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{{Short description|American pharmaceutical company}} {{Infobox company | name = Biogen Inc. | logo = Biogen.svg | logo_size = 250px | image = Biogen.jpg | image_size = 240px | image_caption = Headquarters in [[Cambridge, Massachusetts]] | former_name = Biogen Idec Inc. (2003–2015) | type = [[Public company|Public]] | traded_as = {{unbulleted list | {{NASDAQ|BIIB}} | [[Nasdaq-100]] component | [[S&P 500]] component }} | founded = {{Start date and age|1978}} | founders = {{ubl|[[Kenneth Murray (biologist)|Kenneth Murray]]|[[Phillip Allen Sharp]]|[[Walter Gilbert]]|Heinz Schaller|[[Charles Weissmann]]}} | key_people = {{ubl|Caroline Dorsa ([[chairman]])|[[Chris Viehbacher]] ([[Chief executive officer|CEO]])}} | industry = [[Biotechnology]] | products = {{hlist|[[Interferon beta-1a#Avonex|Avonex]]| [[4-Aminopyridine|Fampyra]]| [[Interferon beta-1a#Plegridy|Plegridy]]| [[Dimethyl fumarate|Tecfidera]]| [[Natalizumab|Tysabri]]| [[Nusinersen|Spinraza]]}} | revenue = {{decrease}} {{US$|9.676 billion|link=yes}} (2024) | operating_income = {{increase}} US$1.906 billion (2024) | net_income = {{increase}} US$1.632 billion (2024) | assets = {{increase}} US$28.05 billion (2024) | equity = {{increase}} US$16.72 billion (2024) | num_employees = 7,605 (2024) | hq_location = {{nowrap|[[Cambridge, Massachusetts]], U.S.}} | website = {{url|biogen.com}} | footnotes = <ref name=AnnualR2024>{{cite web|title=Biogen, Inc. 2024 Annual Report |url=https://www.sec.gov/ix?doc=/Archives/edgar/data/875045/000087504525000009/biib-20241231.htm |publisher=[[U.S. Securities and Exchange Commission]] |date=February 12, 2025}}</ref> }} '''Biogen Inc.''' is an American [[multinational corporation|multinational]] [[biotechnology]] company based in [[Cambridge, Massachusetts]], [[United States]] specializing in the discovery, development, and delivery of 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.<ref>{{cite web |title=Biogen Inc |url=https://www.bloomberg.com/profile/company/BIIB*:MM#xj4y7vzkg |website=Bloomberg}}</ref> == History == Biogen was founded in 1978 in [[Geneva]] as ''Biotechnology Geneva'' by several prominent biologists, including [[Kenneth Murray (biologist)|Kenneth Murray]] from the [[University of Edinburgh]], [[Phillip Allen Sharp]] from the [[Massachusetts Institute of Technology]], [[Walter Gilbert]] from [[Harvard|Harvard University]] (Gilbert served as CEO during the start-up phase of Biogen), Heinz Schaller from the [[University of Heidelberg]], and [[Charles Weissmann]] from the [[University of Zurich]] (Weissmann contributed the first product [[interferon alpha]]).<ref name="NZZ">Werner Grundlehner: [https://www.nzz.ch/wirtschaft/us-behoerde-gibt-gruenes-licht-fuer-zuercher-antikoerper-mit-milliardenpotenzial-ld.1629215 ''Zürcher Antikörper gegen Alzheimer hat Milliardenpotenzial – und Gegenwind.''] Neue Zürcher Zeitung, June 8, 2021. Retrieved June 8, 2021.</ref><ref>{{cite web|title=Biotech's Comeback Kid|url=https://www.forbes.com/sites/matthewherper/2012/12/04/biogen-idec-biotechs-comeback-kid/|access-date=2012-12-04|work=Forbes}}</ref> Gilbert and Sharp were subsequently honored with [[Nobel Prize]]s: Gilbert was recognized in 1980 with the [[Nobel Prize in Chemistry]] for his understanding of [[DNA sequencing]]<ref name=nobelgilbert>{{cite web|url=https://www.nobelprize.org/prizes/chemistry/1980/gilbert/facts/|title=Walter Gilbert|website=[[Nobel Prize]]|access-date=June 3, 2024}}</ref> and Sharp received the [[Nobel Prize in Physiology or Medicine]] in 1993 for his discovery of [[split gene]]s.<ref name=nobelsharp>{{cite web|url=https://www.nobelprize.org/prizes/medicine/1993/sharp/facts/|title=Phillip A. Sharp|website=[[Nobel Prize]]|access-date=June 3, 2024}}</ref> In 2003, Biogen merged with [[San Diego, California]]-based IDEC Pharmaceuticals (formed in 1985 by [[University of California, San Diego|University of California-San Diego]]'s physicians and immunologists [[Ivor Royston]] and Robert E. Sobol, San Diego bio entrepreneur [[Howard Birndorf]], and Stanford University cancer researchers Ron Levy and Richard Miller) and adopted the name Biogen Idec.<ref>{{Cite web|title=The San Diego Technology Archive|url=https://libraries.ucsd.edu/sdta/companies/idec.html}}</ref><ref name="Exhibit">{{cite web |title=Biogen and IDEC Pharmaceuticals Announce Merger To Create a New Biotechnology Industry Leader |url=https://www.sec.gov/Archives/edgar/data/875045/000104746903021993/a2113458zex-99_1.htm|quote=IDEC — Founded in 1985 to develop monoclonal antibodies. Founders include Ivor Royston, Howard Birndorf, Richard Miller and Brook Byers |website=Exhibit 99.1 |access-date=1 December 2018}}</ref> After the merger, Biogen Idec became the 3rd largest Biotechnology company in the world.<ref>{{cite news|url = https://www.nytimes.com/2003/06/24/business/idec-to-merge-with-biogen-in-6.8-billion-deal.html|title = Idec to Merge With Biogen in $6.8 Billion Deal|work = New York Times |date = 24 June 2003|access-date=2003-06-24|last1 = Pollack|first1 = Andrew}}</ref> Following shifts in research core areas, the company has since shortened its name, reverting to simply Biogen.<ref>{{cite news|url = https://www.wsj.com/articles/biogen-drops-idec-from-name-1427113639|title = Biogen Drops Idec From Name|newspaper = Wall Street Journal|date = 23 March 2015|access-date=2015-03-23|last1 = Dulaney|first1 = Chelsey}}</ref> Biogen stock is a component of several stock indices such as the [[S&P 500]], [[S&P 1500]], and [[NASDAQ-100]] and the company is listed on the [[NASDAQ]] stock exchange under the ticker symbol, BIIB.