Pfizer Announces Additional Phase 2/3 Study Results Confirming Robust Efficacy of Novel COVID-19 Oral Antiviral Treatment Candidate in Reducing Risk of Hospitalization or Death

• Final data available from all high-risk patients enrolled in EPIC-HR study (n= 2,246) confirmed prior results of interim analysis showing PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo; no deaths compared to placebo in non-hospitalized, high-risk adults with COVID-19
• The above data have been shared with the U.S. Food and Drug Administration (FDA) as part of an ongoing rolling submission for Emergency Use Authorization (EUA)
• Separately, interim analyses of an ongoing second study in standard-risk adults (EPIC-SR) showed a 70% reduction in hospitalization and no deaths in the treated population, compared to placebo, in the secondary endpoint; the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days, as compared to placebo, was not met. The study continues
• An approximate 10-fold decrease in viral load at Day 5, relative to placebo, was observed in both EPIC-HR and EPIC-SR, indicating robust activity against SARS-CoV-2 and representing the strongest viral load reduction reported to date for a COVID-19 oral antiviral agent
• Recent in vitro data confirm that nirmatrelvir is a potent inhibitor of the Omicron 3CL protease, which, combined with existing in vitro antiviral and protease inhibition data from other Variants of Concern (VoC) including Delta, indicates that PAXLOVID will retain robust antiviral activity against current VoCs as well as other coronaviruses

NEW YORK — ( BUSINESS WIRE ) — Pfizer Inc. ( new york stock exchange : PFE ) nowadays announced final results from an analysis of all 2,246 adults enrolled in its Phase 2/3 EPIC-HR ( E evaluation of P rotease I nhibition for C OVID-19 in H igh- R isk Patients ) trial of its novel COVID-19 oral antiviral campaigner PAXLOVID™ ( nirmatrelvir [ PF-07321332 ] tablets and ritonavir tablets ). These results were reproducible with the interim analysis announced in November 2021, showing PAXLOVID importantly reduced the gamble of hospitalization or death for any induce by 89 % compared to placebo in non-hospitalized, bad pornographic patients with COVID-19 treated within three days of symptom attack. In a secondary end point, PAXLOVID reduced the hazard of hospitalization insurance or death for any induce by 88 % compared to placebo in patients treated within five days of symptom attack, an increase from the 85 % observed in the interim analysis. The EPIC-HR data have been shared with the U.S. Food and Drug Administration ( FDA ) as separate of an ongoing roll submission for Emergency Use Authorization ( EUA ). “ This news provides farther documentation that our oral antiviral candidate, if authorized or approved, could have a meaningful affect on the lives of many, as the data further corroborate the efficacy of PAXLOVID in reducing hospitalization and death and show a substantial decrease in viral load. This underscores the discussion campaigner ’ s potential to save the lives of patients around the world, ” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “ Emerging variants of concern, like Omicron, have exacerbated the necessitate for accessible treatment options for those who contract the virus, and we are convinced that, if authorized or approved, this electric potential treatment could be a critical tool to help quell the pandemic. ” EPIC-HR Final Results

In the concluding analysis of the primary end point from all patients enrolled in EPIC-HR, an 89 % reduction in COVID-19-related hospitalization or death from any campaign compared to placebo in patients treated within three days of symptom attack was observed, reproducible with the interim analysis. In accession, a coherent safety profile was observed. 0.7 % of patients who received PAXLOVID were hospitalized through Day 28 following randomization ( 5/697 hospitalized with no deaths ), compared to 6.5 % of patients who received placebo and were hospitalized or died ( 44/682 hospitalized with 9 subsequent deaths ). The statistical significance of these results was high ( p < 0.0001 ). In a secondary end point, PAXLOVID reduced the risk of hospitalization insurance or death for any lawsuit by 88 % compared to placebo in patients treated within five days of symptom onset ; 0.8 % of patients who received PAXLOVID were hospitalized or died through Day 28 following randomization ( 8/1039 hospitalized with no deaths ), compared to 6.3 % of patients who received placebo ( 66/1046 hospitalized with 12 subsequent deaths ), with gamey statistical meaning ( p < 0.0001 ). relative risk reduction was 94 % in patients 65 years of senesce or older, one of the populations at