Biogen (company)

Biogenic
legal form	Corporation
ISIN	US09062X1037
founding	1978 as Biogen NV
Seat	Cambridge, Massachusetts , USA
management	Michel Vounatsos, CEO , Stelios Papadopoulos, Chairman of the Board
Number of employees	> 7,300 (2015)
sales	14.4 billion US dollars (2019)
Branch	Biotechnology , pharmaceutical industry
Website	www.biogen.com

Biogen is a US biotechnology group based in Cambridge, Massachusetts. The group emerged from the company Biogen Idec , for which the companies Biogen (founded in 1978) and Idec Pharmaceuticals (founded in 1985) merged in 2003. Since March 2015 the company has been operating under the name of Biogen again worldwide.

Biogen works and researches in the areas of neurology , with a particular focus on multiple sclerosis , immunology and hematology . In Germany, Biogen sells a preparation for the treatment of psoriasis .

Total revenues in 2019 were approximately $ 14.4 billion. The company has offices in Australia, Europe, Japan and Canada. The international headquarters for markets outside the USA is located in Zug, Switzerland . Biogen employs more than 7,300 people worldwide.

The main growth supplement is Spinraza ( Nusinersen ).

Product development

The group uses recombinant DNA technology, also known as biotechnology . This makes it possible to produce human proteins and thus drugs with the help of microorganisms . The company continues to develop both new substances and molecules that have already been approved.

Company history

Biogen was founded as a Dutch company ( NV ) in 1978 by a group of internationally renowned European and American scientists . The founding members included the later Nobel Prize winners Walter Gilbert ( Nobel Prize in Chemistry 1980) and Phillip Sharp (Nobel Prize in Medicine 1993) as well as the scientists Heinz Schaller and Charles Weissmann . The first successes soon became apparent in the development of recombinant vaccines against the viral pathogens of hepatitis B (HBV, with Kenneth Murray , EMBL / Edinburgh) and foot and mouth disease (MKSV, with Peter Hans Hofschneider , Martinsried).

Initially, Biogen did not have its own sales capacities: In 1980, a process developed by Biogen for the production of alpha interferon was out - licensed to the Schering-Plow company (now MSD ). In 1989, the vaccine against hepatitis B manufactured by SmithKline Beecham (now GSK ), the production of which is based on a genetic engineering process patented by Biogen, was launched.

In 1983 Biogen went public on the NASDAQ . Idec Pharmaceuticals was founded in 1985 in San Francisco, California (USA) and went public in 1991. In 2003, Biogen and Idec Pharmaceuticals merged to form Biogen Idec.

In 2006, Biogen Idec took over Fumapharm AG and its fumaric acid esters for the treatment of psoriasis , as well as the oral fumarate derivative that is in clinical trials (as of 2011).

Since March 2015, the company has been operating under the name of Biogen again worldwide.

Wolfram Schmidt is the managing director of the German branch, Biogen GmbH in Munich.

Medication

• Alprolix ^® (active ingredient: eftrenonacog alfa) is a recombinant fusion protein (rFIXFc) for the treatment of haemophilia B , developed in collaboration with Swedish Orphan Biovitrum AB (Sobi) , was initially only approved in the USA, Canada and Australia. It has been approved in the EU since 2016.

• Avonex ^® (active ingredient: Interferon beta-1a ) has been used since 1996 for the treatment of relapsing multiple sclerosis (MS) and / or for treatment after a one-off demyelinating event with an inflammatory process. Avonex ^® PEN ^TM , lyophilisate (dry substance) and pre-filled syringe are available as dosage forms . It was the first product sold by Biogen itself.

• Benepali ^® , the first anti-TNF-α biosimilar to etanercept (Enbrel ^® ) for the treatment of adults with moderate to severe rheumatoid arthritis (RA) , psoriatic arthritis , axial spondyloarthritis and plaque psoriasis was launched by Biogen in Germany in March 2016 .

• Eloctate ^® (active ingredient: Efraloctocog alfa) is a recombinant fusion protein (rFVIIIFc) for the treatment of haemophilia A , which is sold in Europe by Sobi.

• Fampyra ^® (active ingredient: fampridine ) is the first drug to improve the walking ability of adult MS patients (EDSS 4 - 7) in all forms of MS.

