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BioNTech

Coordinates:49°59′16″N8°16′17″E/ 49.9878°N 8.2713°E/49.9878; 8.2713
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BioNTech SE
Company typePublic
Nasdaq:BNTX
ISINUS09075V1026
IndustryBiotechnology
Founded2008;16 years ago(2008)
Founders
Headquarters
Mainz
,
Germany
Number of locations
8 (2022)
Area served
Worldwide
Key people
ProductsBNT162b2
ServicesImmunotherapy
RevenueDecrease€3.819billion (2023)
Decrease€690.4 million (2023)
Decrease€930.3 million (2023)
Total assetsDecrease€23.01 billion (2023)
Total equityIncrease€20.25 billion (2023)
Number of employees
Increase6,133 (2023)
Websitebiontech.com
Footnotes / references
Biontech FY 2023 report[1]

BioNTech SE(/biːˈɒntɛk/bee-ON-tek;or/baɪˈɒntɛk/bye-ON-tek[2]short forBiopharmaceutical New Technologies) is a Germanbiotechnologycompany based inMainzthat develops and manufactures activeimmunotherapiesfor patient-specific approaches to the treatment of diseases. It developspharmaceuticalcandidates based onmessenger ribonucleic acid(mRNA) for use as individualizedcancer immunotherapies,asvaccinesagainst infectious diseases and asprotein replacement therapiesforrare diseases,and also engineeredcell therapy,novelantibodiesandsmall moleculeimmunomodulatorsas treatment options for cancer.

The company has developed anmRNA-based human therapeuticfor intravenous administration to bring individualized mRNA-based cancer immunotherapy toclinical trialsand to establish its own manufacturing process.[3]

In 2020, BioNTech, partnering withPfizerfor testing and logistics, developed theRNA vaccineBNT162b2for preventingCOVID-19infections, which at the time offered a 91% efficacy[4]in preventing confirmed COVID-19 occurring at least 7 days after the second dose of vaccine.[5]On 2 December 2020, temporaryHMRauthorization was granted by the United Kingdom government for BNT162b2 vaccinations within theUnited Kingdom.[6][7]It was the first mRNA vaccine ever authorized. Some days later the vaccine also received an emergency approval in theUnited States,[8]Canada[9]andSwitzerland.[10]On 21 December 2020, theEuropean Commissionapproved BioNTech/Pfizer's coronavirus vaccine in accordance with the positive recommendation of theEuropean Medicines Agency(EMA).[11]In August 2021, thanks to a meteoric rise in its share price, BioNTech’smarket capitalizationbriefly exceeded US$100 billion, making it among the most valuable companies in Germany.[12]

History

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Foundation (2008–2013)

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BioNTech was founded in 2008 based on research byUğur Şahin,Özlem Türeci,[13]and Christoph Huber,[14]with a seed investment of €150 million fromMIG Capital,a Munich-basedventure capital firm,and AT Impf, an investment vehicle under control of the singlefamily officeof German billionaire twin brothers,AndreasandThomas Strüngmann.[15][16]The company's activities focus on the development and production of technologies and drugs for individualized cancerimmunotherapy.[3]In 2009, the acquisition of EUFETS and JPT Peptide Technologies took place.[17][18]Hungarian biochemistKatalin Karikó,whose work on mRNA whilst working at theUniversity of Pennsylvaniaunderpinned the development of Pfizer–BioNTech COVID-19 vaccine[19](and who later shared the 2023Nobel Prize in Physiology or Medicine,[20]) joined BioNTech as a senior vice president in 2013.[21]

Expansion (2014–2019)

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Between 2014 and 2018, many research results on mRNA mechanisms were published by BioNTech.[22]Collaborationsand commercialization programs were concluded with various companies andscientific institutionsstarting in 2015.[23]During this period, BioNTech filed severalpatent applicationsand developed a multi-layered strategy to protect its intellectual property in the varioustechnology platformsand their application in the treatment of cancer and other serious diseases.[citation needed]

In August 2018, the company entered into a multi-year research and development (R&D) collaboration with the US companyPfizer, Inc.to develop mRNA-based vaccines for prevention of influenza. Under the terms of the agreement, following BioNTech's completion of a first-in-human clinical study, Pfizer would assume sole responsibility for further clinical development and commercialization of mRNA-based flu vaccines.[24]

