BioNTech

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BioNTech SE
TypePublic (Societas Europaea)
NASDAQ: BNTX
(English depository receipts)
ISINUS09075V1026
IndustryBiotechnology
Founded2008; 13 years ago (2008)
Founder
Headquarters
Global HQ:
Mainz, Rhineland-Palatinate, Germany
North American HQ:
Cambridge, Massachusetts, United States
Number of locations
8 (2020)
Area served
Worldwide
Key people
ProductsBNT162b2
ServicesImmunotherapy
RevenueDecrease €121.5 million (2019)
Total assetsIncrease €797.7 million (2019)
Total equityIncrease €232.3 million (2019)
Number of employees
Increase 1,323 (2019)
Websitebiontech.de
Footnotes / references
SEC report[1]

BioNTech SE (/ˈbaɪɒntɛk/ BY-on-tek; short for Biopharmaceutical New Technologies) is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. It develops pharmaceutical candidates based on messenger ribonucleic acid (mRNA) for use as individualized cancer immunotherapies, as vaccines against infectious diseases and as protein replacement therapies for rare diseases, and also engineered cell therapy, novel antibodies and small molecule immunomodulators as treatment options for cancer.

The company has developed an mRNA-based human therapeutic for intravenous administration to bring individualized mRNA-based cancer immunotherapy to clinical trials and to establish its own manufacturing process.[1]

In 2020 BioNTech developed, in conjunction with Pfizer, the RNA vaccine BNT162b2 for preventing COVID-19 infections, which offers a 95% efficacy.[2] On 2 December 2020, temporary HMR authorization was granted by the United Kingdom government for BNT162b2 vaccinations within the UK.[3][4] It was the first mRNA vaccine ever authorized. Some days later the vaccine got also an emergency approval in the United States,[5] Canada,[6] and Switzerland.[7] On 21 December 2020, the European Commission approved BioNTech/Pfizer's coronavirus vaccine in accordance with the positive recommendation of the European Medicines Agency (EMA).[8]

History[edit]

Foundation (2008–2013)[edit]

BioNTech was founded in 2008 based on research by Uğur Şahin, Özlem Türeci,[9] and Christoph Huber,[10][citation needed] with a seed investment of €150 million.[11] The company's activities focus on the development and production of technologies and drugs for individualized cancer immunotherapy.[1] Andreas and Thomas Strüngmann, Michael Motschmann, and Helmut Jeggle were cofounders.[12] In 2009, the acquisition of EUFETS and JPT Peptide Technologies took place.[13][14] In 2013, Katalin Karikó joined BioNTech as a senior vice president [15].

Expansion (2014–2019)[edit]

Between 2014 and 2018, many research results on mRNA mechanisms were published by BioNTech.[16] Collaborations and commercialization programs were concluded with various companies and scientific institutions starting in 2015.[17] During this period, BioNTech filed several patent applications and developed a multi-layered strategy to protect its intellectual property in the various technology platforms and their application in the treatment of cancer and other serious diseases.

In September 2019, BioNTech received an equity investment of US$55 million from the Bill & Melinda Gates Foundation, with the option of doubling that investment amount at a later date.[18]

Nasdaq IPO (2019)[edit]

Since 10 October 2019, BioNTech, with its newly founded North American headquarter in Cambridge, Massachusetts, has been publicly traded as American Depository Shares (ADS) on the Nasdaq Global Select Market under the ticker symbol, BNTX.[19] BioNTech was able to generate total gross proceeds of 150 million dollars from the IPO.[20]

Locations[edit]

BioNTech's founding place and global headquarter is Mainz, Germany. The company runs multiple sites in the city. Further research locations are in San Diego and Cambridge (Mass.) with also serves as the North American headquarters.
Additionally the company owns GMP-certfified production facilities in Idar-Oberstein, Martinsried, Neuried and Berlin. In November 2020, the company acquired facilities from Novartis in Marburg to ramp up its vaccine production.

Investments and financing[edit]

In December 2019, BioNTech received €50 million in financing from the European Investment Bank as part of the European Commission Investment Plan for Europe.[21]

In June 2020, BioNTech received €250 million from Temasek Holdings (Singapore) via the purchase of ordinary shares and 4 years convertible notes, but also from other investors through a private placement of mandatory convertible bonds.[22] It also received EUR100 million from the European Investment Bank in debt financing.[23]

Vaccine development[edit]

See also: Tozinameran and COVID-19 vaccine § Clinical trials started in 2020
Tozinameran (Pfizer-BioNTech COVID-19 vaccine)

The project to develop a novel mRNA technology for a COVID-19 vaccine was called "Project Lightspeed", which started in mid-January 2020 just days after the SARS-Cov-2 genetic sequence was first made public.[24] The company is working to develop the tozinameran RNA vaccine with Pfizer[25] and Fosun.[26][27]

The production of the vaccine was followed by clinical trials, the success of which was a prerequisite for the commencement of marketing. On November 9, 2020, BioNTech and Pfizer announced that 43,500 people in 6 countries have got a test vaccine against COVID-19 and the clinical trials had more than 90 percent effectiveness.  On the basis of successful testing, they asked for the right to distribute vaccines in the United States, as well as in the European Union, the United Kingdom and Japan.[28]

Vaccine distribution[edit]

BioNTech and Pfizer signed contracts to supply 300 million doses of a SARS-CoV-2 vaccine for the European Union,[29] 120 million doses for Japan,[30] 100 million doses for the United States,[31] and 40 million doses for the United Kingdom,[32][33] if proven effective, safe, and licensed.

