Merck Animal Health To Acquire Vence |

Virtual fencing system provides advanced technology to cattle producers and ranchers to manage natural resources more effectively

Complements Merck Animal Health's broad portfolio of veterinary pharmaceuticals, vaccines and animal intelligence solutions

Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), announced today that it has signed a definitive agreement under which Merck Animal Health will acquire Vence from its founders and shareholders. Vence is an innovator in virtual fencing for rotational grazing and livestock management. The acquisition is expected to be completed in the third quarter of 2022, subject to customary closing conditions. Specific terms of the agreement were not disclosed.

Vence, a privately held company, provides enhanced technology for producers and ranchers to track, monitor and manage the movement of cattle through a high-tech platform of virtual fencing solutions. Using a computer or smartphone, customers have the capability to manage cattle movement and facilitate rotational grazing. Vence's virtual fencing technology can reduce the need for fencing to subdivide pastures and allows producers and ranchers to manage their cattle and grass inventory, while reducing costs of labor and fencing materials.

"The acquisition of Vence will broaden our portfolio with complementary products and technologies to advance animal health and well-being as well as outcomes for our customers," said Rick DeLuca, president, Merck Animal Health. "Vence is a natural fit with Merck Animal Health's growing portfolio of animal intelligence products that include identification, traceability and monitoring products. This new technology will give cow-calf producers the ability to track their cattle and the ability to move them from pasture to pasture."

"I believe that Merck Animal Health is the best long-term home for this technology and our team. Their unparalleled expertise in the livestock space, ability to develop and scale hardware products, high-quality customer support, and a strong global footprint to expand Vence's market reach make us really excited to join Merck Animal Health," said Frank Wooten, founder and CEO, Vence.

Vence technology is currently available in the United States and parts of Australia.

About Vence Vence was founded to improve the affordability and availability of sustainably raised animal protein. We contribute to more sustainable livestock production by enabling producers to better manage their herds, better utilize their land resources, and ultimately improve the production of more than 20% of protein consumed globally. To enable our vision, we utilize connected sensors, artificial intelligence and leading animal behavioral research to help innovate one of societies oldest and most valuable industries.

About Merck Animal Health At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we've been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world's most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of Merck. Through its commitment to The Science of Healthier Animals ® , Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn , Facebook , Twitter and Instagram .

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2021 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

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Media Contact: Michael Close (973) 937-5467 michael.l.close@merck.com Investor Contact: Peter Dannenbaum (908) 740-1047 peter.dannenbaum@merck.com

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BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, today announced that Dr. Saveri Bhattacharya, a board-certified medical oncologist and recognized expert in breast cancer treatment at the Sidney Kimmel Cancer Center – Jefferson Health in Philadelphia, PA, has been selected to receive support from the Merck Investigator Studies Program (“MISP”). The Investigator Grant is a highly coveted award granted by Merck & Co., Inc. (“Merck”) (NYSE: MRK) to leading investigators with highly innovative clinical studies.

The clinical study being supported is a Phase I/IIa study of BriaCell’s lead clinical candidate, Bria-IMT™, in combination with pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.). Merck will provide KEYTRUDA® for use in the combination study. Patients who match with Bria-IMT™ at least at one HLA type will be eligible for the trial.

Dr. Saveri Bhattacharya is an Assistant Professor of Medical Oncology at Thomas Jefferson University, a member of the NCI-designated Sidney Kimmel Cancer Center – Jefferson Health, a board-certified oncologist experienced in clinical trials in gynecologic oncology and women’s cancers, and a recognized expert in the field of breast cancer treatment. She graduated from Touro University College of Osteopathic Medicine in 2011 and completed her residency in Internal Medicine and fellowship in Hematology/Oncology at The University of Pittsburgh Medical Center. She is currently focused on the clinical trial development in women’s cancers. Dr. Bhattacharya has an impressive list of publications to her credit, including major review articles in both breast cancer chemotherapy and immunotherapy.

