Biogen

Biogen was founded in 1978 in Geneva[3] by several prominent biologists, including Kenneth Murray of the University of Edinburgh, Phillip Allen Sharp of the Massachusetts Institute of Technology, Walter Gilbert of Harvard (who served as CEO during the start-up phase), Heinz Schaller, University of Heidelberg and Charles Weissmann, University of Zurich (who contributed the first product interferon alpha). Gilbert and Sharp were subsequently honored with Nobel Prizes: Gilbert was recognized in 1980 with the Nobel Prize in Chemistry for his work in understanding DNA sequencing, while Sharp received the Nobel Prize in Physiology or Medicine in 1993 for his discovery of split genes.

In 2003, Biogen merged with San Diego, California-based IDEC Pharmaceuticals (formed in 1985 by University of California-San Diego physicians and immunologists Ivor Royston and Robert E. Sobol, San Diego bioentrepreneur Howard Birndorf and Stanford University cancer researchers Ron Levy and Richard Miller[4]) and adopted the name Biogen Idec.[5] After the merger, Biogen Idec became the 3rd largest Biotechnology company in the world.[6]

Following shifts in research core areas, the company has since shortened its name, reverting to simply Biogen.[7] Biogen stock is a component of several stock indices such as the S&P 100, S&P 500, S&P 1500, and NASDAQ-100 and the company is listed on the NASDAQ stock exchange under the ticker symbol, BIIB.[8]

In May 2006, the company announced it would acquire cancer specialist, Conforma Therapeutics for $250 million.[9] Later in the same month, the company announced its intention to acquire Fumapharm AG, consolidating ownership of Fumaderm and BG-12, an oral fumarate, which is being studied for the treatment of multiple sclerosis and psoriasis.[10]

In January 2007, the company announced it would acquire Syntonix Pharmaceuticals for up to $120 million, gaining Syntonix's lead product for hemophilia B as well as the technology for developing inhalable treatments.[11][12]

In February 2013, Bloomberg broke the news that Biogen was planning to pay Elan $3.25 billion for the full rights to Tysabri, used to treat multiple sclerosis.[13]

In January 2015, the company announced that it would acquire Convergence Pharmaceuticals for up to $675 million, with the acquisition aiming to accelerate the development of Convergence's pipeline, in particular CNV1014802 – a Phase II small molecule sodium channel blocking candidate.[14] In October 2015, the company announced that it would lay off 11% of its workforce, effective immediately.[15]

In March 2019, Biogen announced it would acquire Nightstar Therapeutics for $25.50 per share ($800 million in total). Nightstar focus on adeno-associated virus based gene-therapies for inherited retinal disorders.[16][17] With a setback in their Alzheimer's drug research, in March 2019 Biogen's shares fell sharply.[18] It ended the trial of its drug aducanumab, which it was making along with Eisai.[19] In October 2019, however, they announced that they would pursue FDA approval for aducanumab together with Eisai.[20]

In February 2020, Biogen and Sangamo Therapeutics announced a global licensing deal to develop compounds for neuromuscular and neurological diseases.[21]

In September 2020, Biogen Inc. made a $10 million deposit in OneUnited Bank to provide more capital to fund home loans and commercial development in Black communities.[22] In November, the company announced it would acquire a $650 million stake in Sage Therapeutics and make an upfront payment of $875 million, in order to jointly develop a number of depression treatments.[23]

For the fiscal year 2017, Biogen reported earnings of US$2.539 billion, with an annual revenue of US$12.274 billion, an increase of 7.2% over the previous fiscal cycle. Biogen's shares traded at over $289 per share, and its market capitalization was valued at over US$63 billion in November 2018.[37] The company ranked 245 on the 2018 Fortune 500 list of the largest United States corporations by revenue.[38]

Biogen has 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:

• Daclizumab High-Yield Process (DAC HYP): is being developed as a potential once-monthly subcutaneous injection in the treatment of relapsing-remitting multiple sclerosis (RRMS). DAC HYP is being developed in collaboration with Abbvie, Inc. In June 2014, the companies announced positive top-line results from the Phase III DECIDE clinical trial, where DAC HYP demonstrated superiority over interferon beta-1a in annualized relapse rate.[55]
• Anti-LINGO-1 (BIIB033) (Opicinumab): is the first candidate being investigated for its potential to remyelinate and repair neurons damaged by MS, currently in Phase 2 trials.[56]

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:

• Phase 2a: anti-LINGO-1 molecule (Opicinumab) in acute optic neuritis
• Phase 2b: anti-TWEAK monoclonal antibody in lupus nephritis
• Phase 2a: STX-100 in patients with idiopathic pulmonary fibrosis
• Phase 2: Neublastin for neuropathic pain in 2013
• Phase 1/2: BIIB067 (ISIS-SOD1_Rx) for amyotrophic lateral sclerosis, in collaboration with Ionis

Biogen also has several development agreements in place with Ionis Pharmaceuticals to collaborate to leverage antisense technology in advancing the treatment of neurological disorders.[57]

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.[58]

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.[59]

Biogen also has since 2015 an agreement with AGTC for the development of gene therapy for ophthalmologic diseases such as X-linked retinoschisis (XLRS) and X-linked Retinitis pigmentosa (XLRP), and up to three other genetic 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.[60]

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.'"[61] 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.[20] In July 2020, Biogen completed submission of a Biologics license application (BLA) to the FDA for review, and requested accelerated review.[62] However, an advisory panel for the FDA voted against approval of this drug.[63]

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