On 10 November 2020 following positive interim analysis of a Phase III clinical trial in the United States, the BioNTech-Pfizer partners applied for an EUA with the FDA, which is scheduled to review the application by mid-December.[34][35] The FDA released a document explaining that an EUA is "a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.".[36] In November, Pfizer submitted an EUA application in Canada.[37]

On 2 December 2020, the United Kingdom granted conditional temporary authorisation (under Regulation 174 of the Human Medicines Regulations 2012) for BNT162b2,[3] becoming the first country to approve an mRNA vaccine and the first Western country to approve a COVID-19 vaccine for national use.[4][38] BNT162b2 was under evaluation during December for emergency use authorization (EUA) status in several other countries.[39]

The European Medicines Agency (EMA) authorized one-year conditional use of the BioNTech/Pfizer vaccine in the European Union on 21 December 2020. Emer Cooke, director of the EMA, stated that the benefits of the vaccine far outweigh the potential risks. The price of a dose of BioNTech/Pfizer vaccine is EUR 12. (For comparison this costs more than four of its future five competitors: Oxford/AstraZeneca: EUR 1.78; Johnson & Johnson: EUR 8.50; Sanofi/GSK: EUR 7.56; CureVac: EUR10; but Moderna's vaccine is more expensive, costing EUR 18.)[40] Under the agreement, the vaccine-producing pair, BioNTech and Pfizer are subject to a tightened legal obligation to bring all the experience they have gained to the EMA for review.[41]

Following the authorization mass vaccination against coronavirus was started for the first time in Hungary and Slovakia in the European Union on 26 December 2020.[42]

See also[edit]

References[edit]