In January 2019,Sanofiinvested€80million in BioNTech and extended the mRNA cancer research collaboration between the two companies; Sanofi previously paidUS$60million upfront for the rights to five discovery-stage immunotherapies of BioNTech in 2015.[25]In July 2019,Fidelity Management & Research Companyled a Series B investment round totalling $325 million, with additional investments from Redmile Group, Invus,Mirae Asset Financial Group,Platinum Asset Management,Jebsen Capital, Steam Athena Capital, BioVeda China Fund and the Struengmann Family Office.[26][27]In September 2019, BioNTech received a capital contribution ofUS$55million from theBill & Melinda Gates Foundation,with the option of doubling that investment amount at a later date.[28]

Nasdaq IPO (2019) to COVID-19

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Since 10 October 2019, BioNTech, with its newly founded North American headquarters inCambridge,Massachusetts, has been publicly traded asAmerican Depository Shares(ADS) on theNASDAQ Global Select Marketunder the ticker symbol, BNTX.[29]BioNTech was able to generate total gross proceeds of 150 million dollars from theIPO.[30]

In 2021, BioNTech announced it would open its Asia headquarters in Singapore, and also open a vaccine manufacturing plant there, with support from theSingapore Economic Development Board.[31]The Singapore factory is expected to be operational by 2023 and produce hundreds of millions of doses of mRNA vaccines per year.[32]A collaboration withFosun Pharmais planned to add a facility inChinato produce a billion doses per year for China,Macau,Hong Kong,andTaiwan,though as of August 2021, the PRC had not approved any foreign-developed COVID-19 vaccines.[32]In July 2023, BioNTech acquired the British startup Instadeep for£562million ($682million) in order to expand its activities in the area ofartificial intelligencefor drug discovery, design and development.[33][34]

Corporate affairs

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Locations

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BioNTech is located in Germany
Mainz
Mainz
Idar-Oberstein
Idar-Oberstein
Martinsried
Martinsried
Neuried
Neuried
Berlin
Berlin
Marburg
Marburg
class=notpageimage|
Locations of BioNTech in Germany. The other two are in the United States.

BioNTech's founding place and global headquarters isMainz,Germany, where the COVID-19 vaccine was created. The company runs multiple sites in the country. Further research locations are inSan DiegoandCambridge, Massachusetts,the latter of which also serves as the North American headquarters.
Additionally the company ownsGMP-certifiedproduction facilities inIdar-Oberstein,Martinsried,Neuried, Bavaria,andBerlin.In November 2020, the company acquired facilities fromNovartisinMarburgto ramp up its vaccine production.[35][36]

Financing

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In December 2019, BioNTech received a €50 million loan, to finance the development of its patient-specific immunotherapies for the treatment of cancer and other serious diseases, from theEuropean Investment Bank(EIB) as part of theEuropean Commission Investment Plan for Europe.[37]

The EIB then signed a €100 million loan in June 2020, after an accelerated approval (two months for a process that usually takes more than a year). This financing helped BioNTech's vaccine trials and manufacturing. The EIB loan is part of the InnovFin Corporate Research Equity programme and the European Fund for Strategic Investments. This programme supports "innovative and higher-risk projects" backed by the European Investment Bank with a guarantee from the European Union budget.[38][39][40][41]On 17 March 2020, BioNTech received a $135 million investment fromFosun Pharmain exchange for 1.58 million shares in BioNTech and the future development and marketing rights of the mRNA vaccine BNT162b2 in China.[42]In June 2020, BioNTech received €250 million fromTemasek Holdings(Singapore) via the purchase of ordinary shares and 4 years convertible notes, but also from other investors through aprivate placementof mandatoryconvertible bonds.[43]On 15 September 2020, the GermanFederal Ministry of Education and Research(BMBF) awarded a €375 million grant to BioNTech, to accelerate the development of the COVID-19 vaccine.[44]

Board

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Board of BioNTech, as of March 2024, is made up ofUğur ŞahinCEO, Jens Holstein CFO, Sean Marett Chief Business and Commercial Officer, Sierk Poetting COO, Ryan Richardson Chief Strategy Officer, James Ryan Chief Legal Officer,Özlem TüreciChief Medical Officer.

