Biogen Inc. is an American multinationalbiotechnology 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]
In 2003, Biogen merged with San Diego, California-based IDEC Pharmaceuticals (formed in 1985 by 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.[5][6] After the merger, Biogen Idec became the 3rd largest Biotechnology company in the world.[7]
Following shifts in research core areas, the company has since shortened its name, reverting to simply Biogen.[8] 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.[9]
In May 2006, the company announced it would acquire cancer specialist, Conforma Therapeutics for $250 million.[10] 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.[11]
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.[12][13]
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.[14]
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.[15]
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.[17]
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.[18] In October 2015, the company announced that it would lay off 11% of its workforce, effective immediately.[19]
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.[20]
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.[21] 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.[15]
In February 2020, Biogen and Sangamo Therapeutics announced a global licensing deal to develop compounds for neuromuscular and neurological diseases.[22]
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.[23] 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.[24]
In July 2023, it was announced Biogen had acquired the Plano, Texas-headquartered biotech company, Reata Pharmaceuticals for nearly $6.5 billion.[25]
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 Swiss company. Later, Neurimmune sold its rights for license fees for $200 million to Biogen.[3]
In December 2014, Biogen announced that its Aducanumab drug for Alzheimer's treatment is 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.[26]
In March 2015, Biogen's Aducanumab drug for Alzheimer's treatment becomes the first experimental Alzheimer's treatment to show significant results in regard to slowing down cognitive decline and reducing brain-destroying plaques.[27]
In July 2015, Biogen initiates two late-stage studies called ENGAGE and EMERGE, which will assess Aducanumab in adults with early Alzheimer's disease.[28]
In 2016, Biogen's Aducanumab decreases amoyloid-beta in the brains of people with early-stage Alzheimer's disease, according to a report published in Nature on August 31, 2016.[29]
On March 21, 2019, Biogen announced that the Phase 3 clinical trials of Aducanumab were halted.[30]
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.[31][32] With a setback in their Alzheimer's drug research, in March 2019 Biogen's shares fell sharply.[33] It ended the trial of its drug aducanumab, which it was making along with Eisai.[34] In October 2019, however, they announced that they would pursue FDA approval for aducanumab together with Eisai.[35]
On October 22, 2019, despite two Phase 3 clinical trials being previously halted for futility, Biogen announced its plan to submit for the FDA's approval of Aducanumab.[36]
In May 2020, Biogen wrapped up construction on a state-of-the-art facility in Solothurn, Switzerland, which will produce the Alzheimer's drug aducanumab by late 2021, alongside its North Carolina manufacturing facility. The monoclonal antibody, co-developed with 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.[37]
On July 8, 2020, Biogen and Eisai announced that both companies had together successfully submitted for Aducanumab's FDA regulatory and marketing approval.[38]
On June 7, 2021, the FDA gave accelerated approval to aducanumab under the name Aduhelm,[39] which proved to be controversial.[40][41] The drug was priced at $56,000 US dollars per year but it is not covered by many insurers as they wait for further proof that the drug is effective.[42] Also the US Government will not subsidise it outside clinical trials.[43] According to the Food and Treatment Administration's website, the drug is proven to reduce amyloid-beta plaques in the brain, which is likely to benefit patients. The FDA has stated that if the post-approval trial does not indicate that Aduhelm works, the drug may be taken out of the market.[44]
Bioverativ
In May 2016, the company announced that it would spin off its hemophilia drug business (Eloctate and Alprolix) into a public company.[45] In August, the company announced that the spun off company would be called Bioverativ, in order to show heritage with Biogen.[46] The company would trade on the NASDAQ exchange under the ticker symbol BIVV[47][48] and would look to be spun off in early 2017.[49] Bioverativ was acquired by Sanofi in 2018.