  1. ^ a b c BioNTech SE (9 September 2019), Form F-1, U.S. Securities and Exchange Commission, retrieved 23 September 2020
  2. ^ https://www.fda.gov/media/144245/download
  3. ^ a b "Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine" (PDF). Government of the United Kingdom. 2 December 2020. Retrieved 2 December 2020.
  4. ^ a b "UK medicines regulator gives approval for first UK COVID-19 vaccine". Government of the United Kingdom. 2 December 2020. Retrieved 2 December 2020.
  5. ^ Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions, retrieved 22 December 2020
  6. ^ Pfizer-BioNTech COVID-19 vaccine: What you should know, retrieved 22 December 2020
  7. ^ Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland, retrieved 22 December 2020
  8. ^ "Commission approves BioNTech/Pfizer vaccine". POLITICO. 21 December 2020. Retrieved 22 December 2020.
  9. ^ "BioNTech's founders: scientist couple in global spotlight". France 24. 13 November 2020. Retrieved 22 December 2020.
  10. ^ Ryan Browne (11 November 2020). "What you need to know about BioNTech — the European company behind Pfizer's Covid-19 vaccine". CNBC. Retrieved 7 December 2020.
  11. ^ "SEC Filing | BioNTech". investors.biontech.de. Retrieved 28 December 2020.
  12. ^ "BioNTech's founders: scientist couple in global spotlight". France24. 13 November 2020. Retrieved 7 December 2020.
  13. ^ Eufets Becomes BioNTech Innovative Manufacturing Services, BioNTech IMFS, 18 September 2017, retrieved 11 November 2020
  14. ^ "TheraCode to Acquire JPT Peptide Technologies". GenomeWeb. 11 May 2009. Retrieved 7 December 2020.
  15. ^ "Magyar kutató, hányatatott sorsú szabadalma is kellett a most bejelentett vakcinához | Forbes.hu". forbes.hu (in Hungarian). 9 November 2020. Retrieved 22 December 2020.
  16. ^ Kranz, Lena M.; Diken, Mustafa; Haas, Heinrich; Kreiter, Sebastian; Loquai, Carmen (16 June 2016), "Systemic RNA delivery to dendritic cells exploits antiviral defence for cancer immunotherapy", Nature, 534 (7607), pp. 396–401, Bibcode:2016Natur.534..396K, doi:10.1038/nature18300, ISSN 1476-4687, PMID 27281205, retrieved 11 November 2020
  17. ^ Nick Paul Taylor (21 September 2016). "Genentech lays $310M wager on BioNTech's mRNA cancer vaccine platform". FierceBiotech. Retrieved 7 December 2020.
  18. ^ "BioNTech Announces New Collaboration to Develop HIV and Tuberculosis Programs". BioNTech. 4 September 2019. Retrieved 27 December 2020.
  19. ^ BioNTech SE, Nasdaq, retrieved 12 November 2020
  20. ^ Spalding, Rebecca; Franklin, Joshua (9 October 2019). "Germany's BioNTech raises $150 million in smaller-than-planned U.S. IPO amid market volatility". Reuters. Retrieved 7 December 2020.
  21. ^ "European Investment Bank provides funding of €50 million to BioNTech as part of the Investment Plan for Europe". European Commission. 17 December 2019. Retrieved 21 November 2020.
  22. ^ Burger, Ludwig (29 June 2020). "Temasek-led investor group in $250 million vaccine bet on Germany's BioNTech". Reuters. Frankfurt. Retrieved 2 August 2020.
  23. ^ "Investment Plan for Europe: European Investment Bank to provide BioNTech with up to €100 million in debt financing for COVID-19 vaccine development and manufacturing". European Commission. 11 June 2020. Retrieved 21 November 2020.
  24. ^ "Aiming to address the global coronavirus pandemic: Project Lightspeed". BioNTech. 2020. Retrieved 13 December 2020.
  25. ^ Lovelace Jr., Berkeley (27 July 2020). "Pfizer and BioNTech began late-stage human trial for coronavirus vaccine Monday". CNBC. Retrieved 2 August 2020.
  26. ^ "BioNTech in China alliance with Fosun over coronavirus vaccine candidate". Reuters. Frankfurt. 15 March 2020. Retrieved 2 August 2020.
  27. ^ Burger, Ludwig (22 April 2020). "Germany approves trials of COVID-19 vaccine candidate". Reuters. Berlin. Retrieved 2 August 2020.
  28. ^ "Covid vaccine: First 'milestone' vaccine offers 90% protection". BBC News. 9 November 2020. Retrieved 22 December 2020.
  29. ^ "Coronavirus: EU buys 300m doses of BioNTech-Pfizer vaccine". BBC News. United Kingdom. 11 November 2020. Retrieved 12 November 2020.
  30. ^ Shakil, Ismail; Mishra, Manas (31 July 2020). "Pfizer, BioNTech to supply 120 million doses of coronavirus vaccine to Japan". Reuters. Bengaluru. Retrieved 3 August 2020.
  31. ^ Erman, Michael; Banerjee, Ankur (22 July 2020). "U.S. to pay Pfizer, BioNTech $1.95 billion for COVID-19 vaccine". Reuters. Retrieved 2 August 2020.
  32. ^ Gallagher, James (20 July 2020). "Coronavirus vaccine: UK government signs deals for 90 million doses". BBC News. Retrieved 2 August 2020.
  33. ^ Smout, Alistair (20 July 2020). "Britain secures 90 million possible COVID-19 vaccine doses from Pfizer/BioNTech, Valneva". Reuters. London. Retrieved 2 August 2020.
  34. ^ "Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate". U.S. Food and Drug Administration (FDA) (Press release). Retrieved 20 November 2020. This article incorporates text from this source, which is in the public domain.
  35. ^ Helen Branswell (20 November 2020). "Pfizer, BioNTech submit formal application to FDA to authorize Covid-19 vaccine". STAT. Retrieved 25 November 2020.
  36. ^ "Emergency Use Authorization for Vaccines Explained". U.S. Food and Drug Administration. 20 November 2020. Retrieved 20 November 2020. This article incorporates text from this source, which is in the public domain.
  37. ^ Katie Dangerfield (20 November 2020). "Pfizer files for emergency use of coronavirus vaccine in U.S. — what about in Canada?". Global News. Retrieved 25 November 2020.
  38. ^ Roberts, Michelle (2 December 2020). "Covid Pfizer vaccine approved for use next week in UK". BBC. Retrieved 2 December 2020.
  39. ^ Benjamin Mueller (2 December 2020). "U.K. Approves Pfizer coronavirus vaccine, a first in the West". The New York Times. Retrieved 2 December 2020.
  40. ^ "Belgian secretary of state accidentally reveals EU vaccine prices". POLITICO. 17 December 2020. Retrieved 22 December 2020.
  41. ^ "Az Európai Gyógyszerügynökség forgalmazásra ajánlja a Pfizer/BioNTech-vakcinát". koronavirus.gov.hu (in Hungarian). 21 December 2020. Retrieved 22 December 2020.
  42. ^ Binnie, Anita Komuves, Benoit Van Overstraeten, Isla (27 December 2020). "'Window of hope': Europe begins to launch COVID-19 vaccinations". Reuters. Retrieved 27 December 2020.

External links[edit]

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