• Flixabi ^® , a biosimilar to infliximab (Remicade ^® ), was approved in the EU in May 2016 for the treatment of adults with rheumatoid arthritis (RA) , Crohn's disease , ulcerative colitis, psoriatic arthritis , axial spondyloarthritis and psoriasis .

• Fumaderm ^® (active ingredient: dimethyl fumarate and calcium, magnesium and zinc salts of ethyl hydrogen fumarate) is approved for the treatment of moderate to severe forms of psoriasis vulgaris (psoriasis) , provided that external therapy alone is not sufficient.

• Plegridy ^® (active ingredient: peginterferon β-1a ) was approved for the treatment of multiple sclerosis in Europe in July 2014 and in the USA in August 2014 .

• SPINRAZA ^® (active ingredient: Nusinersen ) is approved in the USA and the EU for the treatment of spinal muscular atrophy (SMA) and was developed in collaboration with Ionis Pharmaceuticals .

• Tecfidera ^® (active ingredient: dimethyl fumarate ) is approved in the EU for the oral treatment of relapsing-remitting MS .

• Tysabri ^® (active ingredient: natalizumab ) was developed as the first monoclonal antibody for the treatment of multiple sclerosis in cooperation with Elan Corporation . Tysabri ^® was withdrawn from the market in February 2005 by Biogen Idec in consultation with the FDA due to three cases of progressive multifocal leukoencephalopathy (PML) . On June 6, 2006, Tysabri ^{® was} re-approved by the FDA after extensive reviews of all patients previously treated with Tysabri ^® . On June 27, 2006, the European approval was also granted by the European Commission and subsequently Tysabri ^{® was} first launched on the German market.

• The active ingredient rituximab was developed by Idec Pharmaceuticals (see introduction, i.e. before the merger with Biogen) together with Genentech and is the first anti-cancer therapeutic agent based on a monoclonal antibody for the treatment of certain forms of B-cell non-Hodgkin lymphoma (NHL). The antibody is directed against the CD20 antigen , which is found on normal and malignant lymphocytes . The trade name in the USA is Rituxan ^® . In Europe, Roche markets Rituximab under the trade name MabThera ^® .

• Obinutuzumab was also developed with Genentech and is approved in the United States for the treatment of chronic lymphatic leukemia (CLL) . It is marketed there by Genentech under the trade name Gazyva ^® .

• The monoclonal antibody daclizumab (MS) was withdrawn from the market worldwide in March 2018 due to unacceptable side effects.

pipeline

Biogen conducts research in the indications CLL , hemophilia , MS and spinal muscular atrophy (SMA) and has numerous product candidates in clinical research. The following preparations are already in the approval process:

• Research on the monoclonal antibody aducanumab (Alzheimer's) was discontinued in March 2019 due to a lack of endpoint data. The discontinuation of Biogen's most prominent and arguably most complex development project resulted in a reduction in the market value of 17 billion dollars in one day. In October 2019, it was announced that Biogen - based on a new analysis of the data - wanted to submit an application to the US FDA .

The following parts of this article appear since 2017 is out of date to be : in the meantime admitted Partly partially withdrawn from the market
Please help with to the missing information research and insert .

• Biogen also has other biosimilars in the pipeline, such as: B. adalimumab (Humira ^® ).

Web links

• The Headquarters site (English)
• Website of the international company (English)
• German company website (German)

