“Today`s agreement with Pfizer is one of many steps we are taking to rapidly establish a sustainable presence in infectious disease R&D and combine our deep understanding of the immune system for the treatment of diseases with the cutting-edge technologies and significant infrastructure we have built over the years to develop immunotherapy treatments,” said Professor Ugur Sahin, Co-founder and CEO of BioNTech. “A significant presence in the field of infectious diseases supports our goal of building a global immunotherapy company that offers more effective and accurate immune-mediated approaches for the prevention and treatment of serious diseases such as influenza prevention and cancer treatment.” Basel, 21. Novartis, Oct. 2021 /PRNewswire/ — Novartis today announced the signing of an initial agreement to leverage its production capacity and ability to respond to the COVID-19 pandemic by expanding its support for the bottling and completion of Pfizer-BioNTech`s COVID-19 vaccine. Novartis will use its sterile production facilities at novartis` technical operations in Ljubljana, Slovenia, to fill at least 24 million cans in 2022. Under the terms of the new initial agreement, Novartis plans to take BioNTech`s bulk mRNA compound and fill it in vials under sterile conditions to return it to BioNTech for distribution. Subject to a final agreement, Novartis plans to relocate the stone manufacturing process to the Ljubljana site to begin bottling and completion in the first half of 2022. The Ljubljana plant is a state-of-the-art aseptic bottling plant that manufactures and supplies a wide range of aseptic products for Sandoz, a division of Novartis. This press release contains “forward-looking statements” by BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but are not limited to, statements regarding: BioNTech`s efforts to combat COVID-19; the timing of the start of clinical trials with BNT162 and the expected publication of data from those clinical trials; the timing of any authorisations or authorisations for emergency uses; the ability to enter into additional supply agreements with other jurisdictions or with the COVAX facility; the potential safety and efficacy of BNT162; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; and BioNTech`s ability to provide volumes of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. All forward-looking statements contained in this press release are based on BioNTech`s current expectations and beliefs regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements.
These risks and uncertainties include, but are not limited to: competition to develop a COVID-19 vaccine; the ability to achieve comparable clinical outcomes in larger and more diverse clinical trials; the ability to efficiently increase our production capacity; and other possible difficulties. A discussion of these and other risks and uncertainties can be found in BioNTech`s Annual Report on Form 20-F filed with the SEC on March 31, 2020 and available on the SEC`s website at www.sec.gov. All information contained in this press release relates to the date of the press release, and BioNTech assumes no obligation to update such information except as required by law. This new agreement follows a first contract signed earlier this year. Novartis began bottling for BioNTech at its Stein site in Switzerland in June after the European Union`s EMA approved the bottling and finishing plant. Under the terms of the agreement, BioNTech and Pfizer will jointly conduct research and development to advance mRNA-based influenza vaccines. Pfizer will assume full responsibility for the continued clinical development and commercialization of mRNA-based influenza vaccines after BioNTech completes a first clinical trial in humans. Novartis continues to offer its world-class capabilities to other companies to undertake manufacturing activities, including a variety of technologies such as mRNA production and others. Details will be disclosed when we make certain arrangements.
A more detailed description of the risks and uncertainties can be found in Pfizer`s Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent reports on Form 10-Q, including the sections entitled “Risk Factors” and “Forward-Looking Information and Factors That Could Affect Future Results” and subsequent reports on Form 8-K. all of which have been filed with the Securities and Exchange Commission of United States and are available at www.sec.gov and www.pfizer.com available. Pfizer and BioNTech are not the first pharmaceutical giants to make their way into Africa. In March, Johnson & Johnson announced an agreement with its manufacturing partner in South Africa, Aspen Pharmacare, to manufacture its vaccine at a port Elizabeth plant. The deal would help J&J deliver up to 400 million doses of its single-injection vaccine to the 55 member states of the African Union by 2022. This press release contains “forward-looking statements” by BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but are not limited to, BioNTech`s efforts to combat COVID-19, bioNTech and Pfizer`s ability to jointly develop and commercialize a COVID-19 vaccine, BioNTech`s and Pfizer`s ability to expand its production capacity, BioNTech`s potential COVID-19 mRNA vaccine, BNT162, an agreement for the joint development and commercialization of BNT162 by Pfizer and BioNTech, including the potential benefit and expected timing of a Phase 1 study on BNT162. All forward-looking statements contained in this press release are based on BioNTech`s current expectations and beliefs regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements.
These risks and uncertainties include: competition for a Covid-19 vaccine and potential difficulties. A discussion of these and other risks and uncertainties can be found in the “Risk Factors” and “Management Discussion and Analysis of Financial Condition and Results of Operations” section of BioNTech`s Annual Report on Form 20-F filed with the SEC on March 31, 2020 and filed with the SEC and available on the SEC`s website under www.sec.gov. All information contained in this press release relates to the date of the press release, and BioNTech assumes no obligation to update such information except as required by law. Under the terms of the agreement, Pfizer will pay BioNTech $185 million in upfront payments, including a $72 million cash payment and a $113 million equity investment. BioNTech is eligible for future milestone payments of up to $563 million, for a total potential consideration of $748 million. Pfizer and BioNTech will share development costs equally. Initially, Pfizer will fund 100% of the development costs, and BioNTech will reimburse Pfizer for its 50% share of those costs when the vaccine is commercialized. DisclaimerThis media update contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential”, “may”, “will”, “plan”, “may”, “could”, “expect”, “anticipate”, “look to the future”, “believe”, “required”, “under review”, “pipeline”, “introduction” or similar terms or by express or implied discussions about our agreement to manufacture Pfizer-BioNTech`s COVID-19 vaccine; or with respect to potential future revenues from the contract manufacturing agreement with BioNTech for Pfizer-BioNTech`s COVID-19 vaccine.
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