Pfizer Advances Battled Against COVID-19 on Multiple Fronts

Pfizer Inc. (NYSE: PFE) recently announced important advances in the battle against the global COVID-19 pandemic.

As outlined in Pfizer’s five-point plan, the company has been collaborating across the healthcare innovation ecosystem ranging from pharmaceutical companies to biotech companies, from government agencies to academic institutions to address the COVID-19 global health care crisis. Researchers and scientists have been relentlessly working to develop an investigational antiviral compound to prevent coronavirus infection (COVID-19), as well as evaluating other therapies that have scientific potential to help infected patients.

“We are committed to making the impossible possible,” said Dr. Albert Bourla, Chairman and CEO. “In the spirit of the Five Point Plan that Pfizer issued, we are facing this public health challenge head on by collaborating with industry partners and academic institutions to develop potential novel approaches to prevent and treat COVID-19. Our researchers and scientists also have been exploring potential new uses of existing medicines in Pfizer’s portfolio to help infected patients globally. We are leaving no stone unturned as we explore every option to help provide society with a treatment or cure.”

• Anti-Viral Compound Screening

Pfizer confirmed a lead compound and analogues are potent inhibitors of the SARS-CoV-2 3C-like (3CL) protease, based on the results of initial screening assays. Preliminary data suggest the lead protease inhibitor shows antiviral activity against SARS-CoV-2. The company is also investing in materials that will accelerate a potential clinical study in the third quarter 2020, subject to positive completion of the pre-clinical confirmatory studies.
Applying Pfizer’s Long History in Vaccine Research Development Expertise to Finalize Our 

• Agreement with BioNTech

Pfizer Inc. and BioNTech SE have entered into a global collaboration agreement to co-develop BioNTech’s potential first-in-class, mRNA-based coronavirus vaccine for preventing COVID-19 infection. In March 2020, the companies began working together after releasing a letter of intent to collaborate. They will conduct clinical trials in the United States and Europe as early as April 2020, assuming regulatory clearance. The companies estimate that there is potential to supply vaccine doses by the end of 2020 subject to technical success and approval of regulatory authorities and then rapidly scale up to capacity to produce million doses in 2021. For the terms of the agreement, please see the press release page of Pfizer’s website.

• Analysis of Azithromycin as an Agent with Antiviral Activity

In an effort to share information that could benefit COVID-19 mitigation efforts, Pfizer researchers will publish a review in Clinical Pharmacology and Therapeutics. This open access review may serve to facilitate the use of azithromycin in future research on COVID-19. Azithromycin is not approved for the treatment of viral infections.

• Studying Pfizer’s Existing Medicines for Critical Patient Populations in Need

Pfizer is also in discussions with other institutions about additional studies including the Liverpool School of Tropical Medicine’s Respiratory Infection Clinical Research Group. Two new studies: SAFER study (SARS-CoV-2 Acquisition in Frontline Health Care Workers – Evaluation to Inform Response) and the FASTER study (Facilitating A SARS CoV-2 Test for Rapid triage) will help demonstrate whether patients infected with COVID-19 have a higher risk of also developing pneumococcal pneumonia. The SAFER study will enroll 100 healthcare workers at the Royal Liverpool Hospital while the FASTER study will recruit 400 patients from the infectious disease ward at the Royal Liverpool Hospital suspected of having coronavirus. Enrollment has already begun, and data are expected over the next few months. For more details about the study, please see clinicaltrials.gov.

“While this work can generally take years, we are working to find opportunities to save time wherever we can and work in parallel rather than in a linear capacity,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. “This pursuit requires a crucial multi-pronged approach with a deep collaboration and partnership across the health innovation ecosystem – from the academic community, industry partners, policymakers and regulatory bodies. We announced in March that we are collaborating with BioNTech to co-develop a potential first-in-class, mRNA-based COVID-19 vaccine. A public threat like coronavirus COVID-19 pushes each of us to urgently bring forward our resources and expertise to overcome this most challenging moment in the medical history of this century.”

The company will continue to share information from its portfolio and emerging candidates that could benefit the many companies and organizations who are working quickly to provide solutions to combat this unprecedented healthcare crisis.

• Pfizer, Inc.: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. 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. Every day, Pfizer colleagues work to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. 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. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. 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.

Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the companies have agreed to a letter of intent regarding the co-development and distribution (excluding China) of a potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection. The companies have executed a Material Transfer and Collaboration Agreement to enable the parties to immediately start working together.

The collaboration aims to accelerate development of BioNTech’s potential first-in-class COVID-19 mRNA vaccine program, BNT162, which is expected to enter clinical testing by the end of April 2020. The rapid advancement of this collaboration builds on the research and development collaboration into which Pfizer and BioNTech entered in 2018 to develop mRNA-based vaccines for prevention of influenza.

“We are proud that our ongoing, successful relationship with BioNTech gives our companies the resiliency to mobilize our collective resources with extraordinary speed in the face of this worldwide challenge,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. “We believe that by pairing Pfizer’s development, regulatory and commercial capabilities with BioNTech’s mRNA vaccine technology and expertise as one of the industry leaders, we are reinforcing our commitment to do everything we can to combat this escalating pandemic, as quickly as possible.”

“This is a global pandemic, which requires a global effort. In joining forces with our partner Pfizer, we believe we can accelerate our effort to bring a COVID-19 vaccine to people around the world who need it,” said Ugur Sahin, Co-Founder and CEO of BioNTech.
The companies expect to utilize multiple research and development sites from both companies, including in the United States and Germany, to house the activities identified by the collaboration agreement.

The companies will begin collaborating immediately. They will finalize details of the agreement regarding financial terms, and all activities related to development, manufacturing and potential commercialization over the next few weeks.

On March 13, 2020, Pfizer issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to combat COVID-19.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. 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. 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. 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. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. 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.

Pfizer Disclosure Notice:

The information contained in this release is as of March 17, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, BioNTech’s potential COVID-19 mRNA vaccine, BNT162, a letter of intent regarding the co-development and co-commercialization (excluding China) by Pfizer and BioNTech of BNT162 and a Material Transfer and Collaboration Agreement, including their potential benefits, and the expected timing of a Phase 1 trial, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, whether and when a definitive agreement will be reached for the co-development and co-commercialization by Pfizer and BioNTech of BNT162 ; 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 other jurisdictions for BNT162 or any other 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 BNT162 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 BNT162; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities regarding BNT162 and uncertainties regarding the commercial impact of any such recommendations; 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 www.sec.gov and www.pfizer.com.

About BioNTech

Biopharmaceutical New Technologies (BioNTech) 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 infectious diseases alongside its diverse oncology pipeline. 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, and Pfizer.

For more information, please visit www.BioNTech.de.