<ref>{{cite web|url = http://www.nasdaq.com/symbol/biib|title = Biogen Idec Inc. Stock Quote & Summary Data|publisher = NASDAQ}}</ref> In May 2006, the company announced it would acquire cancer specialist, Conforma Therapeutics for $250 million.<ref>{{Cite web|date=2006-06-01|title=Biogen Idec agrees to buy Swiss company Fumapharm|url=http://www.pharmatimes.com/news/biogen_idec_agrees_to_buy_swiss_company_fumapharm_996746|access-date=2017-12-28|website=Pharma Times|language=en}}</ref> 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 was being studied for the treatment of [[multiple sclerosis]] and [[psoriasis]].<ref>{{Cite web|title=Biogen Idec to Acquire Fumapharm AG; Consolidates Ownership of Oral Compound BG-12 Being Studied for Multiple Sclerosis|url=http://www.businesswire.com/news/home/20060531005276/en/Biogen-Idec-Acquire-Fumapharm-AG-Consolidates-Ownership|access-date=2017-12-28|website=Businesswire|language=en}}</ref> 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.<ref>{{Cite web|title=Biogen to buy Syntonix in $120M deal {{!}} FierceBiotech|url=http://www.fiercebiotech.com/biotech/biogen-to-buy-syntonix-120m-deal|access-date=2017-12-28|website=Fierce Biotech|date=3 January 2007 |language=en}}</ref><ref>{{Cite web|title=Biogen Idec to Acquire Syntonix|url=http://www.businesswire.com/news/home/20070104005533/en/Biogen-Idec-Acquire-Syntonix|access-date=2017-12-28|website=Businesswire|language=en}}</ref> In 2008, two new brain infection cases from [[Tysabri]] users surfaced in [[Europe]] that raised international concern about Tysabri and its effects with the progressive multifocal [[leukoencephalopathy]] (PML) brain condition. Biogen is one of the drug's producers.<ref>{{Cite web|title=Health Highlights: August 1, 2008|url=https://abcnews.go.com/Health/Healthday/story?id=5499620&page=1|access-date=2021-09-11|website=ABC News|language=en}}</ref> In 2011, Biogen announced that its drug Fampyra received conditional [[marketing approval]]. Under the conditional approval, Biogen agrees to provide additional data on the long-term benefits and safety of Fampyra.<ref name=":2">{{Cite web|title=TMX Money|url=https://money.tmx.com/fr/quote/BIIB:US/news/5008553463177966|access-date=2021-10-05|website=money.tmx.com}}</ref> On December 10, 2012, Biogen announced its global collaboration agreement with [[Isis Pharmaceuticals]] to develop and research [[antisense drugs]] to treat [[Neurological disorder|neurological]] and [[neuromuscular disease]]s.<ref>{{Cite web|title=Biogen Idec and Isis Pharmaceuticals Announce Collaboration For Antisense Programs To Treat Neurological Disorders {{!}} Ionis Pharmaceuticals, Inc.|url=https://ir.ionispharma.com/news-releases/news-release-details/biogen-idec-and-isis-pharmaceuticals-announce-collaboration|access-date=2021-10-05|website=ir.ionispharma.com|language=en}}</ref> In February 2013, [[Bloomberg L.P.|Bloomberg]] broke the news that Biogen was planning to pay [[Élan|Elan]] $3.25 billion for the full rights to [[Tysabri]], used to treat multiple sclerosis.<ref>{{Cite news|date=2013-02-06|title=Biogen to Pay Elan $3.25 Billion for Full Tysabri Rights|work=Bloomberg|url=https://www.bloomberg.com/news/articles/2013-02-06/biogen-to-pay-elan-3-25-billion-for-full-tysabri-rights|access-date=2017-12-28}}</ref> In 2013, Biogen was the first U.S.-based biotechnology company to appear on the [[Dow Jones Sustainability Indices|Dow Jones Sustainability World Index]].<ref>{{Cite web |date=2021-11-15 |title=Biogen Sets Industry Record with Recognition on Dow Jones Sustainability World Index for 9th Consecutive Year – Company Announcement |url=https://markets.ft.com/data/announce/full?dockey=1330-8393533en-7AVF3T95H006AM8BJAQF09HLDI |access-date=2024-09-09 |website=Financial Times}}</ref> 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 [[Raxatrigine|CNV1014802]] – a Phase II small molecule sodium channel blocking candidate.<ref>{{cite web|url=http://www.genengnews.com/gen-news-highlights/biogen-idec-snaps-up-convergence-for-up-to-675m/81250789/|title=Biogen Idec Snaps Up Convergence for Up-to-$675M - GEN News Highlights - GEN|date=12 January 2015 }}</ref> In October 2015, the company announced that it would lay off 11% of its workforce, effective immediately.<ref>{{cite web|url=http://www.businessinsider.com/biogen-layoffs-cutting-11-of-workforce-2015-10|title=Biogen is cutting 11% of its workforce|website=[[Business Insider]] }}</ref> On May 3, 2016, Biogen announced to spin off its hemophilia business, known as [[Bioverativ]]. The hemophilia business would become an independent publicly traded company. Bioverativ offered two hemophilia drugs in 2016, Alprolix and Eloctate, and plans on developing its Hemophilia-focused goals.<ref>{{Cite web|date=2016-05-03|title=Biogen puzzles Wall Street with plans to spin off its hemophilia business|url=https://www.statnews.com/pharmalot/2016/05/03/biogen-hemophilia-multiple-sclerosis/|access-date=2021-10-05|website=STAT|language=en-US}}</ref> 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.<ref>{{Cite news|author=Katie Thomas|url=https://www.nytimes.com/2016/12/30/business/spinraza-price.html|title=Costly Drug for Fatal Muscular Disease Wins F.D.A. Approval|work=The New York Times |date=31 December 2016 |language=en-us|access-date=2022-02-28}}</ref> 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. [[European Union|EU]] [[multiple sclerosis]] (MS) patients use Fampyra to improve walking.