+49 (0)6131 9084 1513 or +49 (0)151 1978 1385 Investor Relations ... et al. During the clinical development stage, BioNTech and its partners will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. “Combatting the COVID-19 pandemic will require unprecedented collaboration across the innovation ecosystem, with companies coming together to unite capabilities like never before,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. But Dr. Sahin’s pivot to Covid-19 in January scrambled the timetable. Companies will jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection Collaboration aims to accelerate global development of BNT162, leveraging expertise and resources of both companies Builds on 2018 agreement to jointly develop an mRNA-based influenza vaccine Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech… BioNTech and Pfizer will also work jointly to commercialize the vaccine worldwide (excluding China, which is already covered by BioNTech’s collaboration with Fosun Pharma) upon regulatory approval. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. Spoločnosti uzavreli dohodu o … Media RelationsAmy Rose (U.S.)+1 (212) 733-7410amy.rose@pfizer.com, Lisa O’Neill (UK)+44 7929339560 lisa.o'neill@pfizer.com, Investor RelationsRyan Crowe+1 (212) 733-8160ryan.crowe@pfizer.com, Media RelationsJasmina Alatovic Senior Manager Global External Communications+49 (0)6131 9084 1513 or +49 (0)151 1978 1385Media@biontech.de, Investor RelationsSylke Maas, Ph.D.VP Investor Relations & Business Strategy+49 (0)6131 9084 1074Investors@biontech.de, BioNTech SE The stunning results vaulted BioNTech and Pfizer to the front of the race to find a cure for a disease that has killed more than 1.2 million people worldwide. Pfizer and BioNTech will share development costs equally. lisa.o'[email protected] NEW YORK, USA a MAINZ, Nemecko, 17. marec 2020 – Spoločnosti Pfizer Inc. a BioNTech SE dnes oznámili, že podpísali dohodu ohľadom spoločného vývoja a distribúcie (s výnimkou Číny) prípadnej vakcíny proti koronavírusu na báze mRNA určenej na prevenciu infekcie COVID-19. [email protected] The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. Pfizer Disclosure NoticeThe information contained in this release is as of April 9, 2020. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. As the epidemic raged in China—making it a good place to hold vaccine trials—he struck a deal with Shanghai Fosun Pharmaceutical Co., Ltd. to test candidates there. Initially, Pfizer will fund 100 percent of the development costs, and BioNTech will repay Pfizer its 50 percent share of these costs during the commercialization of the vaccine. These risks and uncertainties include, but are not limited to: competition to create a vaccine for Covid-19 and potential difficulties. During the clinical development stage, BioNTech and its partners will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. Pfizer and BioNTech are readying “Mission Possible,” a branded content film created in collaboration with National Geographic, for debut on March 11. BioNTech is eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million. [email protected]. Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer, infectious diseases and rare diseases. Pfizer and BioNTech to jointly develop COVID-19 vaccine, initially in the United States and Europe, and scale-up manufacturing capacity to support global supply Potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Thirty million doses expected to be delivered in 2020 and 2021, subject to regulatory approval or authorization Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020 and manufacture globally up to 100 million doses … In addition to its multiple mRNA formats, BioNTech has developed three different lipid delivery formulations. Sylke Maas, Ph.D. Its broad portfolio of product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. The vaccine and other medication. US company Moderna has also developed an RNA vaccine, which has also been approved for use in the United States. handling or other issues:service@biontech.de, For any other questions, please Germany, For questions on logistics, Media Relations “I am proud of Pfizer’s collaboration with BioNTech and have every confidence in our ability to harness the power of science – together – to bring forth a potential vaccine that the world needs as quickly as possible.”. The manufacturer’s information for healthcare professionals contains no information on interactions with any other medication (since this has not been studied). CAS PubMed Google Scholar ET. England can justly claim the credit for inventing the T20 format in cricket. Its broad portfolio of product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. BioNTech Contacts: The Pfizer-BioNTech COVID-19 vaccine is administered as an intramuscular injection on day 0 and again on day 21. Ryan Crowe All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. These forward-looking statements may include, but may not be limited to, BioNTech’s efforts to combat COVID-19, the ability of BioNTech and Pfizer to co-develop and co-commercialize a vaccine for COVID-19, the ability of BioNTech and Pfizer to develop manufacturing capacity, BioNTech’s potential COVID-19 mRNA vaccine, BNT162, an agreement regarding the co-development and co-commercialization by Pfizer and BioNTech of BNT162, including its potential benefits and the expected timing of a Phase 1 trial of BNT162. