would receive tiered royalty payments on sales of ocrelizumab. Biosimilars (Samsung Bioepis – the company’s Joint Venture with Samsung BioLogics Co. Ltd. (Samsung Biologics)) BENEPALI: In November 2015, Samsung Bioepis received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the MAA for BENEPALI, an etanercept biosimilar referencing ENBREL. In January 2016, the EC approved the MAA for BENEPALI for marketing in the E.U. Under the company’s agreement with Samsung Bioepis, the company would manufacture and commercialize BENEPALI in specified E.U. countries. FLIXABI: In March 2015, the EMA validated and accepted Samsung Bioepis’ MAA for FLIXABI, an infliximab biosimilar candidate referencing REMICADE. Late Stage Product Candidates MS ZINBRYTA (daclizumab high yield process): ZINBRYTA is a monoclonal antibody for the treatment of relapsing-remitting MS (RRMS). In 2014, the company announced positive results from the Phase 3 DECIDE clinical trial, which investigated ZINBRYTA as a potential once-monthly, subcutaneous treatment for RRMS. The company’s MAA for ZINBRYTA was validated by the EMA in March 2015, and the BLA was accepted by the FDA in April 2015. Hemophilia ALPROLIX (Coagulation Factor IX (Recombinant), Fc Fusion Protein): In March 2014, ALPROLIX was approved by the FDA for the treatment of hemophilia B. Pediatric data was required as part of the MAA for ALPROLIX that the company submitted to the EMA. In February 2015, the company and Sobi announced positive results of the Kids B-LONG Phase 3 clinical study that evaluated the safety, efficacy and pharmacokinetics of ALPROLIX in children under age 12 with severe hemophilia B. Following these results, the company filed a MAA in the E.U., which was validated by the EMA in June 2015. Neurodegeneration Aducanumab (BIIB037): In September 2015, the company enrolled its first patient in its two global Phase 3 studies, ENGAGE and EMERGE. ENGAGE and EMERGE would assess the efficacy and safety of aducanumab in approximately 2,700 people with early Alzheimer's disease. The studies are identical in design and eligibility criteria. Each study would be conducted in approximately 20 countries in North America, Europe, and Asia. In October 2015, the company announced that it received FDA agreement on a special protocol assessment on the Phase 3 study protocols. Other Programs Nusinersen (IONIS-SMNRx): In 2014, Ionis announced the initiation of a pivotal Phase 3 study evaluating nusinersen in infants with SMA, the most common genetic cause of infant mortality. This Phase 3 study, known as ENDEAR, is a randomized, double-blind, sham-procedure controlled 13 month study in approximately 110 infants diagnosed with SMA. The study is evaluating the efficacy and safety of a 12mg dose of nusinersen with a primary endpoint of survival or permanent ventilation. In November 2014, Ionis announced the initiation of a pivotal Phase 3 study evaluating the efficacy and safety of nusinersen in non-ambulatory children with SMA. This Phase 3 study, known as CHERISH, is a randomized, double-blind, sham-procedure controlled 15 month study in approximately 120 children with SMA. The study is evaluating the efficacy and safety of a 12mg dose of nusinersen with a primary endpoint of a change in the Hammersmith Functional Motor Scale-Expanded, a validated method to measure changes in muscle function in patients with SMA. Genentech Relationships GAZYVA (obinutuzumab) The Roche Group is managing the following Phase 3 studies of GAZYVA: GOYA: Investigating the efficacy and safety of GAZYVA in combination with CHOP chemotherapy compared to RITUXAN with CHOP chemotherapy in previously untreated patients with CD20-positive diffuse large B-cell lymphoma. GALLIUM: Investigating the efficacy and safety of GAZYVA in combination with chemotherapy followed by maintenance with GAZYVA compared to RITUXAN in combination with chemotherapy followed by maintenance with RITUXAN in previously untreated patients with indolent non-Hodgkin's lymphoma. GADOLIN: Investigating the efficacy and safety of GAZYVA plus bendamustine compared with b
(BIIB:Consolidated Issue Listed on NASDAQ Global Select )
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