<ref name=":2" /> In February 2020, Biogen and [[Sangamo Therapeutics]] announced a global licensing deal to develop compounds for neuromuscular and neurological diseases.<ref>{{Cite web|url=https://www.biospace.com/article/biogen-and-sangamo-partner-on-alzheimer-s-parkinson-s-and-others/|title=Biogen and Sangamo Ink $2.7 Billion+ Neurodegeneration Deal|website=BioSpace|date=28 February 2020 |language=en-US|access-date=2020-02-28}}</ref> 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.<ref>{{Cite web|author=Staff Report|title=Biotech company partners with Black-owned bank|url=https://www.miamitimesonline.com/business/biotech-company-partners-with-black-owned-bank/article_04b90e0c-f2b2-11ea-9892-17c9cd391855.html|access-date=2020-09-13|website=The Miami Times|date=9 September 2020 |language=en}}</ref> 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 a number of depression treatments.<ref>[https://web.archive.org/web/20201127223831/https://uk.reuters.com/article/us-biogen-sage/biogen-bets-on-depression-drug-in-1-5-billion-deal-with-sage-therapeutics-idUKKBN2871GU Reuters]</ref> In July 2023, it was announced Biogen had acquired the [[Plano, Texas]]-headquartered biotech company, [[Reata Pharmaceuticals]] for nearly $6.5 billion.<ref>{{Cite news |last1=Mishra |first1=Manas |last2=Satija |first2=Bhanvi |last3=Satija |first3=Bhanvi |date=2023-07-28 |title=Biogen to buy Reata for $6.5 bln to bulk up rare disease portfolio |language=en |work=Reuters |url=https://www.reuters.com/markets/deals/biogen-buy-reata-65-bln-bulk-up-rare-disease-portfolio-2023-07-28/ |access-date=2023-07-28}}</ref> In May 2024, Biogen acquired Human Immunology Biosciences (HI-Bio) for $1.15 billion.<ref name="auto1">{{Cite web |title=Biogen bulking out mAb pipeline through $1.15bn HI-Bio buy |url=https://www.bioprocessintl.com/deal-making/biogen-bulking-out-mab-pipeline-through-1-15bn-hi-bio-buy |access-date=2024-05-23 |website=www.bioprocessintl.com |language=en}}</ref> === Aducanumab === {{Main|Aducanumab}} In 2007, the company reached a licensing agreement with Neurimmune, a spin-off from the University of Zurich, for the [[Alzheimer's disease]] drug, [[Aducanumab]], developed by this [[Switzerland|Swiss]] company. Later, Neurimmune sold its rights for license fees for $200 million to Biogen.<ref name="NZZ" /> 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.<ref>{{Cite news|last=Pierson|first=Ransdell|date=2014-12-02|title=Biogen plans late-stage Alzheimer's trial, shares rise|language=en|work=Reuters|url=https://www.reuters.com/article/us-biogen-idec-alzheimers-idINKCN0JG1JX20141202|access-date=2021-09-11}}</ref> 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.<ref>{{Cite news|last=Berkrot|first=Bill|date=2015-03-20|title=Biogen's Alzheimer's drug slows mental decline in early study|language=en|work=Reuters|url=https://www.reuters.com/article/us-biogen-alzheimers-idUSKBN0MG1OU20150320|access-date=2021-09-11}}</ref> In July 2015, Biogen initiated two late-stage studies called ENGAGE and EMERGE, which will assess Aducanumab in adults with early Alzheimer's disease.<ref>{{Cite web|date=2015-09-08|title=Biogen Enrolls First Patient in Global Phase 3 Study of Investigational Treatment Aducanumab (BIIB037) for Early Alzheimer's Disease|url=https://www.businesswire.com/news/home/20150908005533/en/Biogen-Enrolls-First-Patient-in-Global-Phase-3-Study-of-Investigational-Treatment-Aducanumab-BIIB037-for-Early-Alzheimer%E2%80%99s-Disease|access-date=2021-09-11|website=www.businesswire.com|language=en}}</ref> 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.<ref>{{Cite web|last=Kirsten|title=Investigational antibody treatment yields exciting though preliminary results - UCI MIND|url=https://mind.uci.edu/investigational-antibody-treatment-yields-exciting-though-preliminary-results/|access-date=2021-10-11|language=en-US}}</ref> On March 21, 2019, Biogen announced that the Phase 3 clinical trials of Aducanumab were halted.<ref>{{Cite web|last=Kirsten|title=Phase 3 Trials of Aducanumab Halted - UCI MIND|url=https://www.mind.uci.edu/phase-3-trials-of-aducanumab-halted/|access-date=2021-10-11|language=en-US}}</ref> 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.<ref>{{cite web|title=BIOGEN ANNOUNCES AGREEMENT TO ACQUIRE NIGHTSTAR THERAPEUTICS TO ESTABLISH CLINICAL PIPELINE OF GENE THERAPY CANDIDATES IN OPHTHALMOLOGY|url=https://www.biospace.com/article/biogen-announces-agreement-to-acquire-nightstar-therapeutics-to-establish-clinical-pipeline-of-gene-therapy-candidates-in-ophthalmology/|access-date=2 June 2019|website=BioSpace|date=4 March 2019 }}</ref><ref>{{cite web|title=Biogen Banks on Ophthalmology Gene Therapies With $800 Million Acquisition of Nightstar|url=https://www.biospace.com/article/biogen-banks-on-ophthalmology-gene-therapies-with-800-million-acquisition-of-nightstar/|access-date=2 June 2019|website=BioSpace|date=4 March 2019 }}</ref> With a setback in their drug research, Biogen's shares fell sharply that same month.<ref>{{cite web|last=Annett|first=Timothy|date=21 March 2019|title=Biogen shares plunge after Alzheimer's drug setback|url=https://www.bostonglobe.com/business/2019/03/21/biogen-shares-plunge-after-alzheimer-drug-setback/0MzLJWlEgmo5nHSKWl8esO/story.html|access-date=2 June 2019|work=The Boston Globe}}</ref> It ended the trial of Aducanumab, which it was making along with [[Eisai (company)|Eisai]].<ref>{{cite web|last=Li|first=Yun|date=21 March 2019|title=Biogen posts its the worst day in 14 years after ending trial for blockbuster Alzheimer's drug|url=https://www.cnbc.com/2019/03/21/biogen-shares-plunge-more-than-25percent-after-ending-trial-for-alzheimers-drug-aducanumab.html|access-date=2 June 2019|website=CNBC}}</ref> In October 2019, however, they announced that they would pursue FDA approval together with Eisai.