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Biogen

Coordinates:42°21′58.3″N71°5′13.2″W / 42.366194°N 71.087000°W /42.366194; -71.087000
From Wikipedia, the free encyclopedia
American pharmaceutical company
Biogen Inc.
FormerlyBiogen Idec Inc. (2003–2015)
Company typePublic
IndustryBiotechnology
Founded1978; 48 years ago (1978)
Founders
HeadquartersCambridge, Massachusetts, U.S.
Key people
Products
RevenueDecreaseUS$9.676 billion (2024)
Increase US$1.906 billion (2024)
Increase US$1.632 billion (2024)
Total assetsIncrease US$28.05 billion (2024)
Total equityIncrease US$16.72 billion (2024)
Number of employees
7,605 (2024)
Websitebiogen.com
Footnotes / references
[1]

Biogen Inc. is an Americanmultinationalbiotechnology company based inCambridge, Massachusetts,United States specializing in the treatment ofneurological diseases.[1] The company's primary products aredimethyl fumarate (Tecfidera),diroximel fumarate (Vumerity),interferon beta-1a (AVONEX),peginterferon beta-1a (Plegridy), andnatalizumab (Tysabri), all for the treatment ofmultiple sclerosis (collectively 45% of 2024 revenues);nusinersen (Spinraza) for the treatment ofspinal muscular atrophy (16.2% of 2024 revenues);omaveloxolone (Skyclarys) for the treatment ofFriedreich's ataxia (4.0% of 2024 revenues);tofersen (Qalsody) for the treatment ofALS; anddimethyl fumarate (Fumaderm) for the treatment of severeplaque psoriasis.[1] The company also produces 5 biosimilars (8.2% of 2024 revenues) and has collaborations withGenentech for several drugs (18.1% of 2024 revenues).[1]

The company is ranked 424th on theFortune 500[2] and 845th on theForbes Global 2000.[3]

History

[edit]

Biogen was founded in 1978 inGeneva asBiotechnology Geneva by several prominent biologists, includingKenneth Murray from theUniversity of Edinburgh,Phillip Allen Sharp from theMassachusetts Institute of Technology,Walter Gilbert fromHarvard University (Gilbert served as CEO during the start-up phase of Biogen), Heinz Schaller from theUniversity of Heidelberg, andCharles Weissmann from theUniversity of Zurich (Weissmann contributed the first productinterferon alpha).[4][5][6] Gilbert and Sharp were subsequently honored withNobel Prizes: Gilbert was recognized in 1980 with theNobel Prize in Chemistry for his understanding ofDNA sequencing[7] and Sharp received theNobel Prize in Physiology or Medicine in 1993 for his discovery ofsplit genes.[8]

In 2003, Biogen merged withSan Diego, California-based IDEC Pharmaceuticals (formed in 1985 byUniversity of California-San Diego's physicians and immunologistsIvor Royston and Robert E. Sobol, San Diego bio entrepreneurHoward Birndorf, and Stanford University cancer researchers Ron Levy and Richard Miller) and adopted the name Biogen Idec.[9][10] After the merger, Biogen Idec became the 3rd largest Biotechnology company in the world.[11]

Following shifts in research core areas, the company has since shortened its name, reverting to simply Biogen.[12]

In May 2006, the company announced it would acquire cancer specialist, Conforma Therapeutics for $250 million.[13] Later in the same month, the company announced its intention to acquire Fumapharm AG, consolidating ownership ofFumaderm andBG-12, an oralfumarate, which was being studied for the treatment ofmultiple sclerosis andpsoriasis.[14]

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.[15][16][17]

In 2008, two new brain infection cases fromTysabri users surfaced inEurope that raised international concern about Tysabri and its effects with the progressive multifocalleukoencephalopathy (PML) brain condition. Biogen is one of the drug's producers.[18]

In 2011, Biogen announced that its drug Fampyra received conditionalmarketing approval. Under the conditional approval, Biogen agrees to provide additional data on the long-term benefits and safety of Fampyra.[19]

On December 10, 2012, Biogen announced its global collaboration agreement withIsis Pharmaceuticals to develop and researchantisense drugs to treatneurological andneuromuscular diseases.[20]