The following summarizes the details of the study:

Study Title: A Phase I/II Study of the SV-BR-1-GM Regimen in HLA matched Metastatic Breast Cancer Patients in Combination with Pembrolizumab Principal Investigator: Saveri Bhattacharya, D.O. Title: Assistant Professor Location: Thomas Jefferson University, Sidney Kimmel Cancer Center, Department of Medical Oncology, 1025 Walnut Street, College Building, Suite 700, Philadelphia, PA 19107

“We congratulate Dr. Bhattacharya on receiving this highly competitive award that will accelerate evaluation of the combination of Bria-IMT™ with KEYTRUDA®, which we believe has the potential to create potent anti-tumor immune responses,” stated Dr. Bill Williams, BriaCell’s President and CEO. “We are delighted to collaborate with Merck, Dr. Bhattacharya and her clinical team regarding our shared, enduring commitment to delivering novel therapies to advanced breast cancer patients, a very important unmet medical need.”

“This collaboration is an important step in the continued validation of BriaCell’s innovative immuno-oncology program,” commented Dr. Charles Wiseman, BriaCell’s Scientific Founder and Director. “We look forward to combining our expertise with the strong scientific and clinical expertise of Dr. Bhattacharya and her team to advance the clinical development of our immunotherapies. We are thankful to Merck for its support as we continue to advance our clinical programs to bring hope to advanced breast cancer patients and their families.”

Rationale for the combination study of Bria-IMT™ with KEYTRUDA®

In late 2018, BriaCell announced positive proof of concept data in a Phase I/IIa study of Bria-IMT™ in advanced breast cancer, demonstrating excellent safety and efficacy in patients with HLA matches with Bria-IMT™ (Link). Impressively, the safety and efficacy data appeared similar or superior to that of other advanced or approved drugs for breast cancer when they were at a similar stage of clinical development.

Analysis of blood samples collected in the Phase I/IIa study showed that circulating tumor-associated cells expressed the immune checkpoint molecule programmed death-ligand 1 (“PD-L1”). PD-L1 molecules prevent immune cells from attacking cancer cells. KEYTRUDA® blocks PD-1, which activates PD-L1, and hence promotes the anti-tumor activity of the immune cells. Immune checkpoint inhibitors, such as pembrolizumab (KEYTRUDA®; anti-PD-1), are designed to improve immune activity in cancer patients. These have come to the forefront in the fight against cancer with substantial benefits for some patients.

KEYTRUDA® Combination: BriaCell launched the combination study of Bria-IMT™ with KEYTRUDA® for advanced breast cancer in October 2018 hypothesizing that KEYTRUDA®, which blocks the actions of PD-L1, hence “awakening” a component of the immune system, may further enhance the immune activation of Bria-IMT™ in patients. The combined action may be greater than the sum of their individual effects. Patients will be treated with the combination of Bria-IMT™ and the anti-PD-1 antibody, KEYTRUDA®. BriaCell has already presented encouraging preliminary data (Link) that suggest synergistic and/or additive anti-tumor activity of the combination. In September 2019, BriaCell announced a Remarkable Responder in the combination study of Bria-IMT™ with KEYTRUDA® (Link). The study was subsequently modified to use a combination of Bria-IMT™ with the Incyte PD-1 inhibitor (INCMGA00012) and epacadostat. The combination with KEYTRUDA® was discontinued.

Jefferson, located in the greater Philadelphia region and southern New Jersey, is reimagining health care and education to create unparalleled value. Jefferson is more than 30,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients, preparing tomorrow’s professional leaders for 21st century careers, and discovering new treatments to define the future of care. Thomas Jefferson University, home of Sidney Kimmel Medical College, dates back to 1824 and today comprises 10 colleges and three schools offering 160 undergraduate and graduate programs to more than 8,100 students. Jefferson Health serves patients through millions of encounters each year at 14 hospitals (seven are Magnet® designated by the ANCC for nursing excellence) and over 40 outpatient and urgent care locations throughout the region.

BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.

BriaCell is conducting a Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with immune checkpoint inhibitors such as the Incyte drugs INCMGA00012 (an anti-PD-1 antibody similar to pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)]) and epacadostat, an orally bioavailable small-molecule inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1). The combination study is listed in ClinicalTrials.gov as NCT03328026.