<ref name=":0">{{Cite web|author1=Jacqueline Howard|author2=Jamie Gumbrecht|title=Drugmaker to seek approval for Alzheimer's treatment|url=https://www.cnn.com/2019/10/22/health/biogen-alzheimers-drug-fda/index.html|access-date=2019-10-23|website=CNN|date=22 October 2019 }}</ref> 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.<ref>{{Cite web|last=Chelsea|title=Biogen's About Face - UCI MIND|url=https://www.mind.uci.edu/biogens-about-face/|access-date=2021-10-11|language=en-US}}</ref> In May 2020, Biogen wrapped up construction on a state-of-the-art facility in [[Solothurn]], [[Switzerland]], which will produce Aducanumab by late 2021, alongside its [[North Carolina]] manufacturing facility. The [[monoclonal antibody]], co-developed with [[Eisai (company)|Eisai]], attracted considerable interest from biotech investors when [[Warren Buffett]]'s [[Berkshire Hathaway]] bought 648,447 Biogen shares at a combined value of $192.4 million.<ref>Kyle Blankenship (May 7, 2020). [https://www.fiercepharma.com/manufacturing/biogen-s-swiss-facility-wraps-up-construction-to-help-boost-aducanumab-rollout "Biogen gears up Swiss manufacturing facility for potential aducanumab rollout"] ''Fierce Pharma (Manufacturing)''. Retrieved 9 June 2021.</ref> On July 8, 2020, Biogen and [[Eisai (company)|Eisai]] announced that both companies had together successfully submitted for Aducanumab's FDA regulatory and marketing approval.<ref>{{Cite web|last=Kirsten|title=Biogen and Eisai submit aducanumab for FDA approval - UCI MIND|url=https://128.200.55.17/biogen-and-eisai-submit-aducanumab-for-fda-approval/|access-date=2021-10-11|language=en-US}}</ref> On June 7, 2021, the [[FDA]] gave accelerated approval to Aducanumab under the name Aduhelm,<ref>{{Cite web |last=Commissioner |first=Office of the |date=2021-06-07 |title=FDA Grants Accelerated Approval for Alzheimer's Drug |url=https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug |archive-url=https://web.archive.org/web/20210607153129/https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug |url-status=dead |archive-date=June 7, 2021 |access-date=2022-03-22 |website=FDA |language=en}}</ref> which proved to be controversial.<ref>{{Cite news |last1=Belluck |first1=Pam |last2=Kaplan |first2=Sheila |last3=Robbins |first3=Rebecca |date=2021-07-20 |title=How an Unproven Alzheimer's Drug Got Approved |language=en-US |work=The New York Times |url=https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html |access-date=2022-03-22 |issn=0362-4331}}</ref><ref>{{Cite web |last=Lovelace |first=Berkeley Jr. |date=2021-07-09 |title=Biogen stock falls after FDA calls for federal investigation into Alzheimer's drug approval |url=https://www.cnbc.com/2021/07/09/biogen-alzheimers-drug-fda-calls-for-federal-investigation-into-approval.html |access-date=2022-03-22 |website=CNBC |language=en}}</ref> 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.<ref>{{Cite web |last=King |first=Robert |date=2021-11-22 |title=Major insurers won't pay for Biogen's Alzheimer's drug until they get more proof that it works: Bloomberg survey |url=https://www.fiercehealthcare.com/payer/bloomberg-survey-major-insurers-question-if-controversial-alzheimer-s-drug-medically |access-date=2022-03-22 |website=Fierce Healthcare |language=en}}</ref> The US Government did not subsidise it outside clinical trials.<ref>{{Cite web |last=Liu |first=Angus |date=2022-01-12 |title=For Biogen's Aduhelm, narrow coverage from CMS 'could effectively spell the end': analyst |url=https://www.fiercepharma.com/marketing/biogen-alzheimer-s-drug-aduhelm-cms-restrictive-draft-reimbursement-ruling-could |access-date=2022-03-22 |website=Fierce Pharma |language=en}}</ref> 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.<ref>{{Cite news|last1=Steenhuysen|first1=Julie|last2=Beasley|first2=Deena|date=2021-06-08|title=U.S. approval of Biogen Alzheimer's drug sends shares soaring, hailed as 'big day" for patients|language=en|work=Reuters|url=https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-set-rule-controversial-biogen-alzheimers-drug-2021-06-07/|access-date=2021-10-11}}</ref> Biogen abandoned the drug in January 2024, for financial reasons.<ref>{{Cite web |title=Biogen will stop selling its controversial Alzheimer's drug Aduhelm |url=https://abcnews.go.com/Health/wireStory/biogen-plans-shut-controversial-alzheimers-drug-aduhelm-106827709 |access-date=2024-02-01 |website=ABC News |language=en}}</ref> ===Bioverativ=== In May 2016, the company announced that it would [[Corporate spin-off|spin off]] its hemophilia drug business ([[Eloctate]] and [[Alprolix]]) into a public company.<ref>{{cite news | url=https://www.reuters.com/article/us-biogen-hemophilia-idUSKCN0XU15E | title=Biogen to spin off hemophilia drug business into a public company | work=Reuters | date=May 3, 2016 | access-date=May 3, 2016 | author=D'Souza, Savio}}</ref> In August, the company announced that the spun off company would be called [[Bioverativ]], in order to show heritage with Biogen.<ref>{{cite web|url=http://www.fiercepharma.com/pharma/biogen-introduces-spinoff-bioverativ-amid-takeover-buzz|title=Amid takeover chatter, Biogen introduces hemophilia spinoff Bioverativ - FiercePharma|date=10 August 2016 }}</ref> The company would trade on the [[Nasdaq|NASDAQ]] exchange under the ticker symbol BIVV<ref>{{Cite press release|url=http://www.businesswire.com/news/financialpost/20160809005296/en/Biogen-Announces-Bioverativ-Hemophilia-Focused-Company|title=Biogen Announces Bioverativ as Name of New Hemophilia-Focused Company {{!