In February 2013,Bloomberg broke the news that Biogen was planning to payElan $3.25 billion for the full rights toTysabri, used to treat multiple sclerosis.[21]

In 2013, Biogen was the first U.S.-based biotechnology company to appear on theDow Jones Sustainability World Index.[22]

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 particularCNV1014802 – a Phase II small molecule sodium channel blocking candidate.[23] In October 2015, the company announced that it would lay off 11% of its workforce, effective immediately.[24]

On May 3, 2016, Biogen announced plans to spin off its hemophilia business, known asBioverativ as an independent publicly traded company. Bioverativ offered two hemophilia drugs in 2016, Alprolix and Eloctate, and plans on developing its Hemophilia-focused goals.[25]

In 2016, Biogen released Spinraza (nusinersin), a treatment for Spinal Muscular Atrophy. The drug is among the most expensive treatments available, with a price of $750,000 for the first year of doses, and $375,000 for each subsequent year and likely for the rest of a patient's life.[26] While there still isn't a cure, Spinraza significantly improves the quality of life in infants and adults.

In 2017, Biogen announced that its drug Fampyra converted from conditional marketing authorization to standard marketing approval.EUmultiple sclerosis (MS) patients use Fampyra to improve walking.[19]

In February 2020, Biogen andSangamo Therapeutics announced a global licensing deal to develop compounds for neuromuscular and neurological diseases.[27]

In September 2020, Biogen Inc. made a $10 million deposit inOneUnited Bank to provide more capital to fund home loans and commercial development in Black communities.[28] In November, the company announced it would acquire a $650 million stake in Cambridge-based Sage Therapeutics and make an upfront payment of $875 million, in order to jointly develop depression treatments.[29]

In July 2023, Biogen acquiredReata Pharmaceuticals, headquartered inPlano, Texas, for nearly $6.5 billion.[30] That month, the company also cut 1,000 jobs, or 11% of its workforce.[31]

In May 2024, Biogen acquired Human Immunology Biosciences (HI-Bio) for $1.15 billion.[32]

In July 2025, the company announced a $2 billion investment in manufacturing facilities inResearch Triangle Park.[33][34]

In September 2025, the company agreed to acquire Alcyone Therapeutics for $85 million.[35][36] In November 2025, it was announced the acquisition had been completed.[37]

Aducanumab

[edit]
Main article:Aducanumab

In 2007, the company reached a licensing agreement with Neurimmune, a spin-off from the University of Zurich, for theAlzheimer's disease drug,Aducanumab, developed by thisSwiss company. Later, Neurimmune sold its rights for license fees for $200 million to Biogen.[5]

In December 2014, Biogen announced that Aducanumab for Alzheimer's treatment was preparing to go through a late-stage trial of its experimental Alzheimer's disease treatment after the medication dramatically improved cognition and reduced brain plaque levels in early-stage study.[38]

In March 2015, Aducanumab became the first experimental Alzheimer's treatment to show significant results in regard to slowing down cognitive decline and reducing brain-destroying plaques.[39] In July 2015, Biogen initiated two late-stage studies called ENGAGE and EMERGE, which will assess Aducanumab in adults with early Alzheimer's disease.[40]

In 2016, Aducanumab decreased amoyloid-beta in the brains of people with early-stage Alzheimer's disease, according to a report published in Nature on August 31, 2016.[41] On March 21, 2019, Biogen announced that the Phase 3 clinical trials of Aducanumab were halted.[42] Biogen announced it would acquire Nightstar Therapeutics for $25.50 per share ($800 million in total). Nightstar focused on adeno-associated virus based gene-therapies for inherited retinal disorders.[43][44] With a setback in their drug research, Biogen's shares fell sharply that same month.[45] It ended the trial of Aducanumab, which it was making along withEisai.[46] In October 2019, however, they announced that they would pursue FDA approval together with Eisai.[47]

