of MS in the U.S. TYSABRI (natalizumab) In July 2015, the results of ACTION, the company’s Phase 2 trial investigating TYSABRI in acute ischemic stroke, did not demonstrate an impact on change in infarct volume, the primary endpoint. Exploratory endpoints suggested that TYSABRI had a beneficial impact on patient functional deficits. Anti-LINGO In January 2015, the company announced results from RENEW, the company’s Phase 2 acute optic neuritis trial. Hemophilia ELOCTATE (Antihemophilic Factor (Recombinant), Fc Fusion Protein) In November 2015, the European Commission (EC) approved ELOCTA, the approved trade name for ELOCTATE in the E.U., for the treatment of hemophilia A. Swedish Orphan Biovitrum AB (publ) (Sobi) has assumed final development and commercialization of ELOCTA in their territory, which includes Europe, North Africa, Russia, and certain markets in the Middle East (Sobi Territory). ALPROLIX (Coagulation Factor IX (Recombinant), Fc Fusion Protein) In June 2015, the EMA validated the company’s MAA for ALPROLIX for the treatment of hemophilia B. In July 2015, Sobi exercised its option to assume final development and commercialization of ALPROLIX in the Sobi Territory. Neurodegeneration Aducanumab (BIIB037) In March 2015 and July 2015, the company announced data from pre-specified interim analyses of PRIME, the company’s Phase 1b study of aducanumab. In September 2015, the company enrolled its first patient in the company’s two global Phase 3 studies, ENGAGE and EMERGE, to assess the efficacy and safety of aducanumab in people with early Alzheimer's disease. In October 2015, the company announced that it received FDA agreement on a special protocol assessment on the Phase 3 study protocols. Such agreement constitutes FDA’s concurrence on the design and size of the clinical trials, which would form the basis for approval of aducanumab. Other Programs Nusinersen (ISIS-SMNRx) In June 2015, the company’s collaborator, Ionis Pharmaceuticals, Inc. (Ionis), announced additional data from two Phase 2 studies of nusinersen for the treatment of spinal muscular atrophy (SMA) in infants and children. There are two ongoing Phase 3 studies of nusinersen. Genentech Relationships GAZYVA (obinutuzumab): In February 2015, the Roche Group announced positive results from its Phase 3 GADOLIN study of GAZYVA in non-Hodgkin’s lymphoma. 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. In September 2015, the Roche Group announced positive results from a Phase 3 study evaluating ocrelizumab in people with primary progressive MS (PPMS). Under the company’s agreement with Genentech, if ocrelizumab is approved, the company
biogen inc (BIIB*:Mexico)
225 Binney Street
Cambridge, MA 02142
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