Profile: Biogen Inc (BIIB.O)
27 Nov 2015
Biogen Inc., formerly Biogen Idec Inc., incorporated on April 1, 1997, is a global biopharmaceutical company. The Company is focused on discovering, developing, manufacturing and delivering therapies for neurological, autoimmune and hematologic disorders. The Company's marketed products include AVONEX, PLEGRIDY, TECFIDERA, TYSABRI, FAMPYRA for multiple sclerosis (MS), ALPROLIX for hemophilia B, and ELOCTATE for hemophilia A, among others. It also collaborates on the development and commercialization of RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia and other conditions and for GAZYVA, which is for the treatment of chronic lymphocytic leukemia.
Multiple Sclerosis Products
The Company develops, manufactures and markets a number of products designed to treat patients with MS. Its MS products include AVONEX, PLEGRIDY, TECFIDERA, TYSABRI and FAMPYRA. AVONEX (interferon beta-1a) is an intramuscular injectable therapy, indicated for the treatment of patients with relapsing forms of MS. AVONEX is a recombinant form of the interferon beta protein produced in the body in response to viral infection. The principal markets for AVONEX are the United States, United Kingdom, France, Germany, Italy and Spain. PLEGRIDY (peginterferon beta-1a) is a subcutaneous injectable therapy, indicated in the United States for the treatment of relapsing forms of MS and in the European Union (E.U.) for relapsing-remitting MS (RRMS). TECFIDERA (dimethyl fumarate) is an oral therapy indicated in the United States for the treatment of relapsing forms of MS and in the EU for people with RRMS. TYSABRI (natalizumab) is a monoclonal antibody, which is a monotherapy for the treatment of relapsing forms of MS. TYSABRI is also used to treat Crohn's disease, an inflammatory disease of the intestines. The principal markets for TYSABRI in MS are the United States, the United Kingdom, France, Germany, Italy and Spain. FAMPYRA (prolonged-release fampridine tablets), is indicated for the improvement of walking ability in adult patients with MS. FAMPYRA is a prolonged-release tablet formulation of the drug fampridine. Its principal markets for FAMPRYA are France, Germany, Spain and Canada.
The Company develops, manufactures and markets products designed to treat patients with hemophilia A and B. Its products for hemophilia A and B include ALPROLIX and ELOCTATE. ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is a recombinant deoxyribonucleic acid-derived (DNA-derived), coagulation Factor IX concentrate indicated in the United States for treatment in adults and children with hemophilia B for control and prevention of bleeding episodes, perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ELOCTATE (Antihemophilic Factor (Recombinant), Fc Fusion Protein) is a recombinant DNA-derived, antihemophilic factor indicated in the United States for treatment in adults and children with hemophilia A for control and prevention of bleeding episodes, perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. It collaborates with Swedish Orphan Biovitrum AB (Sobi) to jointly develop and commercialize Factor VIII and Factor IX hemophilia products, including ELOCTATE and ALPROLIX.
The Company collaborates with Genentech, Inc. (Genentech), a wholly owned member of the Roche Group, on the development and commercialization of RITUXAN. The Roche Group and its sub-licensees maintain sole responsibility for the development, manufacturing and commercialization of GAZYVA in the United States. RITUXAN (rituximab) is a monoclonal antibody used to treat non-Hodgkin's lymphoma, rheumatoid arthritis, chronic lymphocytic leukemia (CLL) and two forms of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. GAZYVA (obinutuzumab), in combination with chlorambucil, is indicated for the treatment of patients with previously untreated CLL. FUMADERM (fumaric acid esters) is a prolonged-release tablet formulation for the treatment of adult patients with moderate to severe plaque psoriasis.
The product candidate FUMADERM (fumaric acid esters) is a prolonged-release tablet formulation. FUMADERM is approved in Germany only for the treatment of adult patients with moderate to severe plaque psoriasis.
Late Stage Product Candidates
The Company's late-stage product candidates include programs in Phase III development or in registration stage. Its late-stage products include ZINBRYTA, TYSABRI, ELOCTATE, ALPROLIX, GAZYVA and ISIS-SMN. ZINBRYTA is a monoclonal antibody that is being tested in relapsing-remitting Multiple Sclerosis (RRMS). The Phase III DECIDE clinical trial demonstrated positive top-line results, which investigated ZINBRYTA as a once-monthly, subcutaneous treatment for RRMS. Results showed that ZINBRYTA was superior on the study's primary endpoint, demonstrating a statistically significant reduction in annualized relapse rates when compared to interferon beta-1a (AVONEX). The Company completed patient enrollment in a Phase III study of TYSABRI in secondary progressive Multiple Sclerosis, known as ASCEND. The study involves approximately 875 patients. The Company's product ELOCTATE, a recombinant factor VIII Fc fusion protein (rFVIIIFc), is approved by the Food and Drug Administration (FDA) for the treatment of hemophilia A. The Company has completed a Phase III clinical study that examined the efficacy, safety and pharmacokinetics of rFVIIIFc in males 12 years of age and older with severe hemophilia A and a Phase III clinical study that evaluated the efficacy and safety of rFVIIIFc in children with hemophilia A under the age of 12. The product ALPROLIX was approved by the FDA for the treatment of hemophilia B. The Company is conducting a global pediatric study, Kids B-LONG, evaluating the efficacy and safety of recombinant factor IX Fc fusion protein (rFIXFc) in children with hemophilia B under the age of 12.
The Company is conducting Phase III clinical studies in collaboration with the Roche Group for the development of the product GAZYVA, including GOYA, a study 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, a clinical study 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, and GADOLIN, a study investigating the efficacy and safety of GAZYVA plus bendamustine compared with bendamustine alone in patients with RITUXAN-refractory, indolent non-Hodgkin's lymphoma. The Phase III GADOLIN study demonstrated positive results showing that the study met its primary endpoint early when treated with GAZYVA plus bendamustine followed by GAZYVA alone, compared to bendamustine alone.
The Company is collaboration with Isis Pharmaceuticals, Inc. (Isis), is conducting a pivotal Phase III study evaluating ISIS-SMN in infants with spinal muscular atrophy (SMA). This Phase III study, known as ENDEAR, is a randomized, double-blind, sham-procedure controlled thirteen month study in approximately 110 infants diagnosed with SMA. The study is being conducted to evaluate the efficacy and safety of a 12 milligrams dose of ISIS-SMN with a primary endpoint of survival or permanent ventilation. The Company is also conducting a pivotal Phase III study evaluating the efficacy and safety of ISIS-SMN in non-ambulatory children with SMA. This Phase 3 study, known as CHERISH, is a randomized, double-blind, sham-procedure controlled fifteen month study in approximately 120 children with SMA. The study is being conducted to evaluate the efficacy and safety of a 12 milligram dose of ISIS-SMN 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.
The Company competes with Teva Pharmaceutical Industries Ltd., Merck KGaA, Pfizer Inc. Bayer Group, Novartis AG, Sanofi, GenMab, GlaxoSmithKline, Pharmacyclics and Janssen, Gilead, Johnson & Johnson, AbbVie, Amgen, UCB, S.A., Bristol-Myers Squibb Company, Roche Group, Baxter, Bayer and CSL Behring.
225 Binney St
CAMBRIDGE MA 02142-1031
Company Web Links
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- UPDATE 3-Biogen to cut 11 pct of staff, cancel some drug programs; stock jumps