BriaCell currently has a non-exclusive clinical trial collaboration with Incyte Corporation to evaluate the effects of combinations of novel clinical candidates. Under the agreement, Incyte and BriaCell will be evaluating novel combinations of compounds from Incyte’s development portfolio with BriaCell’s drug candidates in advanced breast cancer patients.

BriaCell is also developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS™ immunotherapy treatments are personalized to match the patient without the need for personalized manufacturing. Bria-OTS™, which is expected to cover over 99 percent of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense and complex manufacturing logistics associated with other personalized immunotherapies.

For additional information on BriaCell, please visit: https://briacell.com/.

Cautionary Note Regarding Forward-Looking Information

Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For further information, please contact: BriaCell Therapeutics Corp.: Farrah Dean Manager, Corporate Development Email: farrah@BriaCell.com

Click here to connect with BriaCell Therapeutics Corp. (TSXV:BCT, OTC:BCTXF) for an Investor Presentation

Merck (NYSE:MRK) reported quarterly worldwide sales at US$11.9 billion in Q4 in its financial results for the fourth quarter of 2019 and its full fiscal 2019 year.

As quoted in the press release:

As evidenced by our results and our 2020 guidance, Merck had an extraordinary year and is in a position of operational and financial strength,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “It is this position of strength, born of our focused execution, that gives us the confidence to spin off our Women’s Health, trusted Legacy Brands and Biosimilar products into a new company, which will position us to deliver even greater value to patients and shareholders.”

Click here to read the full press release.

Safety and early efficacy data to be presented from clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors in advanced breast cancer:

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, is pleased to announce that the data of its clinical studies with its lead product candidate, Bria-IMT™, will be presented the at the Annual Symposium of Society of Surgical Oncology (SSO) 2020 – International Conference on Surgical Cancer Care taking place March 25-28 in Boston, MA.

The poster will summarize data of the Bria-IMT™ Phase I/IIa clinical studies of Bria-IMT™ in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), and more recently, Incyte’s INCMGA00012, in advanced breast cancer. The trials are being conducted by Cancer Insight as the CRO at multiple sites across the U.S.

Details of the poster presentations are the following:

Title: Results of a Phase I/IIa Trial of Combination Whole-Cell Targeted Immunotherapy Vaccine and Checkpoint Inhibitor in Treatment of Metastatic/Recurrent Breast Cancer Abstract ID: 3288355 Final ID: P40 Presenter: Dr. Phillip Kemp Bohan Session: ePosters: Immuno-Oncology in Breast Cancer Session Date: March 26, 2020 Session Time: 10:30 – 11:00 a.m. ET Room: Immuno-Oncology Zone Theater (Hynes Convention Center)

Copies of the posters will be posted at the following: https://briacell.com/novel-technology/scientific-publications/.

“We continue to be enthusiastic about our data which indicates additive or synergistic activity of Bria-IMT™ and checkpoint inhibitors in women who have failed a number of prior treatments,” said Dr. Bill Williams, President & CEO of BriaCell. “In particular, we will be discussing a subset of patients that appears to derive tremendous clinical benefit from the combination therapy. While the dose escalation part of the ongoing collaborative study with Incyte is focused on evaluating the safety of the combination, we already see evidence of clinical activity, particularly with Bria-IMT™ in combination with INCMGA00012. We look forward to learning more about the efficacy profile of this novel combination as we continue to treat breast cancer patients with limited therapeutic options and a grim prognosis.”

BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.

For additional information on BriaCell, please visit: https://briacell.com/.

Founded in 2014, Cancer Insight, LLC, is a Texas-based clinical research organization (CRO) dedicated to discovering, developing and testing emerging biotechnologies specializing in cancer immunotherapy. Cancer Insight offers a vertical range of CRO services from trial design to final execution, with a foundation grounded on decades of academic research and clinical trial experience.

For additional information on Cancer Insight, please visit: https://www.cancerinsight.com.