}} Business Wire|website=Businesswire|language=en|access-date=2017-12-28}}</ref><ref>{{cite web|url=https://www.bostonglobe.com/business/2016/08/09/biogen-unveils-name-for-hemophilia-drug-spinoff-bioverativ/2EjLRgOOGpOZJECl3nO4yH/story.html|title=Biogen unveils name for hemophilia drug spinoff: Bioverativ |work=Boston Globe}}</ref> and would look to be spun off in early 2017.<ref>{{cite web|url=http://media.biogen.com/press-release/hemophilia-spin/biogen-announces-bioverativ-name-new-hemophilia-focused-company|title=Biogen Announces Bioverativ as Name of New Hemophilia-Focused Company - Biogen Media|access-date=2016-08-11|archive-url=https://web.archive.org/web/20160813045653/http://media.biogen.com/press-release/hemophilia-spin/biogen-announces-bioverativ-name-new-hemophilia-focused-company|archive-date=2016-08-13|url-status=dead}}</ref> Bioverativ was acquired by [[Sanofi]] in 2018 for about $11.6 billions<ref>{{cite web|url=https://www.globenewswire.com/news-release/2018/01/22/1298161/0/en/Sanofi-to-Acquire-Bioverativ-for-11-6-Billion.html|title=Sanofi to Acquire Bioverativ for $11.6 Billion|date=January 22, 2018|access-date=January 31, 2025|via=Sanofi|archive-url=https://archive.today/20250131210010/https://web.archive.org/web/20180123170819/https://www.globenewswire.com/news-release/2018/01/22/1298161/0/en/Sanofi-to-Acquire-Bioverativ-for-11-6-Billion.html|archive-date=January 31, 2025|url-status=live}}</ref><ref>{{cite web|author=Sudip Kar-Gupta|url=https://www.reuters.com/article/world/sanofi-digs-deep-to-buy-us-haemophilia-group-bioverativ-for-116-billion-idUSKBN1FB08C/|title=Sanofi digs deep to buy U.S. haemophilia group Bioverativ for $11.6 billion|date=January 22, 2018|publisher=[[Reuters]]|access-date=January 31, 2025|archive-url=https://archive.today/20250131210455/https://www.reuters.com/article/world/sanofi-digs-deep-to-buy-us-haemophilia-group-bioverativ-for-116-billion-idUSKBN1FB08C/|archive-date=January 31, 2025|url-status=live}}</ref><ref>{{cite web|url=https://www.france24.com/en/20180122-sanofi-buys-us-haemophilia-treatment-firm-116-bn-0|title=Sanofi buys US haemophilia treatment firm for $11.6 bn|location=Paris|publisher=AFP|access-date=January 31, 2025|date=January 22, 2018|archive-url=https://archive.today/20250131211047/https://web.archive.org/web/20201109014437/https://www.france24.com/en/20180122-sanofi-buys-us-haemophilia-treatment-firm-116-bn-0|archive-date=January 31, 2025|url-status=live}}</ref> ($105 per share in cash).<ref>{{cite web|url=https://www.sec.gov/Archives/edgar/data/1121404/000119312518074806/d538875dex991.htm|title=Sanofi Completes Acquisition of Bioverativ Inc.- Bioverativ Inc. is a fully owned subsidiary of Sanofi|location=Paris|date=March 8, 2018|archive-url=https://archive.today/20250131210315/https://www.sec.gov/Archives/edgar/data/1121404/000119312518074806/d538875dex991.htm|archive-date=January 31, 2025|url-status=live}}</ref> ===Acquisition history=== The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list): {{Tree list}} *'''Biogen''' **Biogen IDEC ***Biogen <small>(Est 1978)</small> ***IDEC Pharmaceuticals **Conforma Therapeutics <small>(Acq 2006)</small> **Fumapharm AG <small>(Acq 2006)</small> **Syntonix Pharmaceuticals <small>(Acq 2007)</small> **Convergence Pharmaceuticals <small>(Acq 2015)</small> **Nightstar Therapeutics <small>(Acq 2019)</small> **[[Reata Pharmaceuticals]] <small>(Acq 2023)</small> **Human Immunology Biosciences (HI-Bio) <ref name="auto1" /> {{Tree list/end}} === COVID-19 pandemic === {{See also|COVID-19 pandemic}} On March 5, 2020, Biogen reported that three individuals who met with their employees at a conference in [[Boston]] had tested positive for [[COVID-19]] the previous week.<ref>{{Cite web|title=3 Who Attended Biogen Meeting in Boston Test Positive for Coronavirus|url=https://www.nbcboston.com/news/local/3-who-attended-biogen-meeting-in-boston-test-positive-for-coronavirus/2086462/|access-date=2020-03-09|website=NBC Boston|date=5 March 2020 |language=en-US}}</ref> On March 6, public health officials reported five new cases associated with the Biogen leadership meeting<ref>{{Cite web|title=Coronavirus Cases Linked to Biogen Boston Meeting: What We Know|url=https://www.nbcboston.com/news/coronavirus/what-we-know-about-the-coronavirus-cases-linked-to-biogens-boston-meeting/2086974/|access-date=2020-03-09|website=NBC Boston|date=6 March 2020 |language=en-US}}</ref><ref>{{Cite web|date=2020-03-06|title=Workers who attended Boston Biogen meeting test positive for coronavirus|url=https://www.wcvb.com/article/workers-who-attended-boston-biogen-meeting-test-positive-for-coronavirus/31252079|access-date=2020-03-09|website=WCVB|language=en}}</ref> and by March 9, Massachusetts health officials had announced 30 new presumptive COVID-19 cases, all connected to the Biogen conference.<ref>{{Cite web|title=Live updates: Multiple Mass. schools closed Monday after 15 new presumptive positive COVID-19 cases reported|url=https://www.boston25news.com/more/blog-latest-coronavirus-cases-news-massachusetts/XZXJA7P3J5ENZFXLRG2YUFWTSI/|access-date=2020-03-09|website=WFXT|language=en-US}}</ref><ref>{{Cite web|date=2020-03-06|title=Top Biogen execs were at meeting where attendees had Covid-19|url=https://www.statnews.com/2020/03/06/biogen-workers-test-positive-for-coronavirus-transmission-linked-to-leadership-meeting/|access-date=2020-03-09|website=STAT|language=en-US}}</ref> Researchers first estimated that the conference would be linked to over 20,000 of the state's [[COVID-19|coronavirus]] cases.