highest hazard for hospitalization or death ; 1.1 % of patients who received PAXLOVID were hospitalized through Day 28 ( 1/94 hospitalized with no deaths ), compared to 16.3 % of patients who received placebo ( 16/98 hospitalized with 6 deaths ), with high statistical significance ( p < 0.0001 ). In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID as compared to 12 ( 1.2 % ) deaths in patients who received placebo. In the EPIC-HR trial, in a secondary end point, SARS-CoV-2 viral cargo at service line and Day 5 have been evaluated for 499 patients. After accounting for baseline viral load, geographic region, and serology condition, PAXLOVID reduced viral load by approximately 10-fold, or 0.93 log10 copies/mL, relative to placebo, indicating robust natural process against SARS-CoV-2 and representing the strongest viral warhead decrease reported to date for an oral COVID-19 agentive role. Treatment-emergent adverse events were comparable between PAXLOVID ( 23 % ) and placebo ( 24 % ), most of which were mild in volume. Fewer serious adverse events ( 1.6 % vs. 6.6 % ) and discontinuance of sketch drug due to adverse events ( 2.1 % vs. 4.2 % ) were observed in patients dosed with PAXLOVID, compared to placebo, respectively. All other secondary endpoints for this discipline, which are available on clinicaltrials.gov ( NCT04960202 ), were not yet available for this follow-up. Full analyze data are expected to be released later this calendar month and submitted to a peer-reviewed publication. EPIC-SR Interim Results Interim analyses of the EPIC-SR ( E valuation of P rotease I nhibition for C OVID-19 in S tandard- R isk Patients ) Phase 2/3 sketch, which included unvaccinated adults who were at standard risk ( i.e., broken risk of hospitalization or death ) a well as vaccinated adults who had one or more hazard factors for progressing to severe illness, showed that the novel elementary end point of self-reported, sustain relief of all symptoms for four consecutive days, as compared to placebo, was not met. The key secondary end point showed a 70 % reduction in hospitalization and no deaths in the treat population for any lawsuit compared to placebo. additionally, there was approximately a 10-fold, or 1 log10 copies/mL, decrease in viral cargo compared to placebo, coherent with results from the Phase 2/3 EPIC-HR study. The data were reviewed by an autonomous Data Monitoring Committee ( DMC ) and, based on the totality of the data available, the DMC recommended that the trial continue. At the EPIC-SR interim analysis, which included 45 % of the trial ’ randomness planned registration, 0.6 % of those who received PAXLOVID were hospitalized following randomization ( 2/333 hospitalized with no deaths ), compared to 2.4 % of patients who received placebo and were hospitalized or died ( 8/329 hospitalized with no deaths ). A follow-on psychoanalysis at 80 % of enroll patients was reproducible with these findings. In this analysis, 0.7 % of those who received PAXLOVID were hospitalized following randomization ( 3/428 hospitalized with no deaths ), compared to 2.4 % of patients who received placebo and were hospitalized or died ( 10/426 hospitalized with no deaths ) ; p=0.051. Treatment-emergent adverse events were comparable between PAXLOVID ( 22 % ) and placebo ( 21 % ), most of which were mild in volume. Rates of good adverse events ( 1.4 % vs. 1.9 % ) and discontinuance of study drug due to adverse events ( 2.1 % vs. 1.2 % ) were besides comparable between PAXLOVID and placebo. All early secondary endpoints for this learn, which are available on clinicaltrials.gov ( NCT05011513 ), were not even available for this follow-up. The sketch is now in full enrolled, and far data will be released upon analysis of the fully study data expected later this calendar month. About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) PAXLOVID is an investigational SARS-CoV-2 protease inhibitor antiviral therapy. It was developed to be administered orally so that, if authorized or approved, it can be prescribed at the first gestural of infection or at first awareness of an exposure – potentially helping patients avoid austere illness ( which can lead to hospitalization and death ) or avoid disease development following contact with a family extremity who contracts COVID-19 – subjugate to the clinical success of the rest of the EPIC exploitation program. Nirmatrelvir [ PF-07321332 ], which originated in Pfizer laboratories, is designed to block the natural process of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metamorphosis, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus. Nirmatrelvir is designed to inhibit viral rejoinder at a stage known as proteolysis, which occurs before