Over the years, the SSO 2020 annual symposium has become a meeting venue for practitioners around the world to discuss and offer expertise on a range of cancer related topics. The 2020 symposium sessions are comprehensive in the range of topics and the depth of expertise delivered. Management of Breast Cancer in Women Age 70+ will be a focused symposium section.

SSO 2020 will feature the debut of SSO HUB, a new and interactive experience that replaces the conventional exhibit hall. The HUB will feature five clinical zones – Breast/Endocrine, HPB, Melanoma/Sarcoma, Colorectal/Upper GI and Immuno-Oncology. Each Zone will have a theater where posters, videos and meet the expert sessions will take place. All of this in addition to the HUB main stage where one may view debates, challenging case reviews, industry spotlights, clinical trial spotlights and team competitions.

For Additional information on the SSO 2020, please visit: https://www.surgonc.org/events/international-conference-on-surgical-cancer-care/.

Cautionary Note Regarding Forward-Looking Information

For further information, please contact: BriaCell Therapeutics Corp.: Farrah Dean Manager, Corporate Development Email: farrah@BriaCell.com Phone: 1-888-485-6340

Click here to connect with BriaCell Therapeutics Corp. (TSXV:BCT, OTC:BCTXF) for an Investor Presentation

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, announced today that it will present at the “Frontiers in Academic Pathology” symposium, hosted by the Icahn School of Medicine at Mount Sinai, to be held on Friday, January 31, 2020 at The New York Academy of Medicine, 1216 Fifth Avenue in New York. The symposium focus will include molecular biomarkers, experimental diagnostics and liquid biopsies, all of which factor heavily in the development of BriaCell’s companion diagnostics under development, including BriaCell’s HLA-matching hypothesis and recently-announced Grade I/II biomarkers.

Dr. Bill Williams, BriaCell’s President & CEO, will be presenting BriaCell’s unique and effective immunotherapy approach at the conference, focusing on the biomarkers noted to date in determining clinical benefit in advanced stage breast cancer.

Following the presentation, a copy will be posted on https://briacell.com/investor-relations/presentations/.

“We are grateful to Icahn School of Medicine at Mount Sinai for their validation in inviting us to share our targeted immunotherapy approach with oncologists and scientists,” stated Dr. Bill Williams. “As we are advancing the development of our novel personalized, off-the-shelf immunotherapy, we are learning more about the clinical application of molecular and pathologic biomarkers to guide us in the treatment of advanced breast cancer patients. This approach will allow us to target therapies to patients most likely to clinically benefit from the treatment.”

“As we develop of our novel personalized immunotherapy for advanced breast cancer patients, we are discovering that our technology and biomarkers may be applicable to a number of tumor types. The key is patient selection based on the molecular, cellular and pathologic characteristics of the cancer. We will share these insights with the attendees of this ground-breaking meeting,” Dr. Williams added.

About Frontiers in Academic Pathology: Transplant and Therapeutic Pathology

The Council for Continuing Medical Education (CME) Accredited course, hosted by Icahn School of Medicine at Mount Sinai, is intended for Pathologists, Oncologists, Transplant Surgeons, Translational and Basic Researches, both in practice and in training, as well as researchers with an interest in Prostate Carcinogenesis and Progression.

The course will address critical areas in transplantation and cell-based therapeutics. At the conclusion of the activity, participants will be able to: 1) Describe the use and limitations of diagnostic modalities and biomarkers in the management of patients undergoing cell-based and organ transplantation. 2) Describe recent and developing approaches toward HLA typing. 3) Describe novel clinical applications of cell-based diagnostics and treatments. 4) Describe developing legislation, regulatory and ethical guidelines for the use of human cells or tissue in implantation, transplantation, or transfer into a human recipient.

For conference information, please Email: cme@mssm.edu.

BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.

For additional information on BriaCell, please visit: https://briacell.com/.

Cautionary Note Regarding Forward-Looking Information

Click here to connect with BriaCell Therapeutics Corp. (TSXV:BCT, OTC:BCTXF) for an Investor Presentation

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, is pleased to provide an update on the previously-announced (Link) top responder (“Remarkable Responder”) in the combination study of its lead candidate, Bria-IMT™, with Incyte’s INCMGA00012, a PD-1 inhibitor.

