The history of Biogen Idec is the story of a passionate commitment to discover, develop and deliver important new therapies to patients.
Today, Biogen Idec is the oldest independent biotechnology company in the world. Patients worldwide benefit every day from its industry leading multiple sclerosis (MS) products. The company's R&D efforts are focused on bringing new therapies to market for patients with neurodegenerative diseases, autoimmune disorders and hemophilia.
- A group of the world's most accomplished biologists gather in Geneva, Switzerland to establish a new kind of pharmaceutical company. Founded with an emphasis on breakthroughs in biology, the scientists name the new company Biogen NV and begin work in small, separate labs around the world. This establishes the strong scientific heritage that continues today at Biogen Idec, and at the same time, helps signal the emergence of the biotech industry.
- Biogen scientists announce two groundbreaking discoveries: the expression of biologically active human leukocyte (alpha) interferon and biologically active human fibroblast (beta) interferon. Many years later, this pioneering work will ultimately lead to the development of AVONEX® (interferon beta-1a) used to treat MS.
- In the same year, Walter Gilbert, Ph.D., of Harvard University and a Biogen founder, is one of three scientists recognized with the Nobel Prize in Chemistry for their work in understanding the sequencing of DNA.
Two important steps are taken to firmly establish the company’s business position and create resources to further scientific discovery and development:
- First, Biogen offers 2.5 million shares of stock through its Initial Public Offering, becoming a NASDAQ-traded firm under the symbol BGEN. The company also officially opens its expanded U.S. facilities in Cambridge, Mass.
- By this time, the company already has research partnerships with key industry players, including Schering-Plough (now Merck).
- Silicon Valley venture capitalists join forces with a group of research scientists to establish IDEC Pharmaceuticals with the goal of developing and commercializing monoclonal antibodies. This new first target is a patient-specific, customized approach to treating non-Hodgkin's lymphoma (NHL).
Two important business milestones occur this year for Biogen:
- First, with an approval from the U.S. Food and Drug Administration (FDA), Schering-Plough begins commercial sales of INTRON® A (interferon alfa-2b), which marks the first product developed by Biogen to be brought to market. Licensed by Biogen a few years earlier, the product addresses an unmet need for patients affected by a rare form of leukemia.
- Second, Biogen Production is formally established to manufacture products. This initiative will mature into the company’s strong expertise in protein engineering and biologics manufacturing today.
- Both Biogen and IDEC experience significant business growth, setting the stage for the companies to further pursue scientific discovery and development. For Biogen, the company reports its first profitable quarter as a public company, while IDEC announces $11.5 million in partnerships to support ongoing programs to treat certain cancers of the immune system.
- Another scientific breakthrough reaches market when Biogen announces the FDA approval of its recombinant hepatitis B vaccine, which is licensed to SmithKline Beecham (now GlaxoSmithKline).
- Meanwhile, data published in the New England Journal of Medicine indicate that a significant portion of patients with B-cell lymphoma share certain tumor-associated "markers," which react with anti-idiotype antibodies initially made by IDEC as customized therapies for patients. This research leads to the discovery of a new compound, IDEC-C2B8, which is now known as RITUXAN® (rituximab).
- As Biogen celebrates its 15th anniversary, the company breaks ground for a major new facility in Cambridge, Mass., and a founder of Biogen, Phillip Sharp, Ph.D., receives the Nobel Prize in Medicine for his discovery of split genes. Another Biogen founder, Professor Kenneth Murray of the University of Edinburgh, is knighted for his discovery of hepatitis B antigens.
- Both Biogen and IDEC continue to see business growth. IDEC signs an important collaboration agreement with Genentech for further development and marketing of RITUXAN in the U.S. and Europe. At the same time, Biogen expands to Research Triangle Park, N.C., which will become a key location for the combined company.
- Biogen announces U.S. approval of AVONEX for the treatment of relapsing forms of MS. Healthcare professionals and patients widely accept AVONEX as an important new therapy, paving the way for thousands of people to receive safe and effective MS care.
AVONEX Full Prescribing Information
- The European Commission clears AVONEX for marketing and sales, helping to further advance Biogen’s position in the MS market and beginning the company’s expansion into Europe.
- The same year, RITUXAN, the first monoclonal antibody therapy for cancer, is also approved by the FDA for the treatment of certain types of B-cell NHL, marking a scientific breakthrough in cancer treatment and a major milestone in IDEC’s goal of treating patients using monoclonal antibodies.
RITUXAN Full Prescribing Information (PDF)
- Biogen and Elan Corporation, plc, announce collaboration on development and commercialization of TYSABRI® (natalizumab), an innovative treatment for MS. The MS professional and patient communities see exciting potential in the product.