<ref>{{Cite web|date=2020-08-25|title=Biogen Conference May Be Tied To 20,000 Massachusetts Coronavirus Cases|url=https://boston.cbslocal.com/2020/08/25/biogen-conference-boston-massachusetts-coronavirus-20000-covid-19/|access-date=2020-08-25|website=CBS Boston|language=en-US}}</ref><ref name=":1" /> 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 of the coronavirus.<ref name=":1">{{Cite web|title=Genetic 'Fingerprints' Suggest Superspreader Biogen Conference Seeded 40% Of Boston Coronavirus Cases|url=https://www.wbur.org/news/2020/08/25/genetic-fingerprints-biogen-superspreader-boston|access-date=2021-09-27|website=www.wbur.org|date=25 August 2020 |language=en}}</ref> == Finances == 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$63 billion in November 2018.<ref>{{Cite web|title=Biogen Revenue 2006-2018 {{!}} BIIB|url=https://www.macrotrends.net/stocks/charts/BIIB/biogen/revenue|access-date=2018-11-05|website=Macro Trends}}</ref> The company ranked 228 on the 2021 [[Fortune 500]] list of the largest United States corporations by revenue.<ref>{{Cite web|url=http://fortune.com/fortune500/list/|title=Fortune 500 Companies 2021: Who Made the List|website=Fortune|language=en-US|access-date=2022-02-08|archive-date=2018-11-10|archive-url=https://web.archive.org/web/20181110190356/http://fortune.com/fortune500/list/|url-status=dead}}</ref> {| class="wikitable float-left" style="text-align: right;" !Year !Revenue<br />in mil. USD$ !Net income<br />in mil. USD$ !Total Assets<br />in mil. USD$ !Price per Share<br />in USD$ !Employees |- |2005 |2,423 |161 |8,382 |39.89 | |- |2006 |2,683 |218 |8,553 |42.39 | |- |2007 |3,172 |638 |8,629 |52.16 | |- |2008 |4,098 |783 |8,479 |51.09 | |- |2009 |4,377 |970 |8,552 |45.11 | |- |2010 |4,716 |1,005 |8,092 |51.95 | |- |2011 |5,049 |1,234 |9,050 |84.78 | |- |2012 |5,516 |1,380 |10,130 |125.83 | |- |2013 |6,932 |1,862 |11,863 |198.43 |6,850 |- |2014 |9,703 |2,935 |14,315 |293.10 |7,550 |- |2015 |10,764 |3,547 |19,505 |324.99 |7,350 |- |2016 |11,449 |3,703 |22,877 |258.27 |7,400 |- |2017 |12,274 |2,539 |23,653 |289.19 |7,300 |- |2018<ref>{{cite web|url=https://investors.biogen.com/static-files/30ea6b55-6a57-48ae-840d-96ac58ddf031 |title=2018 Annual Report |publisher=biogen.com |accessdate=17 March 2022}}</ref> |13,453 |4,431 |25,289 | |7,800 |- |2019<ref>{{cite web|url=https://investors.biogen.com/static-files/f86236ee-b489-461e-bb28-b7b4ccc4aeea |title=2019 Annual Report |publisher=biogen.com |accessdate=17 March 2022}}</ref> |14,378 |5,889 |27,234 | |7,400 |- |2020<ref>{{cite web|url=https://investors.biogen.com/static-files/0b109c48-3d3c-4554-8249-74b06c09797e |title=2020 Annual Report |publisher=biogen.com |accessdate=18 March 2022}}</ref> |13,445 |4,001 |24,619 | |9,100 |- |2021<ref name="auto2">{{cite web|url=https://www.statista.com/statistics/274272/revenue-and-net-income-of-biogen-idec/ |title=Biogen's revenue from 2007 to 2023 |publisher=statista.com |accessdate=23 May 2024}}</ref> |10,981 |1,556 |23,877 | | |- |2022<ref name="auto2" /> |10,173 |3,046 |24,554 | | |- |2023<ref name="auto2" /> |9,835 |1,161 |26,844 | | |} == Products == {|class="wikitable sortable" |- !Therapy!!Indication (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 Japanese [[Eisai (company)|Eisai]] are collaborators in the development and commercialization of LEQEMBI.<ref>{{Cite web |title=Companies in Alzheimer's race after US nod for Eisai/Biogen drug |url=https://www.reuters.com/business/healthcare-pharmaceuticals/companies-alzheimers-race-after-us-nod-eisaibiogen-drug-2023-07-07/ |website=Reuters}}</ref> |- |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 Japanese [[Eisai (company)|Eisai]] are collaborators in the development and commercialization of ADUHELM.<ref>{{cite web |url = https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf |title = ADUHELMTM (aducanumab-avwa) injection, for intravenous use, prescribing Information |publisher = FDA.gov |access-date=2021-06-09 }}</ref> |- |ALPROLIX™ [Coagulation [[Factor IX]] (Recombinant), Fc Fusion Protein]||Control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children with [[hemophilia B]]||2021 ||1993||Also approved in Canada and Australia. Biogen and Swedish Orphan Biovitrum (Sobi) are collaborators in the development and commercialization of ALPROLIX.<ref>{{cite web |url = http://www.fool.com/investing/general/2014/04/07/does-biogen-idec-inc-have-a-new-blockbuster-hemoph.aspx |title = Does Biogen Idec Inc Have a New Blockbuster Hemophilia Therapy? |date = 7 April 2014 |publisher = The Motley Fool |access-date=2014-07-04 }}</ref> |- |[[Avonex|AVONEX®]] ([[interferon beta-1a]])||Relapsing forms of [[multiple sclerosis]]||1996 ||1997 ||Includes the AVONEX PEN auto-injector and the AVOSTARTGRIP titration kit approved in the U.S. in 2012.<ref>{{cite web |url = http://www.nationalmssociety.org/Treating-MS/Medications/Avonex |title = Avonex |publisher = National MS Society }}</ref> |- |ELOCTATE™ [Antihemophilic Factor (Recombinant), Fc Fusion Protein]||Control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with [[hemophilia A]]||2014 ||1999||Biogen and Swedish Orphan Biovitrum (Sobi) are collaborators in the development and commercialization of ELOCTATE.