viral RNA reproduction. In preclinical studies, nirmatrelvir did not demonstrate attest of mutagenic DNA interactions. stream variants of refer can be repellent to treatments that are focused on the spike heel protein expressed on the airfoil of the SARS-CoV-2 virus, due to the mutations in this region. PAXLOVID, however, works intracellularly on the protease of the SARS-CoV-2 virus by inhibiting viral replica. Nirmatrelvir has shown coherent in vitro antiviral action against the previously identified variants of concerns ( i.e., alpha, beta, delta, da gamma, lambda, and mu ). In addition, nirmatrelvir potently inhibited the 3CL protease associated with Omicron in an in vitro biochemical assay. This indicates nirmatrelvir ’ s potential to maintain robust antiviral activity against Omicron. Additional in vitro antiviral studies with this form are afoot. If authorized or approved, PAXLOVID will be administered at a acid of 300 mg ( two 150 mg tablets ) of nirmatrelvir with one 100 magnesium tablet of ritonavir, given twice-daily for five days. One box contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all necessitate doses for a full five-day treatment naturally. About the Phase 2/3 EPIC-HR Study Top-Line Results

The concluding analysis of the primary end point evaluated data from 2,246 adults who were enrolled by November 4, 2021. At the clock of the decision to stop recruit patients, registration was at 75 % of the 3,000 planned patients from clinical test sites across North and South America, Europe, Africa, and Asia, with 41 % of patients located in the United States. Enrolled individuals had a laboratory-confirmed diagnosis of mild to moderate SARS-CoV-2 infection within a five-day period and were required to have at least one feature or underlie medical discipline associated with an increased risk of developing severe illness from COVID-19. Each affected role was randomized ( 1:1 ) to receive PAXLOVID or placebo orally every 12 hours for five days. About the Phase 2/3 EPIC-SR Study Interim Analyses The primary analysis of the interim data, consisting of the first 45 % of patients enrolled in the study, included 673 adults, of whom 338 received PAXLOVID and 335 received placebo. At the meter of the interim analyses, EPIC-SR had reached its design registration of more than 1,140 adults from clinical trial sites across North and South America, Europe, Africa, and Asia, and the United States. Enrolled individuals had a laboratory-confirmed diagnosis of balmy to moderate SARS-CoV-2 infection within a five-day period and were either unvaccinated adults who were at standard risk ( i.e., gloomy risk of hospitalization or death ) or vaccinated adults who had one or more gamble factors for progressing to severe illness from COVID-19. Each patient was randomized ( 1:1 ) to receive PAXLOVID or placebo orally every 12 hours for five days. About the EPIC Development Program The EPIC ( E valuation of P rotease I nhibition for C OVID-19 ) Phase 2/3 development program for nirmatrelvir ; ritonavir consists of three clinical trials spanning a across-the-board spectrum of patients, including adults who have been exposed to the virus through family contacts, equally well as adults at both standard risk and high risk of progressing to severe illness.​ In July 2021, Pfizer initiated the first base of these trials, known as EPIC-HR ( E evaluation of P rotease I nhibition for C OVID-19 in H igh- R isk Patients ), a randomized, double-blind study of non-hospitalized pornographic patients with COVID-19, who are at high gamble of progressing to severe illness. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration ( FDA ), Pfizer ceased further registration into the study in early November 2021 due to the overwhelm efficacy demonstrated in results from an interim analysis. Data have been submitted to the FDA as part of its submission for Emergency Use Authorization, and findings from the EPIC-HR interim analysis have been submitted to a peer-reviewed daybook for issue. In August 2021, Pfizer began the Phase 2/3 EPIC-SR ( E evaluation of P rotease I nhibition for C OVID-19 in S tandard- R isk Patients ), to evaluate efficacy and base hit in patients with a confirmed diagnosis of SARS-CoV-2 infection who are at standard risk ( i.e., low risk of hospitalization or death ). In September, Pfizer initiated the Phase 2/3 EPIC-PEP ( E evaluation of P rotease I nhibition for C OVID-19 in P ost- E xposure P rophylaxis ) to evaluate efficacy and base hit in adults exposed to SARS-CoV-2 by a family extremity. This test is ongoing. For more information on the EPIC Phase 2/3 clinical trials for PAXLOVID, visit clinicaltrials.gov. 