- Biogen introduces MS ActiveSource®, a comprehensive support service for patients and caregivers; these world-class services address the informational, emotional, financial and logistical needs that come with living with MS.
- Biogen opens one of the largest biologic manufacturing facilities in the world, a 90,000-liter large-scale manufacturing plant in Research Triangle Park, N.C. This facility will become a world-class operation, expanding science and innovation beyond the research lab.
- The company also starts its first Community Lab in Cambridge, Mass. The Community Lab serves as a state-of-the-art teaching facility for junior high and high school students in the local community. Students experience science first-hand and learn about the possibility of a career in science.
- A powerful global biotechnology leader is created when Biogen and IDEC merge, creating Biogen Idec (NASDAQ:BIIB). Then the third-largest biotechnology company in the world, the combined entity charts a course to sustain growth and bring innovative new therapies to market.
- As a result of the merger, the combined company boasts global reach with operations in 16 European countries and multiple aggressive drug development programs.
- Biogen Idec announces another significant company milestone with the U.S. approval of TYSABRI, a therapy shown to significantly reduce the risk of disability progression in patients with MS. This approval introduces another innovative treatment option to the MS community.
TYSABRI Full Prescribing Information (PDF)
- Biogen Idec opens new international headquarters in Zug, Switzerland, continuing efforts to expand its global footprint.
- Biogen Idec forms a strategic partnership with PDL BioPharma, later acquired by Abbott, to develop three antibody products. These antibodies include daclizumab, which is currently in development for MS.
- After the emergence of an infrequent but serious side effect known as progressive multifocal leukocenphalopathy (PML) in patients taking TYSABRI, Biogen Idec and Elan voluntarily remove TYSABRI from the marketplace. Biogen Idec works closely with the FDA to evaluate the risk profile for TYSABRI and develop a risk management program that will enable the product to be reintroduced.
- TYSABRI is reintroduced in the U.S. and launched in the European Union as a treatment for relapsing forms of MS after developing a risk management plan designed to inform physicians and patients of the benefits and risks of TYSABRI treatment and minimize the potential risk of PML.
- In keeping with the Biogen Idec mission to discover, develop and deliver innovative therapies for the treatment of neurodegenerative diseases, autoimmune disorders and hemophilia, the company acquires Syntonix Pharmaceuticals and announces an alliance with Neurimmune Therapeutics.
- The company continues its global expansion by opening offices in Brazil, China and India bringing the direct commercial presence to 25 countries.
- The FDA approves the company's high-titer process for the production of TYSABRI, reflecting the company’s significant strength in biologics manufacturing.
- Forbes magazine places Biogen Idec in the top-five of "Global High Performers" in the Drug & Biotechnology industry.
- Demonstrating commitment to its local communities, the Biogen Idec Foundation announces its largest grant to-date, with an award of $1 million in a Transformational Grant in Science Education to the North Carolina Biotechnology Center.
- Biogen Idec refines its business strategy by focusing on new therapies in neurology, immunology and hemophilia. By allocating resources to these therapeutic areas where the company has the most expertise and the most promising assets, Biogen Idec positions itself to best deliver meaningful benefits for patients and shareholders.
- The company also expands its R&D pipeline in neurodegenerative diseases. The company acquires a subsidiary of Neurimmune Holding AG, bringing in three pre-clinical compounds and enters into a licensing agreement with Knopp Neurosciences, which brings in dexpramipexole in development for ALS.
- Biogen Idec announces positive results from two Phase III clinical trials – DEFINE and CONFIRM – that evaluate the efficacy, safety and tolerability of its oral product candidate, BG-12 (dimethyl fumarate), now TECFIDERA® in relapsing-remitting MS (RRMS).
- The AVONEX® PEN™ is launched in the European Union and Canada.
- FAMPYRA® (prolonged-release fampridine tablets) is approved in Europe and launches in Australia, Denmark, Germany, Norway and the United Kingdom.
- Two significant business development deals are announced:
- The first is with Portola Pharmaceuticals to develop and commercialize a highly selective Syk inhibitor oral therapy for rheumatoid arthritis, lupus and other autoimmune diseases.
- The second transaction marks the Company’s entry into biosimilars, through an agreement with Samsung Biologics to fund a joint venture known as Samsung Bioepsis formed to develop, manufacture and market biosimilars.
- Biogen Idec holds its first annual “Care Deeply Volunteer Day,” which pairs more than 1,000 employees around the globe with charitable projects in local communities where the Company does business.
- The FDA approves two separate dosing innovations designed to improve the treatment experience for patients receiving once-a-week AVONEX: the AVONEX PEN and AVOSTARTGRIP®. These new dosing innovations become available in the United States in May 2012.