On October 22, 2019, despite two Phase 3 clinical trials being previously halted for futility, Biogen announced its plan to submit for FDA's approval of Aducanumab.[48] In May 2020, Biogen wrapped up construction on a state-of-the-art facility inSolothurn,Switzerland, which will produce Aducanumab by late 2021, alongside itsNorth Carolina manufacturing facility. Themonoclonal antibody, co-developed withEisai, attracted considerable interest from biotech investors whenWarren Buffett'sBerkshire Hathaway bought 648,447 Biogen shares at a combined value of $192.4 million.[49]

On July 8, 2020, Biogen andEisai announced that both companies had together successfully submitted for Aducanumab's FDA regulatory and marketing approval.[50]

On June 7, 2021, theFDA gave accelerated approval to Aducanumab under the name Aduhelm,[51] which proved to be controversial.[52][53] The drug was priced at $56,000 US dollars per year, but it was not covered by many insurers as they awaited further proof that the drug was effective.[54] The US Government did not subsidise it outside clinical trials.[55] According to the FDA's website, the drug was proven to reduce amyloid-beta plaques in the brain, which was likely to benefit patients. The FDA has stated that if the post-approval trial did not indicate that Aduhelm works, the drug may be taken out of the market.[56]

Biogen abandoned the drug in January 2024, for financial reasons.[57]

Bioverativ

[edit]

In January 2017, the company completed thecorporate spin-off its hemophilia drug business (Eloctate andAlprolix) into a public company, later namedBioverativ. It was acquired bySanofi in 2018 for $11.6 billion.[58][59][60][61][62][63][64]

Acquisition history

[edit]

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):

  • Biogen
    • Biogen IDEC
      • Biogen(Est 1978)
      • IDEC Pharmaceuticals
    • Conforma Therapeutics(Acq 2006)
    • Fumapharm AG(Acq 2006)
    • Syntonix Pharmaceuticals(Acq 2007)
    • Convergence Pharmaceuticals(Acq 2015)
    • Nightstar Therapeutics(Acq 2019)
    • Reata Pharmaceuticals(Acq 2023)
    • Human Immunology Biosciences (HI-Bio)[32]

Conference during COVID-19 pandemic that led to 300,000 cases

[edit]
See also:COVID-19 pandemic

On March 5, 2020, Biogen reported that three individuals who met with their employees at a conference inBoston had tested positive forCOVID-19 the previous week.[65] On March 6, public health officials reported five new cases associated with the Biogen leadership meeting[66][67] and by March 9, Massachusetts health officials had announced 30 new presumptive COVID-19 cases, all connected to the Biogen conference.[68][69] Researchers first estimated that the conference would be linked to over 20,000 of the state'sCOVID-19 cases.[70][71] Researchers later estimated that up to 300,000 cases worldwide had been caused by the Biogen conference, including 1.6% of all U.S. cases ofCOVID-19.[71]

Finances

[edit]
YearRevenue
in mil. USD$		Net income
in mil. USD$		Total Assets
in mil. USD$		Price per Share
in USD$		Employees
20052,4231618,38239.89
20062,6832188,55342.39
20073,1726388,62952.16
20084,0987838,47951.09
20094,3779708,55245.11
20104,7161,0058,09251.95
20115,0491,2349,05084.78
20125,5161,38010,130125.83
20136,9321,86211,863198.436,850
20149,7032,93514,315293.107,550
201510,7643,54719,505324.997,350
201611,4493,70322,877258.277,400
201712,2742,53923,653289.197,300
2018[72]13,4534,43125,2897,800
2019[73]14,3785,88927,2347,400
2020[74]13,4454,00124,6199,100
2021[75]10,9811,55623,877
2022[75]10,1733,04624,554
2023[75]9,8351,16126,844

Products

[edit]
TherapyIndication (In United States unless otherwise noted)Year Approved (US)Year Approved (EU)Additional information
LEQEMBI™ [(lecanemab-irmb)]Indicated for patients with mild cognitive impairment or mild dementia stages of Alzheimer's disease.2023(pending)Biogen and JapaneseEisai are collaborators in the development and commercialization of LEQEMBI.[76]
ADUHELM™ [(aducanumab) Human Immunoglobulin Gamma 1 (IgG1)monoclonal antibody]Indicated for all stages of Alzheimer's disease, including patients with confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia.2021(pending)U.S. FDA accelerated approval.