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network. The Pfizer-BioNTech vaccine received authorization for use by the UK regulator on 2 December. +1 (212) 733-8160 For more information, please visit www.BioNTech.de. [email protected] The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. Thirty million doses expected to be delivered in 2020 and 2021, subject to regulatory approval or authorization Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020 and manufacture globally up to 100 million doses … MAINZ, Germany, and NEW YORK, April 09, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), and Pfizer Inc. (NYSE: PFE) today disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program, previously announced on March 17, 2020. Pfizer and BioNTech will share development costs equally. BioNTech Forward-looking statementsThis press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. Jul. [email protected] +44 7929339560 Jasmina Alatovic For more information, please visit www.BioNTech.de. Under the terms of the agreement, Pfizer will pay BioNTech $185 million in upfront payments, including a cash payment of $72 million and an equity investment of $113 million. Investor Relations BioNTech is eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million. Can it claim the Covid-19 vaccine world cup too, as Gavin Williamson, the British education secretary, has declared that his country has better science than Europe or the US? We routinely post information that may be important to investors on our website at www.Pfizer.com. BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance. “Combatting the COVID-19 pandemic will require unprecedented collaboration across the innovation ecosystem, with companies coming together to unite capabilities like never before,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. 55131 Mainz The Pfizer BioNTech coronavirus vaccine produces as good results in the “real world” as have been previously documented in randomised trials. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network. 2020;160:223-232. EMA has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age.EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine … All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. Pfizer and BioNTech to jointly develop COVID-19 vaccine, initially in the United States and Europe, and scale-up manufacturing capacity to support global supply Potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and … We routinely post information that may be important to investors on our website at www.Pfizer.com. In Europe, Pfizer and BioNTech initially shipped vials of five-vaccine doses, but because of a precautionary practice known as overfilling, the vials contained enough extra liquid for a sixth dose. It has also been approved in other countries, including the US, Canada and in the European Union. Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when any biologics license applications may be filed in any jurisdictions for any potential vaccine candidates under the collaboration; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such vaccine candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities regarding any such vaccine candidates and uncertainties regarding the commercial impact of any such recommendations; and competitive developments. This webinar provide an overview and education of the Pfizer-BioNTech COVID19 vaccine. BioNTech and Pfizer’s influenza jab was due to enter human trials in 2020. NACCHO invites local health department leadership and staff to join the Pfizer-BioNTech COVID-19 Vaccine Training & Education webinar on Tuesday, January 12, 3:00-4:00 pm ET.. and BioNTech for the purchase of up to 1.8 billion doses of their COVID-19 vaccines to be delivered in 2022 and 2023, an EU official told Reuters. The full benefit from the vaccine occurs 2 weeks after the second injection. He claimed that the speed with which British regulators appraised trial evidence on the Pfizer-BioNTech … BioNTech and Pfizer announce regulatory approval from … In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Sorry, you need to enable JavaScript to visit this website. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. The joint vaccine, produced by American pharmaceutical giant Pfizer and German biotech firm BioNTech, had recently claimed to be 94 per cent effective in protecting people over 65 years old from COVID-19, with trials suggesting it works equally well in people of all ages, races and ethnicities. About Pfizer: Breakthroughs That Change Patients’ Lives. “We have already started working with Pfizer on our COVID-19 vaccine and are pleased to announce these further details of our ongoing collaboration, which reflects both companies’ strong commitment to move quickly to bring a safe and efficacious vaccine to patients worldwide,” says Co-Founder and CEO of BioNTech, Ugur Sahin, M.D. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. The products discussed herein may have different labeling in different countries. ... April 9, 2021, 7:09 p.m. The information contained in this release is as of April 9, 2020. “We have already started working with Pfizer on our COVID-19 vaccine and are pleased to announce these further details of our ongoing collaboration, which reflects both companies’ strong commitment to move quickly to bring a safe and efficacious vaccine to patients worldwide,” says Co-Founder and CEO of BioNTech, Ugur Sahin, M.D. Initially, Pfizer will fund 100 percent of the development costs, and BioNTech will repay Pfizer its 50 percent share of these costs during the commercialization of the vaccine. use our contact form atconnect.biontech.de, We aspire to utilize the full potential of the immune system to fight cancer and infectious diseases, Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development, Our vision: individualize cancer medicine, How we approach individualized cancer medicine, Why mRNA represents a disruptive new drug class, Beyond mRNA: Expanding therapeutics with our antibody discovery engines, Explore our individualized immunotherapy pipeline, Tour our platforms that produce individually-tailored therapeutics, Our Mission: broaden the therapeutic universe to benefit patients. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. For more than 150 years, we have worked to make a difference for all who rely on us. View source version on businesswire.com: https://www.businesswire.com/news/home/20200409005405/en/, Pfizer Contacts ET This vaccine is not a live virus vaccine and can be given to immunocompromised patients, including patients on immunosuppressant … This press release features multimedia. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. “I am proud of Pfizer’s collaboration with BioNTech and have every confidence in our ability to harness the power of science – together – to bring forth a potential vaccine that the world needs as quickly as possible.”. For a discussion of these and other risks and uncertainties, see the section entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020 which has been filed with the SEC and is available on the SEC’s website at www.sec.gov. +1 (212) 733-7410 ). BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Eli Lilly and Company, Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer. This page summarises and signposts to information about interactions with the Pfizer-BioNTech COVID-19 vaccine. VP Investor Relations & Business Strategy BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. Copyright © 2002-2021 Pfizer Inc. All rights reserved. The vaccine is currently authorized for emergency use in the United States for people aged 16 and up. The collaboration aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms, with the objective of ensuring rapid worldwide access to the vaccine, if approved. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. View the full release here: https://www.businesswire.com/news/home/20200409005405/en/. Pfizer Inc and its German partner BioNTech SE on Friday asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 15. This information—including product information—is intended only for residents of the United States. Under the terms of the agreement, Pfizer will pay BioNTech $185 million in upfront payments, including a cash payment of $72 million and an equity investment of $113 million. Amy Rose (U.S.) BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Eli Lilly and Company, Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer. Baum, A. et al. German biotech BioNTech SE worked on cancer treatments, and was developing an influenza vaccine with Pfizer Inc., when its founder, Ugur Sahin, led the company’s pivot to the coronavirus in January. These forward-looking statements may include, but may not be limited to, BioNTech’s efforts to combat COVID-19, the ability of BioNTech and Pfizer to co-develop and co-commercialize a vaccine for COVID-19, the ability of BioNTech and Pfizer to develop manufacturing capacity, BioNTech’s potential COVID-19 mRNA vaccine, BNT162, an agreement regarding the co-development and co-commercialization by Pfizer and BioNTech of BNT162, including its potential benefits and the expected timing of a Phase 1 trial of BNT162. BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance. +49 (0)6131 9084 1074 The company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. These risks and uncertainties include, but are not limited to: competition to create a vaccine for Covid-19 and potential difficulties. BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), and Pfizer Inc. (NYSE: PFE) today disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program, previously announced on March 17, 2020.