AVONEX Full Prescribing Information
- Biogen Idec submits applications to the FDA and the European Medicines Agency (EMA) for approval of oral BG-12 (dimethyl fumarate), now TECFIDERA®, to treat MS.
- Biogen Idec and Swedish Orphan Biovitrum AB (publ) (Sobi) announce positive top-line results from a Phase 3 study investigating long-lasting recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B, now ALPROLIX™, in which the primary efficacy and safety objectives were met.
- Biogen Idec helps to create a new research consortium in collaboration with several leading academic research centers intended to leverage a range of scientific techniques and disciplines to identify new approached to treating ALS.
- Biogen Idec, together with the National Hemophilia Foundation, the American Thrombosis and Hemostasis Network, Puget Sound Blood Center, announce My Life, Our Future: Genotyping for Progress in Hemophilia, a nationwide program that will offer free genetic testing to people with hemophilia and their families.
- Biogen Idec holds its second annual “Care Deeply Volunteer Day,” sending out volunteers in 22 countries around the world.
- Biogen Idec announces several business development agreements, including:
- A collaboration with Isis Pharmaceuticals, Inc. (Isis) to discover and develop scientific techniques and disciplines to identify new approaches to treating antisense drugs to treat spinal muscular atrophy (SMA), myotonic dystrophy type 1, and neurological or neuromuscular disorders.
- The acquisition of Stromedix, a biotechnology company focused on innovative therapies for fibrosis and organ failure.
- TECFIDERA (dimethyl fumarate), a new oral therapy for relapsing forms of multiple sclerosis, is approved in the United States, Canada, and Australia.
TECFIDERA Full Prescribing Information (PDF)
- Biogen Idec completes its acquisition of all rights to TYSABRI from Elan Pharmaceuticals International, Ltd., an affiliate of Elan Corporation, which had been co-marketed by the companies since 2004 in the United States.
- GAZYVA® obtains approval for chronic lymphocytic leukemia (CLL) in the United States - the first drug to be approved by the FDA with breakthrough therapy designation. GAZYVA was developed and commercialized in collaboration with Genentech, a wholly owned subsidiary of Roche Pharmaceuticals.
GAZYVA Full Prescribing Information (PDF)
- The FDA and EMA approved the manufacturing of TYSABRI at Biogen Idec’s large-scale manufacturing facility in Hillerød, Demark beginning in October 2013 to produce TYSABRI for patients who live outside the United States.
- Biogen Idec moves its company headquarters back to Cambridge, Massachusetts, on the site of the original Biogen offices.
- The Company hosts its third annual “Care Deeply Volunteer Day,” with more than 1,900 employees volunteering in 28 countries around the world.
- Biogen Idec enters several collaboration agreements, including agreements with:
- Isis Pharmaceuticals to leverage antisense technology to accelerate discovery and development of novel therapies for treatment of neurological disorders, marking the fourth collaboration between the two companies in the past two years;
- Galapagos NV subsidiary BioFocus, which focuses on the identification and validation of novel targets in scleroderma, an autoimmune disease characterized by the hardening of the skin.
- Additionally, Biogen Idec announced plans to exercise its right to commercialize anti-TNF biosimilar product candidates in Europe through the joint venture with Samsung Bioepis.
- TECFIDERA is approved by the European Commission (EC) as a first-line oral treatment for multiple sclerosis. Biogen Idec begins roll out in the European Union.
- The FDA approves Biogen Idec’s two hemophilia therapies, ALPROLIX™ for the treatment of hemophilia B and ELCOTATE™ for the treatment of hemophilia A, providing patients the first new in treatment advances for these diseases in nearly two decades.
ALPROLIX Full Prescribing Information (PDF)
ELOCTATE Full Prescribing Information (PDF)
- PLEGRIDYTM (peginterferon beta-1a) is approved by the FDA for the treatment of people with relapsing forms of MS (RMS) and by the EC for RRMS.
PLEGRIDY Full Prescribing Information (PDF)
- With partner Abbvie, Biogen Idec announces positive top-line results from the Phase III DECIDE clinical trial, where DAC HYP demonstrated superiority over interferon beta-1a in annualized relapse rate.
- In collaboration with Sobi, Biogen Idec announces its intent to donate up to one billion international units of clotting factor therapy for humanitarian aid programs in the developing world.
- Biogen Idec enters several collaboration agreements, including agreements with:
- Sangamo BioSciences, Inc. in an exclusive worldwide collaboration and license agreement focused on the development of therapeutics for hemoglobinopathies.
- Eisai, Inc., to jointly develop and commercialize two of their candidates for Alzheimer’s disease;