The patient, who had experienced notable tumor shrinkage while on treatment with Bria-IMT™ in combination with the PD-1 inhibitor pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)], has since transitioned to treatment in combination with INCMGA00012. On this combination treatment, the patient has had a subsequent further remarkable reduction in a breast cancer tumor behind the left eye in the left orbital region. This tumor, which had pushed the eye forward from the skull (known as proptosis), has resolved following 3 months of treatment. The tumor had shrunk by 19% during treatment with the Bria-IMT™ regimen in combination with KEYTRUDA®, and has now completely disappeared during treatment in combination INCMGA00012. While not all of the patient’s tumors have resolved, the proptosis and associated eye problem have been resolved.

BriaCell’s “matching hypothesis” has been further strengthened: The Remarkable Responder matched Bria-IMT™ at 2 HLA loci (HLA-C and HLA-DRB3). BriaCell’s immunotherapy treatment appears most effective when the patient’s HLA-type matches the Bria-IMT™ HLA-type as concluded in prior Phase IIa proof-of-concept work.

“The complete regression of a tumor this large and this advanced, in a patient resistant to 16 previous treatment regimens, is unprecedented in my 50 years of clinical practice,” said Dr. Charles Wiseman, BriaCell’s Scientific Founder and Director. “These very important positive clinical observations support BriaCell’s strategy to continue investigating the combination regimen of Bria-IMT™ with checkpoint inhibitors, and may lead to a new treatment option for breast cancer patients suffering advanced, resistant disease.”

BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.

For additional information on BriaCell, please visit: https://briacell.com/.

Cautionary Note Regarding Forward-Looking Information

For further information, please contact: BriaCell Therapeutics Corp.: Farrah Dean Manager, Corporate Development Email: farrah@BriaCell.com Phone: 1-888-485-6340

Click here to connect with BriaCell Therapeutics Corp. (TSXV:BCT, OTC:BCTXF) for an Investor Presentation

Board of Directors approves quarterly cash dividend of $0.40 per share

Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.40 fourth-quarter 2022 dividend on the company's common stock, payable December 5, 2022, to holders of the Common Stock of record at the close of business on November 4, 2022. The fourth-quarter 2022 cash dividend will be the 336th consecutive quarterly dividend paid by Pfizer.

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 170 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 .

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Media Contact: PfizerMediaRelations@Pfizer.com +1 (212) 733-1226 Investor Contact: IR@Pfizer.com +1 (212) 733-4848

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Pfizer Inc. (NYSE: PFE) announced today an agreement to supply up to six million treatment courses of its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to Global Fund as part of its COVID-19 Response Mechanism (C19RM). The C19RM has been the primary channel for providing grant support to low- and middle-income countries to purchase COVID-19 tests, treatments, personal protective equipment and critical elements of health systems strengthening. PAXLOVID treatment courses will be available for procurement through this mechanism, subject to local regulatory approval or authorization, by the 132 grant-eligible countries determined by Global Fund based on income classification and disease burden.

Pfizer expects supply to be available starting in 2022, pending regulatory authorization or approval and based on country demand. Through Global Fund's framework and mechanism, eligible countries will be offered treatment courses according to Pfizer's tiered pricing approach, where all low- and lower-middle-income countries will pay a not-for-profit price while upper-middle-income countries will pay the price defined in Pfizer's tiered pricing approach. Additional contractual details of the agreement were not disclosed.

"After so much disruption and loss due to COVID-19, we must continue to accelerate access to PAXLOVID as a treatment option for high-risk patients in all regions of the world along with test and treat programs that help get treatment quickly to those in need", said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "This agreement with Global Fund is a critical step that will boost equitable access for high-risk patients in low-and-middle-income countries."