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 criterion for quality, guard and value in the discovery, development and industry of health worry products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance health, prevention, treatments and cures that challenge the most fear diseases of our time. consistent with our province as one of the universe ‘s premier innovative biopharmaceutical companies, we collaborate with health worry providers, governments and local communities to support and expand access to reliable, low-cost health care around the world. For more than 170 years, we have worked to make a remainder for all who rely on us. We routinely post information that may be important to investors on our web site at www.Pfizer.com. In accession, 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. Disclosure Notice The data contained in this free is as of December 14, 2021. Pfizer assumes no obligation to update advanced statements contained in this release as the result of fresh information or future events or developments. This release contains advanced data about Pfizer ’ s efforts to combat COVID-19 and Pfizer ’ s investigational oral antiviral campaigner PAXLOVID ( including qualitative assessments of available data, including interim data, likely benefits, expectations for clinical trials, a submission to the FDA requesting Emergency Use Authorization ( EUA ), the predict time of data readouts, regulative submissions, regulative approvals or authorizations, likely to maintain antiviral action against variants, planned investment and anticipate fabrication, distribution and add ), involving significant 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 the ability to meet expect clinical endpoints, beginning and/or completion dates for clinical trials, regulative submission dates, regulative blessing dates and/or establish dates, vitamin a well as risks associated with preclinical and clinical data ( including the Phase 2/3 interim data and the other data discussed in this release ), including the possibility of unfavorable modern preclinical, clinical or guard data and far analyses of existing preclinical, clinical or safety data, including the risk that concluding results from EPIC-SR could differ from the interim data ; the ability to produce comparable clinical or other results including efficacy, safety and tolerability visibility observed to date, in extra studies or in larger, more divers populations following commercialization ; the hazard that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community broadly, and by regulative authorities ; whether regulative authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies ; whether and when any drug applications or submissions to request hand brake function or conditional market mandate for any likely indications for PAXLOVID may be filed in particular jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate ; whether and when regulative authorities in any jurisdictions may approve any such applications or submissions for PAXLOVID ( including the submission for EUA pending with the FDA ), which will depend on countless factors, including making a determination as to whether the merchandise ’ s benefits outweigh its know risks and determination of the product ’ sulfur efficacy and, if approved, whether it will be commercially successful ; decisions by regulative authorities impacting label or market, fabricate processes, safety and/or early matters that could affect the handiness or commercial likely of PAXLOVID, including development of products or therapies by other companies ; risks related to the handiness of raw materials for PAXLOVID ; the risk that we may not be able to create or scale up manufacturing capacity on a timely footing or maintain access to logistics or supply channels commensurate with ball-shaped necessitate, which would negatively impact our ability to supply the estimate numbers of courses of PAXLOVID within the project fourth dimension periods ; whether and when extra buy agreements will be reached ; the gamble that demand for any products may be reduced or no longer exist ; uncertainties regarding the impact of COVID-19 on Pfizer ’ south business, operations and fiscal results ; and competitive developments. A foster description of risks and uncertainties can be found in Pfizer ’ s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 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 ”, deoxyadenosine monophosphate 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 hypertext transfer protocol : //www.sec.gov/ and www.pfizer.com. View reservoir version on businesswire.com : hypertext transfer protocol : //www.businesswire.com/news/home/20211214005548/en/

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