Acquisition history
The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):
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.[50] On March 6, public health officials reported five new cases associated with the Biogen leadership meeting[51][52] and by March 9, Massachusetts health officials had announced 30 new presumptive COVID-19 cases, all connected to the Biogen conference.[53][54] Researchers first estimated that the conference would be linked to over 20,000 of the state's coronavirus cases.[55][56] 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.[56]
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.[57] The company ranked 228 on the 2021 Fortune 500 list of the largest United States corporations by revenue.[58]
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 are collaborators in the development and commercialization of ADUHELM.[63]
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.[64]
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.[69]
Full rights purchased from partner Elan in 2013.[81]
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]
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.[82]
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.[83]
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
Biogen also has several development agreements in place with Ionis Pharmaceuticals to collaborate to leverage antisense technology in advancing the treatment of neurological disorders.[84]
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.[85]
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.[86]
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.[87]
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.'"[88] 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.[89] However, an advisory panel for the FDA voted against approval of this drug.[90] 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.[91]
Lawsuits
In September 2022, Biogen agreed to pay $900 million to the U.S. federal governments, states, and a whistleblower. Biogen had bribed doctors between 2009 and 2014 to increase prescriptions of Avonex, Tysabri, and Tecfidera (all for multiple sclerosis).[92]
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered at The Spiral in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891).
The Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company, with partial American and British roots. It is the third largest pharmaceutical company in Asia, behind Sinopharm and Shanghai Pharmaceuticals, and one of the top 20 largest pharmaceutical companies in the world by revenue. The company has over 49,578 employees worldwide and achieved US$19.299 billion in revenue during the 2018 fiscal year. The company is focused on oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies and vaccines. Its headquarters is located in Chuo-ku, Osaka, and it has an office in Nihonbashi, Chuo, Tokyo. In January 2012, Fortune Magazine ranked the Takeda Oncology Company as one of the 100 best companies to work for in the United States. As of 2015, Christophe Weber was appointed as the CEO and president of Takeda.
Daclizumab is a therapeutic humanized monoclonal antibody which was used for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab works by binding to CD25, the alpha subunit of the IL-2 receptor of T-cells.
F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the fifth-largest pharmaceutical company in the world by revenue and the leading provider of cancer treatments globally.
Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France. The corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004, Sanofi-Synthélabo merged with Aventis and renamed to Sanofi-Aventis, which were each the product of several previous mergers. It changed its name back to Sanofi in May 2011. The company is a component of the Euro Stoxx 50 stock market index.
Elan Corporation plc was a major drugs firm based in Dublin, Ireland, which had major interests in the United States. It was listed on the New York Stock Exchange as ELN, the Irish Stock Exchange as ELN.I, and the London Stock Exchange as ELN.L. In 2013, the company merged with Perrigo to form Perrigo Company PLC.
Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. One of the world's largest independent biotechnology companies, Amgen's Thousand Oaks staff in 2022 numbered approximately 5,000 and included hundreds of scientists, making Amgen the largest employer in Ventura County. As of 2022, Amgen has approximately 24,000 staff in total.
Antisense therapy is a form of treatment that uses antisense oligonucleotides (ASOs) to target messenger RNA (mRNA). ASOs are capable of altering mRNA expression through a variety of mechanisms, including ribonuclease H mediated decay of the pre-mRNA, direct steric blockage, and exon content modulation through splicing site binding on pre-mRNA. Several ASOs have been approved in the United States, the European Union, and elsewhere.
Natalizumab, sold under the brand name Tysabri among others, is a medication used to treat multiple sclerosis and Crohn's disease. It is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin. It is given by intravenous infusion. The drug is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood–brain barrier.
4-Aminopyridine (4-AP, fampridine, dalfampridine) is an organic compound with the chemical formula C5H4N–NH2. The molecule is one of the three isomeric amines of pyridine. It is used as a research tool in characterizing subtypes of the potassium channel. It has also been used as a drug, to manage some of the symptoms of multiple sclerosis, and is indicated for symptomatic improvement of walking in adults with several variations of the disease. It was undergoing Phase III clinical trials as of 2008, and the U.S. Food and Drug Administration (FDA) approved the compound on January 22, 2010. Fampridine is also marketed as Ampyra (pronounced "am-PEER-ah," according to the maker's website) in the United States by Acorda Therapeutics and as Fampyra in the European Union, Canada, and Australia. In Canada, the medication has been approved for use by Health Canada since February 10, 2012.