Business activities

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Vaccine development

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See also:Pfizer–BioNTech COVID-19 vaccineandCOVID-19 vaccine § Clinical trials started in 2020
Pfizer–BioNTech COVID-19 vaccine

"Project Lightspeed", the project to develop a novel mRNA technology for a COVID-19 vaccine, began in mid-January 2020 just days after theSARS-Cov-2genetic sequencewas first made public.[45]The company is partnered on this project withPfizer[46]andFosun.[47][48]

The production of the vaccine was followed by clinical trials, the success of which was a prerequisite for the commencement of marketing. On 9 November 2020, BioNTech and Pfizer announced that 43,500 people in 6 countries had received a test vaccine against COVID-19 with 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.[49]

Vaccine distribution timeline

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In July 2020, BioNTech and pharmaceutical corporation Pfizer signed contracts to supply 120 million doses for Japan, 100 million doses for the United States at $19.50, and 40 million doses for the United Kingdom, if proven effective, safe, and licensed.[50][51][52][53]On 5 August 2020, Canada pre-ordered 20 million doses of the vaccine.[54]In September 2020, Germany privately ordered 30 million doses, outside the collective EU purchasing scheme.[55]On 5 November 2020, Australia pre-ordered 10 million doses.[56]On 9 November 2020, BioNTech-Pfizer released a positive interim analysis of aPhase III clinical trialin the United States. On 10 November 2020, BioNTech and Pfizer applied for anemergency use authorization(EUA) with theFDA,which was reviewed by mid-December.[57][58]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."[59]On 11 November 2020, theEuropean Unionpre-ordered 300 million doses, at an initial price of €12 per dose. 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.[60][61]Belgium's budget state secretaryEva De Bleeker[nl]accidentally revealed the vaccine purchase price-per-dose agreed by the EU with various companies, with Oxford-AstraZeneca at €1.78; Johnson & Johnson at $8.50, Sanofi-GSK at €7.56,CureVacat €10, andModernaat $18.[62]In the same month, Israel ordered 8 million doses at $23.50 a dose.[63][64]In the same month BioNTech-Pfizer submitted an EUA application in Canada.[65]On 2 December 2020, the United Kingdom granted conditional temporary authorization (under Regulation 174 of theHuman Medicines Regulations 2012) for BNT162b2,[6]becoming the first country to approve an mRNA vaccine and the firstWestern countryto approve a COVID-19 vaccine for national use.[7][66]In the same month, BNT162b2 was revealed to also be under evaluation for EUA status in several other countries.[67]On 15 December 2020, Fosun Pharma agreed a deal to deliver 100 million doses of the BioNTech-Pfizer vaccine to China,[68]with Hong Kong securing 7.5 million doses. On 21 December 2020, the European Medicines Agency (EMA) authorised a 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.[69]On 26 December 2020, following the authorisation, initial mass vaccination against coronavirus commenced inHungaryandSlovakia.[70]

On 8 January 2021, the European Union ordered an additional 200 million doses of the vaccine, with an option for 100 million more.[71]On 25 June 2021, theUS Food and Drug Administration (FDA)added a warning about the risk of rare heart inflammation (myocarditis) to the specifications of both Pfizer/BioNTech and Moderna vaccines. As of that date, there were already 138 millionUS citizenswho had been vaccinated twice with one of themRNA-based vaccines,according to theUS Centers for Disease Control and Prevention (CDC).[72][73]

Cancer immunotherapy

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In early 2023 BioNTech started a series of clinical trials in the United Kingdom for mRNA based immunotherapies targeting several types of cancer.[74]In November 2023, in an interview to German broadcasterZDF,BioNTech CEOUğur Şahinsaid the company expects amRNA-based therapeutic cancer vaccine approval by 2030.[75]

Sponsorship

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BioNTech, together with Pfizer, co-sponsored theAcademy Awards ceremonyin March 2022 as main sponsors.[76]

In thesponsorship,the pharmaceutical duo stated that the widespread use of their vaccines and booster shots has helped preventCovid19 diseasesand protect lives, and thefilm industryhas partnered topromotevaccines, mask use and other prevention strategies. BioNTech's spectacularmarketing promotionalsuccess in the2022 Oscars'sponsorship was its ability to appear ahead of its huge pharma partner Pfizer in the promotional duo'subiquitousroster. This was a significant achievement because by this time 'BioNTech' had been removed from the name of the vaccine in almost every language in the world, and their joint product was mostly referred to simply as 'Pfizer'.[77]

See also

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References

[edit]
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