Individual evidence

1. ↑ ^{a b c d e} History - A biotech pioneer ( Memento of the original from April 2, 2015 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , global website biogen.com, accessed on February 25, 2016 from the 
2. ↑ About Biogen ( Memento of the original from April 2, 2015 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , global website biogen.com, accessed March 23, 2015 
3. ↑ ^{a b} Annual Report 2015 / Form 10-K ( Memento of the original dated February 11, 2016 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , accessed February 25, 2016  
4. ↑ ^{a b c} Biogen: BIOGEN REPORTS FULL YEAR 2019REVENUES OF $ 14.4BILLION . January 30, 2020. Accessed January 31, 2020.
5. ↑ ^{a b} The new Biogen ( Memento of the original from April 2, 2015 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , global website biogen.com, accessed February 25, 2016 
6. ↑ Therapies ( Memento of the original from February 25, 2016 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , German website biogen.de, accessed on February 25, 2016  
7. ↑ application areas , German site biogen.de, accessed on February 25, 2016
8. ↑ Contact , global website biogen.com, accessed February 25, 2016
9. ↑ Product Pipeline , global website biogen.com, accessed February 25, 2016
10. ↑ Imprint. Retrieved February 1, 2019 . 
11. ↑ Biogen and Sobi Announce European Medicines Agency Validates ALPROLIX® (rFIXFc) Marketing Authorization Application ( Memento of the original from February 25, 2016 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , Biogen PM of June 26, 2015, accessed February 25, 2016 
12. ↑ Alprolix specialist information (PDFB), specialist information service, accessed on July 13, 2018
13. ↑ www.avonex.de , accessed on February 25, 2016
14. ↑ Etanercept-Similar: On the market from February 15, Ärztezeitung from February 15, 2016, accessed on March 22, 2016
15. ↑ Benepali competes with Enbrel , Deutsche Apotheker Zeitung of February 16, 2016, accessed on March 22, 2016
16. ↑ Sobi and Biogen's ELOCTA® (rFVIIIFc) Approved in Europe for the Treatment of Haemophilia A ( Memento of the original from February 25, 2016 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. , Biogen PM of November 24, 2015, accessed February 25, 2016 
17. ↑ www.fampyra.de , accessed on February 25, 2016
18. ↑ FLIXABI®, Biogen's Infliximab Biosimilar Referencing Remicade®, Approved in the European Union ( Memento of the original from May 31, 2016 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , Biogen PM of May 30, 2016, accessed May 31, 2016 
19. ↑ Fumaderm ^® initial / Fumaderm ^® specialist information (PDF; 57 kB), specialist information service, accessed on February 25, 2016
20. ↑ PLEGRIDY ™ (Peginterferon beta-1a) Approved in the European Union for the Treatment of Multiple Sclerosis , PM Biogen Idec of July 23, 2014, accessed on February 25, 2016 (from www.businesswire.com)
21. ↑ Office of the Commissioner: FDA approves first drug for spinal muscular atrophy. March 18, 2019, accessed June 4, 2019 . 
22. ↑ Anonymous: Spinraza. September 17, 2018, accessed June 4, 2019 . 
23. ↑ SPINRAZA ™ (nusinersen) Approved in US to Treat Broad Range of Patients with Spinal Muscular Atrophy. Retrieved June 4, 2019 . 
24. ↑ Summary of the European public assessment report (EPAR) for Tecfidera , EPAR (only available in English), source: EMA, accessed on February 25, 2016
25. ↑ ^{a b} Fumaric acid ester: PML in psoriasis treatment , Deutsches Ärzteblatt from April 26, 2013, accessed on February 25, 2016
26. ↑ Tecfidera ^® (Dimethyl Fumarate) Approved in the European Union as a First-Line Oral Treatment for Multiple Sclerosis , PM from BiogenIdec dated February 4, 2014, accessed on February 25, 2016 (via www.businesswire.com)
27. ↑ Summary of the European public assessment report (EPAR) for Tysabri , EPAR (only available in English), source: EMA, accessed on February 25, 2016
28. ↑ www.tysabri.de , accessed on February 25, 2016
29. ↑ MabThera ^® specialist information (PDF; 349 kB), specialist information service, accessed on February 25, 2016
30. ↑ FDA approves Gazyva for chronic lymphocytic leukemia , PM FDA dated November 1, 2013, accessed March 21, 2016
31. ↑ Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for ZINBRYTA® (daclizumab) for Relapsing Multiple Sclerosis , Biogen PM, March 2, 2019, accessed March 22, 2019
32. ↑ Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer's Disease , Biogen PM, March 21, 2019, accessed March 22, 2019
33. ↑ Biogen's Alzheimer's Setback Destroys $ 17 Billion Market Value , Handelsblatt March 21, 2019, accessed March 22, 2019
34. ↑ Biogen Plans Regulatory Filing for Aducanumab in Alzheimer's Disease Based on New Analysis of Larger Dataset from Phase 3 Studies ; Biogen press release of October 22, 2019, accessed October 22, 2019
35. ↑ Biosimilars ( Memento of the original from March 15, 2016 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. global website biogen.com; accessed on March 16, 2016