On July 1, 2023, Sunovion Pharmaceuticals Inc. became part of Sumitomo Pharma America, Inc., a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry and neurology, oncology, urology, women's health, rare disease, and cell and gene therapies.
Celgene Corporation is a pharmaceutical company that makes cancer and immunology drugs. Its major product is Revlimid (lenalidomide), which is used in the treatment of multiple myeloma, and also in certain anemias. The company is incorporated in Delaware, headquartered in Summit, New Jersey, and a subsidiary of Bristol Myers Squibb (BMS).
Astellas Pharma Inc. is a Japanese multinational pharmaceutical company, formed on 1 April 2005 from the merger of Yamanouchi Pharmaceutical Co., Ltd. and Fujisawa Pharmaceutical Co., Ltd.. On February 5, 2020, the company announced management changes effective from April 1, 2020.
Alnylam Pharmaceuticals, Inc. is an American biopharmaceutical company focused on the discovery, development and commercialization of RNA interference (RNAi) therapeutics for genetically defined diseases. The company was founded in 2002 and is headquartered in Cambridge, Massachusetts. In 2016, Forbes included the company on its "100 Most Innovative Growth Companies" list.
Aducanumab, sold under the brand name Aduhelm, is a medication designed to treat Alzheimer's disease (AD). It is a monoclonal antibody that targets aggregated forms (plaque) of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup. It was developed by Biogen and Eisai. Aducanumab is given via intravenous infusion.
Jazz Pharmaceuticals plc is a biopharmaceutical company based in Ireland. It was founded in 2003. One of the company's considerable products is the United States Food and Drug Administration (FDA) approved drug Xyrem, the sodium salt of the naturally occurring neurotransmitter γ-Hydroxybutyric acid (GHB). In 2017, net product sales of Xyrem were $1.187 billion, which represented 74% of the company's total net product sales. In 2019, Jazz was granted FDA-approval to market Sunosi with indications for treating excessive daytime sleepiness (EDS) in narcolepsy as well as obstructive sleep apnea (OSA). In 2022, it was announced that Axsome Therapeutics would be acquiring Sunosi from Jazz Pharmaceuticals
Ionis Pharmaceuticals, Inc. is a biotechnology company based in Carlsbad, California, that specializes in discovering and developing RNA-targeted therapeutics. The company has three commercially approved medicines: Spinraza (Nusinersen), Tegsedi (Inotersen), and Waylivra (Volanesorsen) and has four drugs in pivotal studies: tominersen for Huntington’s disease, tofersen for SOD1-ALS, AKCEA-APO(a)-LRx for cardiovascular disease, and AKCEA-TTR-LRx for all forms of TTR amyloidosis.
Bioverativ Inc. is an American multinational biotechnology company that specializes in the discovery, development, and delivery of therapies for the treatment of haemophilia. Bioverativ competes with Baxalta, Pfizer and Novo Nordisk. The company traded on the NASDAQ exchange under the ticker symbol BIVV until Sanofi completed its acquisition on March 8, 2018.
Lecanemab, sold under the brand name Leqembi, is a monoclonal antibody medication used for the treatment of Alzheimer's disease. Lecanemab is an amyloid beta-directed antibody. It is given via intravenous infusion. The most common side effects of lecanemab include headache, infusion-related reactions, and amyloid-related imaging abnormalities, a side effect known to occur with the class of antibodies targeting amyloid.
Ultragenyx is an American biopharmaceutical company involved in the research and development of novel products for treatment of rare and ultra-rare genetic diseases for which there are typically no approved treatments and high unmet medical need. The company works with multiple drug modalities including biologics, small molecule, gene therapies, and ASO and mRNAs in the disease categories of bone, endocrine, metabolic, muscle and CNS diseases.
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US$9.836 billion (2023)
US$26.84 billion (2023)
