BIONTECH SE 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 risks associated with preclinical and clinical data (including the in vitro and Phase 3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations upon commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S.) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's ultra-low temperature formulation and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments. 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 https://www.globenewswire.com/Tracker?data=1_rjh1bjXWXTa0__FS4HAgCjIgJjj1juYB5fnhHLdhW4c9nBOSR2cVxobX5Go0h2wF78pviO_43SFTDCY2TquQ== www.sec.gov and https://www.globenewswire.com/Tracker?data=1_rjh1bjXWXTa0__FS4HAhvGueVC8CrFMD8YQSIcfR07CXwGD5MtdYb_Xx_s2pbvAJfVqA6ODy8X2S6CH7rYEQ== www.pfizer.com. About BioNTech Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology 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. 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. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit https://www.globenewswire.com/Tracker?data=1_rjh1bjXWXTa0__FS4HArBNJ1WBV6Hn8laLmDs_oEMw2_On9Y0kUpxBD-NIDJG7vCNBIzaDbgaAmPgkbeIx0Q== www.BioNTech.de. BioNTech Forward-looking Statements This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer regarding a COVID-19 vaccine; the ability of BNT162b2 to prevent COVID-19 caused by new virus variants; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan for BNT162b2 (COMIRNATY(R) ), including our estimated product shelf life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimate for 2021 and beyond as well as the timing and expectations of manufacturing capacities of the manufacturing network; discussions with government, regulatory authorities and partners to address future vaccine demand. 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. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, which is available on the SEC's website at www.sec.gov. 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 Contacts: Media Relations Andrew Widger +44 1737 330909 https://www.globenewswire.com/Tracker?data=sfp_rm27kgEM8_qUg875WdacgCS47m-UJ7ZIXBrgQUdW0L8ULUzoUKys9hErSHiwV6lEdtn7k2isuF6qir4sHRDre3pmjwzzU6HRxd0V4NtZQ1grkCnGsM5u6KE6o5wt Andrew.Widger@Pfizer.com Investor Relations Chuck Triano +1 (212) 733-3901 https://www.globenewswire.com/Tracker?data=01rMfWI1b1fDoVkwRBm0YkN7NiQ8qNDN09lpUzvx0H_X2l-PFUh4Aew1XAYlVXLRr9Jvf0HqJDPlie4OvOR6BOXKEK5ccepLRij2mYXygmDphVFNTPhKPgXuggghpzJc Charles.E.Triano@Pfizer.com BioNTech Contacts: Media Relations Jasmina Alatovic +49 (0) 6131 9084-1513 https://www.globenewswire.com/Tracker?data=Q-B8Pcdk_FSFr9lvMCw6JYeWUd48hdgRt_bKN0zK9BCfM-dzw6wFPwxMJ1-hUEmdWPjrcsIRiNRjaTN5iDX0_b4f6XFupv04kIXjtzbfoxM= Media@biontech.de Investor Relations Sylke Maas, Ph.D. +49 (0) 6131 9084 1074 https://www.globenewswire.com/Tracker?data=3FbMCDVy0cLcpq3ZpSO5FgVdeeBWXXR5es7jdTjQB-tZKsr8BLkH6b_40e1a9wNXbxQvx3K8dm5AnxMQ9nDOliUeDE_Bv8_u3YS1MvfJnzM= Investors@biontech.de
(END) Dow Jones Newswires
February 17, 2021 04:00 ET (09:00 GMT)