<ref>{{cite web |url = http://www.thepharmaletter.com/article/biogen-idec-s-eloctate-gains-fda-approval |title = Biogen Idec's Eloctate gains FDA approval |publisher = The Pharma Letter |access-date=2014-09-06 }}</ref> |- |FAMPYRA (prolonged-release [[4-Aminopyridine|fampridine]] tablets)||[[Multiple sclerosis]] (Walking ability)||2010 ||2011 ||Marketed by Biogen in markets outside of the United States. Commercialized in the United States as AMPYRA (dalfampridine) Extended Release Tablets, by [[Acorda Therapeutics]].<ref>{{cite web |url = http://www.mstrust.org.uk/atoz/fampridine.jsp |title = Fampridine (Fampyra) |publisher = MS Trust }}</ref> |- |FUMADERM (fumaric acid esters)||[[Psoriasis]] German use || ||1994 (Germany only) ||Approved in Germany. Acquired in acquisition of Fumapharm AG in 2006.<ref>{{cite web |url = http://www.firstwordpharma.com/node/149468 |title = Biogen Idec enters deal to acquire Fumapharm |publisher = First Word Pharma |access-date=2006-05-31 }}</ref> |- |GAZYVA ([[obinutuzumab]])||[[Chronic lymphocytic leukemia]]||2013 ||2014 ||The 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.<ref>{{cite web|title=FDA approves Gazyva for chronic lymphocytic leukemia|url=https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm373209.htm|archive-url=https://web.archive.org/web/20131102162817/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373209.htm|url-status=dead|archive-date=November 2, 2013|access-date=2013-01-11|publisher=FDA}}</ref> |- |IMRALDI ([[adalimumab]]) |Immunosuppressive drug to treat autoimmune disorders such as [[inflammatory bowel disease]] |2019 |2018 |Biosimilar of [[AbbVie]]'s Humira.<ref>{{Cite web|title=FDA Approves Adalimumab Biosimilar, Samsung Bioepis' Hadlima|url=https://www.centerforbiosimilars.com/view/fda-approves-adalimumab-biosimilar-samsung-bioepis-hadlima|access-date=2021-06-07|website=The Center For Biosimilars|date=24 July 2019 }}</ref><ref>{{Cite web|title=IMRALDI™, Biogen's Adalimumab Biosimilar Referencing Humira®, Is Launched in the European Union {{!}} Biogen|url=http://media.biogen.com/news-releases/news-release-details/imralditm-biogens-adalimumab-biosimilar-referencing-humirar|access-date=2021-06-07|website=media.biogen.com|language=en}}</ref> |- |SPINRAZA ([[nusinersen]]) |[[Spinal muscular atrophy]] (SMA) |2016 |2017 |The first drug approved for the treatment of [[spinal muscular atrophy]], developed in collaboration with [[Ionis Pharmaceuticals]].<ref>{{cite journal|last1=Wadman|first1=Meredith|title=Updated: FDA approves drug that rescues babies with fatal neurodegenerative disease|journal=Science|date=23 December 2016|url=http://www.sciencemag.org/news/2016/12/novel-drug-rescues-babies-fatal-neurodegenerative-disease|doi=10.1126/science.aal0476|url-access=subscription}}</ref><ref>{{Cite news|url=https://www.wsj.com/articles/surprise-drug-approval-is-holiday-gift-for-biogen-1482856447|title=Surprise Drug Approval Is Holiday Gift for Biogen|last=Grant|first=Charley|date=2016-12-27|newspaper=Wall Street Journal|issn=0099-9660|access-date=2016-12-27}}</ref> |- |[[Plegridy|PLEGRIDY]] (peginterferon beta-1a)||Relapsing forms of multiple sclerosis||2014<ref>{{cite web |url = https://www.reuters.com/article/2014/08/15/ma-biogen-idec-idUSnBw155610a+100+BSW20140815 |title = Biogen Idec's PLEGRIDY(Peginterferon Beta-1a) Approved in the US for the Treatment of Multiple Sclerosis |publisher = Reuters |access-date = 2017-06-30 |archive-date = 2014-09-16 |archive-url = https://archive.today/20140916191335/http://www.reuters.com/article/2014/08/15/ma-biogen-idec-idUSnBw155610a+100+BSW20140815 |url-status = dead }}</ref> ||2014<ref>{{cite web |url = http://www.thepharmaletter.com/article/biogen-idec-s-plegridy-approved-in-europe-for-relapsing-remitting-multiple-sclerosis |title = Biogen Idec's Plegridy approved in Europe for relapsing-remitting multiple sclerosis |publisher = The Pharma Letter }}</ref> || |- |RITUXAN ([[rituximab]])||[[Non-Hodgkin lymphoma]] (NHL) Anti-TNF Refractory Rheumatoid Arthritis ANCA-Associated Vasculitis [[Chronic lymphocytic leukemia]] ||1997<ref>{{cite web |url = http://www.cancer.gov/cancertopics/druginfo/fda-rituximab |title = FDA Approval for Rituximab |publisher = National Cancer Institute }}</ref> 2006<ref>{{cite news |url = https://www.reuters.com/article/biogen-roche-idUSN2110240020101021 |title = UPDATE 1-Roche, Biogen end dispute over Rituxan follow-ons |date = 21 October 2010 |work = Reuters |access-date = 2010-10-21 |archive-date = 2014-07-27 |archive-url = https://web.archive.org/web/20140727222723/http://www.reuters.com/article/2010/10/21/biogen-roche-idUSN2110240020101021 |url-status = live }}</ref> 2011<ref>{{cite web|title=FDA approves Rituxan to treat two rare disorders|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm251946.htm|archive-url=https://web.archive.org/web/20110420004402/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm251946.htm|url-status=dead|archive-date=April 20, 2011|access-date=2011-04-19|publisher=FDA}}</ref> ||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 of [[multiple sclerosis]]||2013<ref>{{cite web |url = http://www.thepharmaletter.com/article/cell-therapeutics-buys-zevalin-from-biogen-idec-for-10m-with-up-to-20m-extra-plus-milestones |title = Cell Therapeutics buys Zevalin from Biogen Idec for $10M, with up to $20M extra plus milestones |publisher = The Pharma Letter |access-date=2007-09-03 }}</ref> ||2014<ref>{{cite web |url = http://www.nationalmssociety.org/Treating-MS/Medications/Tecfidera%E2%84%A2 |title = Tecifedra |publisher = National MS Society }}</ref> || |- |TYSABRI ([[natalizumab]])||Relapsing-remitting [[multiple sclerosis]]||2004 Re-introduced in 2006 ||2006 ||Full rights purchased from partner Elan in 2013.