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.
The information contained in this release is as of April 9, 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 statements about Pfizer’s efforts to battle COVID-19, including potential clinical trial timing, potential timing of vaccine availability and potential of the various candidates being studied, that involve 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, the uncertainties inherent in research and development, including uncertainties regarding the results of screening and the ability to meet anticipated pre-clinical and clinical endpoints, commencement and/or completion dates for our pre-clinical and clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable pre-clinical or clinical data; the risk that pre-clinical and 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 our clinical studies; whether and when drug applications for any potential antiviral compounds, vaccines or other candidates may be filed or approved in any jurisdictions, 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; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such products, including development of products or therapies by other companies; our manufacturing capabilities and capacity; 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 http://www.sec.gov and www.pfizer.com.