Biogen
Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, United States specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide. Biogen operates in Argentina, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Sweden, and Switzerland.[2]
Formerly
Biogen Idec Inc. (2003–2015)
- Nasdaq: BIIB
- Nasdaq-100 component
- S&P 500 component
1978
Cambridge, Massachusetts, U.S.
- Caroline Dorsa (chairman)
- Chris Viehbacher (CEO)
US$9.836 billion (2023)
US$1.297 billion (2023)
US$1.162 billion (2023)
US$26.84 billion (2023)
US$14.80 billion (2023)
7,570 (2023)
Biogen focused its R&D efforts on the discovery and development of treatments for patients with high unmet medical needs in the areas of neurology, hematology, and immunology.
Investigational MS medicines:
Biogen has several candidates in Phase 1 and 2 clinical trials in neurodegenerative and immunological diseases including MS, neuropathic pain, spinal muscular atrophy and lupus nephritis:
Biogen also has several development agreements in place with Ionis Pharmaceuticals to collaborate to leverage antisense technology in advancing the treatment of neurological disorders.[85]
In February 2012, Biogen formalized a joint venture with Samsung, creating Samsung Bioepis. This joint venture brings Biogen's expertise and capabilities in protein engineering, cell line development, and recombinant biologics manufacturing to position the joint venture so Biogen can participate in the emerging market for biosimilars.[86]
In early 2014, Biogen entered into an agreement with Eisai, Inc., to jointly develop and commercialize two of their candidates for Alzheimer's disease, which have the potential to reduce Aβ plaques that form in the brains of patients, as well as to slow the formation of new plaques, potentially improving symptoms and suppressing disease progression.[87]
Biogen also has since 2015 an agreement with AGTC to develop gene therapy for several genetic diseases, including X-linked retinoschisis (XLRS) and X-linked Retinitis pigmentosa (XLRP) ophthalmologic diseases. To this aim, Biogen paid AGTC $124 million, including an equity investment of $30 million, and up to 1,1 billion in future milestones.[88]
In March 2019, Biogen halted Phase 3 trials of Alzheimer's disease drug Aducanumab after "an independent group's analysis show[ed] that the trials were unlikely to 'meet their primary endpoint.'"[89] However, in October 2019 they reversed their plans and said that they would be pursuing US FDA approval for Aducanumab. The reversal came after Biogen said a new analysis of a larger patient pool showed promising results.[35] In July 2020, Biogen completed submission of a Biologics license application (BLA) to the FDA for review, and requested accelerated review.[90] However, an advisory panel for the FDA voted against approval of this drug.[91] On June 7, 2021, the FDA granted approval of Aducanumab for the treatment of Alzheimer's disease. Aducanumab was approved using the accelerated approval pathway, and Biogen will be required to conduct a post-approval clinical trial to verify clinical benefit for continued approval.[92]