<ref>{{cite web |url = http://www.nationalmssociety.org/Treating-MS/Medications/Tysabri-%C2%AE |title = Tysabri |publisher = National MS Society }}</ref> |- |} == Pipeline == 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.{{citation needed|date=August 2021}} 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.<ref>{{cite web |url = http://www.fiercebiotech.com/story/once-monthly-ms-drug-biogen-idec-abbvie-clears-phase-iii-hurdle/2014-06-16 |title = Once-monthly MS drug from Biogen Idec, AbbVie clears Phase III hurdle |publisher = Fierce Biotech |access-date=2013-04-08 }}</ref> * 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.<ref>{{cite web |url = http://multiple-sclerosis-research.blogspot.com/2013/05/lingo-promising-remyelination-target-in.html |title = Lingo: a promising remyelination target in MS |publisher = Multiple Sclerosis Research |access-date=2014-06-16 }}</ref> 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<sub>Rx</sub>) 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.<ref name="auto3">{{cite web |url = http://www.fiercebiotech.com/special-reports/top-20-biotech-licensing-deals-h1-2012/isis-pharmaceuticals-and-biogen-idec |title = Isis Pharmaceuticals and Biogen Idec |publisher = Fierce Biotech }}</ref> 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.<ref>{{cite web |url = http://www.businessweek.com/news/2013-11-12/biogen-sees-eloctate-fda-delay-pushing-market-entry-to-mid-2014 |archive-url = https://archive.today/20140726132515/http://www.businessweek.com/news/2013-11-12/biogen-sees-eloctate-fda-delay-pushing-market-entry-to-mid-2014 |url-status = dead |archive-date = July 26, 2014 |title = Biogen Sees Eloctate FDA Delay Pushing Marketing to Mid-2014 |publisher = BusinessWeek |access-date=2013-12-11 }}</ref> 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.<ref name="auto3" /> 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.<ref>{{cite web|title=Biogen Offers Up To $1 Billion for AGTC's Ophthalmology Gene Therapy|work= Xconomy Boston|author= David Holley|date= July 2, 2015|url= http://www.xconomy.com/boston/2015/07/02/biogen-offers-up-to-1-billion-for-agtcs-ophthalmology-gene-therapy/}}</ref> 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.'"<ref>{{cite news |last1=Li |first1=Yun |title=Biogen shares plunge nearly 30% after ending trial for Alzheimer's drug Aducanumab |url=https://www.cnbc.com/2019/03/21/biogen-shares-plunge-more-than-25percent-after-ending-trial-for-alzheimers-drug-aducanumab.html |publisher=CNBC |date=21 March 2019}}</ref> 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.<ref name=":0" /> In July 2020, Biogen completed submission of a [[Biologics license application]] (BLA) to the FDA for review, and requested accelerated review.<ref>{{Cite web|title=Biogen submitted its Alzheimer's drug for approval. Now what?|url=https://www.biopharmadive.com/news/biogen-alzheimers-aducanumab-submit-fda/581233/|access-date=2020-07-29|website=BioPharma Dive|language=en-US}}</ref> However, an advisory panel for the FDA voted against approval of this drug.<ref>Pam Belluck: [https://www.nytimes.com/2020/11/06/health/aducanumab-alzheimers-drug-fda-panel.html?smid=tw-share ''F.D.A. Panel Declines to Endorse Controversial Alzheimer’s Drug.''] New York Times, November 6, 2020. Retrieved January 20, 2021.</ref> 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.<ref>{{Cite press release|title=FDA Grants Accelerated Approval for Alzheimer's Drug|date=7 Jun 2021|publisher=US Food & Drug Administration|url=https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug|archive-url=https://web.archive.org/web/20210607153129/https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug|url-status=dead|archive-date=June 7, 2021|access-date=7 Jun 2021}}</ref> ==Lawsuits== In September 2022, Biogen agreed to pay $900 million to the U.S. federal government, states, and a whistleblower. Biogen had [[Kickback (bribery)|bribed]] doctors between 2009 and 2014 to increase prescriptions of [[Avonex]], [[Tysabri]], and [[Tecfidera]] (all for [[multiple sclerosis]]).<ref>[https://www.bostonglobe.com/2022/09/26/business/biogen-pays-900m-settle-whistleblower-suit-over-kickbacks/ Biogen pays $900m to settle whistle-blower suit over kickbacks]</ref> == See also == * [[Neurological diseases]] * [[Kenneth Murray (biologist)|Kenneth Murray]] * [[Eisai (company)|Eisai]] * [[Tim Harris (biochemist)]] ==References== {{Reflist|2}} ==External links== *{{Official website}} {{Finance links | name = Biogen Inc. | symbol = BIIB | sec_cik = 875045 | yahoo = BIIB | google = BIIB:NASDAQ }} {{NASDAQ-100}} {{Pharmaceutical companies of the United States}} {{Authority control}} {{Portal bar|Companies}} {{coord|42|21|58.3|N|71|5|13.2|W|display=title}} [[Category:Companies based in Cambridge, Massachusetts]] [[Category:Biotechnology companies of the United States]] [[Category:National Medal of Technology recipients]] [[Category:Pharmaceutical companies of the United States]] [[Category:Pharmaceutical companies established in 2003]] [[Category:2003 establishments in Massachusetts]] [[Category:Life science companies based in Massachusetts]] [[Category:Life sciences industry]] [[Category:Swiss companies established in 1978]] [[Category:Pharmaceutical companies established in 1978]] [[Category:Biotechnology companies established in 1978]] [[Category:Spinal muscular atrophy]] [[Category:Health care companies based in Massachusetts]] [[Category:1991 initial public offerings]]
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