BioNTech

BioNTech SE (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.

BioNTech SE
TypePublic (Societas Europaea)
NASDAQ: BNTX
ISINUS09075V1026
IndustryBiotechnology
Founded2008 (2008)
Founder
Headquarters
Mainz, Rhineland-Palatinate, Germany
Number of locations
8 (2020)
Area served
Worldwide
Key people
ProductsBNT162b2
ServicesImmunotherapy
Revenue €121.5 million (2019)
−181,518,000 euro (2019) 
−179,172,000 euro (2019) 
Total assets €797.7 million (2019)
Total equity €232.3 million (2019)
Number of employees
 1,323 (2019)
Websitebiontech.de
Footnotes / references
SEC report[1]

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

Foundation (2008–2013)

BioNTech was founded in 2008 based on research by Uğur Şahin, Özlem Türeci,[9] and Christoph Huber,[10] 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)

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)

Since 10 October 2019, BioNTech, with its newly founded North American headquarters 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

BioNTech's founding place and global headquarters is Mainz, Germany. The company runs multiple sites in the city. Further research locations are in San Diego and Cambridge (Mass.), the latter of which 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

In December 2019, BioNTech received €50 million loan, to finance the development of its patient-specific immunotherapies for the treatment of cancer and other serious diseases, 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]

June 2020, BioNTech secures a €100 million loan, from the European Investment Bank, to finance the clinical trials of the vaccine.[23][24]

On 15 September 2020, the German Federal Ministry of Education and Research (BMBF) awarded a €375 million grant to BioNTech, to accelerate the development of the vaccine.[25]

Vaccine development
See also: Pfizer–BioNTech COVID-19 vaccine and COVID-19 vaccine § Clinical trials started in 2020
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.[26] The company is working to develop the Pfizer–BioNTech COVID-19 vaccine with Pfizer[27] and Fosun.[28][29]

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.[30]

Vaccine distribution

July 2020, BioNTech and Manhattan-based Pfizer signed contracts to supply 120 million doses for Japan,[31] 100 million doses for the United States, at $19.50[32] and 40 million doses for the United Kingdom,[33][34] if proven effective, safe, and licensed.

On 5 August 2020, Canada pre-ordered 20 million doses.[35]

September 2020, Germany privately orders 30 million dosses, outside the collective EU purchasing scheme.[36]

On 5 November 2020, Australia pre-ordered 10 million doses.[37]

On 9 November 2020, BioNTech-Pfizer release a positive interim analysis of a Phase III clinical trial in the United States.

On 10 November 2020, the BioNTech-Pfizer partners applied for an emergency use authorization (EUA) with the FDA, which was reviewed by mid-December.[38][39] 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.".[40]

On 11 Nov 2020, the European Union pre-ordered 300 million doses, at an initial price of €12, per dose (For comparison this price agreed by the EU, for alternitive vaccines were: Oxford/AstraZeneca: €1.78; Johnson & Johnson: €8.50; Sanofi/GSK: €7.56; CureVac: €10; but Moderna's €18.)[41][42] 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.[43]

November 2020, Israel orders 8 million doses, at $23.50[44][45]

In November, Pfizer submitted an EUA application in Canada.[46]

On 2 December 2020, the United Kingdom granted conditional temporary authorization (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][47]

December 2020, BNT162b2 was under evaluation, for EUA status in several other countries.[48]

On 15 December 2020, Fosun Pharma agrees a deal to deliver 100 million doses to China.[49] With Hong Kong securing 7.5 million doses.

On 21 December 2020, The European Medicines Agency (EMA) authorized one-year conditional use of the BioNTech/Pfizer vaccine in the European Union . Emer Cooke, director of the EMA, stated that the benefits of the vaccine far outweigh the potential risks.

On 26 December 2020, Following the authorization, initial mass vaccination against coronavirus commenced in Hungary and Slovakia.[50]

On 8 January 2021, the European Union orders an additional 200 million doses of the vaccine, with an option for 100 million more.[51]

See also

References
  1. 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. "Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine" (PDF). Government of the United Kingdom. 2 December 2020. Retrieved 2 December 2020.
  4. "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
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  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.
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