Biogen and JapaneseEisai are collaborators in the development and commercialization of ADUHELM.[77]

ALPROLIX™ [CoagulationFactor IX (Recombinant), Fc Fusion Protein]Control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children withhemophilia B20211993Also approved in Canada and Australia.

Biogen and Swedish Orphan Biovitrum (Sobi) are collaborators in the development and commercialization of ALPROLIX.[78]

AVONEX® (interferon beta-1a)Relapsing forms ofmultiple sclerosis19961997Includes the AVONEX PEN auto-injector and the AVOSTARTGRIP titration kit approved in the U.S. in 2012.[79]
ELOCTATE™ [Antihemophilic Factor (Recombinant), Fc Fusion Protein]Control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children withhemophilia A20141999Biogen and Swedish Orphan Biovitrum (Sobi) are collaborators in the development and commercialization of ELOCTATE.[80]
FAMPYRA (prolonged-releasefampridine tablets)Multiple sclerosis (Walking ability)20102011Marketed by Biogen in markets outside of the United States.

Commercialized in the United States as AMPYRA (dalfampridine) Extended Release Tablets, byAcorda Therapeutics.[81]

FUMADERM (fumaric acid esters)Psoriasis German use1994 (Germany only)Approved in Germany.

Acquired in acquisition of Fumapharm AG in 2006.[82]

GAZYVA (obinutuzumab)Chronic lymphocytic leukemia20132014The first medicine approved with the FDA's Breakthrough Therapy Designation and is also currently in Phase 3 trials for NHL and diffuse large B-cell lymphoma.

Currently commercialized in the United States by Genentech, a wholly owned subsidiary of Roche.[83]

IMRALDI (adalimumab)Immunosuppressive drug to treat autoimmune disorders such asinflammatory bowel disease20192018Biosimilar ofAbbVie's Humira.[84][85]
SPINRAZA (nusinersen)Spinal muscular atrophy (SMA)20162017The first drug approved for the treatment ofspinal muscular atrophy, developed in collaboration withIonis Pharmaceuticals.[86][87]
PLEGRIDY (peginterferon beta-1a)Relapsing forms of multiple sclerosis2014[88]2014[89]
RITUXAN (rituximab)Non-Hodgkin lymphoma (NHL)

Anti-TNF Refractory Rheumatoid Arthritis

ANCA-Associated Vasculitis

Chronic lymphocytic leukemia

1997[90]

2006[91]

2011[92]

1998 (as MabThera)The first monoclonal antibody for cancer developed by IDEC, prior to merging with Biogen.

Currently commercialized by Roche and its subsidiary, Genentech.

TECFIDERA (dimethyl fumarate)Relapsing forms ofmultiple sclerosis2013[93]2014[94]
TYSABRI (natalizumab)Relapsing-remittingmultiple sclerosis2004 Re-introduced in 20062006Full rights purchased from partner Elan in 2013.[95]

Pipeline

[edit]

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 withAbbvie, 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.[96]
  • Anti-LINGO-1 (BIIB033) (Opicinumab): is the first candidate being investigated for its potential to remyelinate and repair neurons damaged by MS. Phase II trials were conducted in 2016 but failed to reach their goals.[97]

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-SOD1Rx) foramyotrophic 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.[98]

In February 2012, Biogen formed a joint venture withSamsung, Samsung Bioepis. Samsung acquired Biogen's interest in the venture in January 2022 for up to $2.3 billion.[99]

In early 2014, Biogen entered into an agreement with Eisai 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.[98]

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. Biogen paid AGTC $124 million, including an equity investment of $30 million, and offered up to $1.1 billion in future milestone payments.[100]

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.'"[101] 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.[47] In July 2020, Biogen completed submission of aBiologics license application (BLA) to the FDA for review, and requested accelerated review.[102] However, an advisory panel for the FDA voted against approval of this drug.[103] 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.[104]

Lawsuits

[edit]

In September 2022, Biogen agreed to pay $900 million to the U.S. federal government, states, and a whistleblower. Biogen hadbribed doctors between 2009 and 2014 to increase prescriptions ofAvonex,Tysabri, andTecfidera (all formultiple sclerosis).[105]

See also

[edit]

References

[edit]
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