The Global Fund agreement, along with an agreement signed with UNICEF for the supply of up to four million treatment courses for low- and middle-income countries earlier this year, is part of Pfizer's comprehensive global strategy for equitable supply and access of PAXLOVID. This includes a voluntary licensing agreement with Medicines Patent Pool (MPP) to enable the development and distribution of generic versions of Pfizer's oral treatment to further expand long-term global supply and access. MPP has signed sublicense agreements with 38 manufacturers, who will supply the generic versions in 95 low- and lower-middle-income countries. Courses produced by these manufacturers are expected to be available as early as the fourth quarter of 2022.

Pfizer will also provide product donation and funding to the COVID Treatment Quick Start Consortium to support efforts to accelerate COVID-19 testing and improve access to treatments in under-resourced parts of the world.

Pfizer also looks to increase supply of PAXLOVID through An Accord for a Healthier World , a first-of-its-kind initiative to enable sustained, equitable access to high-quality medicines and vaccines for 1.2 billion people living in lower-income countries launched in May 2022 . Through the Accord, Pfizer has committed to provide its patent-protected medicines and vaccines available in the U.S. or European Union, including PAXLOVID, on a not-for-profit basis to 45 lower-income countries and will collaborate with government and global health leaders to address barriers that limit access beyond supply, like diagnosis, education, infrastructure, storage and more.

About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)

PAXLOVID is a SARS-CoV-2 main protease (M pro ) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the M pro , an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, 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 replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. PAXLOVID, however, works intracellularly by binding to the highly conserved M pro (3CL protease) of the SARS-CoV-2 virus to inhibit viral replication. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 and BA.2.

PAXLOVID is generally administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

U.S. FDA Emergency Use Authorization Statement

PAXLOVID has not been approved but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs (i.e., anti-infectives).

PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.

PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product.

Drugs listed in this section are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor such as ritonavir.

PAXLOVID is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions:

PAXLOVID is contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer:

There are limited clinical data available for PAXLOVID. Serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use.

Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. These interactions may lead to:

Consult Table 1 of the Fact Sheet for Healthcare Providers for clinically significant drug interactions, including contraindicated drugs. Drugs listed in Table 1 are a guide and not considered a comprehensive list of all possible drugs that may interact with PAXLOVID. Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications.

Hypersensitivity reactions have been reported with PAXLOVID including urticaria, angioedema, dyspnea, mild skin eruptions, and pruritus. Cases of anaphylaxis, TEN, and Stevens-Johnson syndrome have also been reported with components of PAXLOVID (refer to NORVIR labeling). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.

Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis .

Because nirmatrelvir is co-administered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.

Adverse events in the PAXLOVID group (≥1%) that occurred at a greater frequency (≥5 subject difference) than in the placebo group were dysgeusia (6% and

The following adverse reactions have been identified during post-authorization use of PAXLOVID. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Hypersensitivity reactions Gastrointestinal Disorders: Abdominal pain, nausea General Disorders and Administration Site Conditions: Malaise

Required Reporting for Serious Adverse Events and Medication Errors: The prescribing healthcare provider and/or the provider's designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to PAXLOVID within 7 calendar days from the healthcare provider's awareness of the event.

Submit adverse event and medication error reports to FDA MedWatch using one of the following methods:

In addition, please provide a copy of all FDA MedWatch forms to: http://www.pfizersafetyreporting.com / or by fax (1-866-635-8337) or phone (1-800-438-1985).

PAXLOVID is an inhibitor of CYP3A and may increase plasma concentrations of drugs that are primarily metabolized by CYP3A. Co-administration of PAXLOVID with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring.

Nirmatrelvir and ritonavir are CYP3A substrates; therefore, drugs that induce CYP3A may decrease nirmatrelvir and ritonavir plasma concentrations and reduce PAXLOVID therapeutic effect.

Pregnancy: There are no available human data on the use of nirmatrelvir during pregnancy to evaluate for a drug‑associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Published studies with ritonavir are insufficient to identify a drug‑associated risk of miscarriage. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy.

Lactation: There are no available data on the presence of nirmatrelvir in human or animal milk, the effects on the breastfed infant, or the effects on milk production. A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir. Limited published data reports that ritonavir is present in human milk. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PAXLOVID and any potential adverse effects on the breastfed infant from PAXLOVID or from the underlying maternal condition. Breastfeeding individuals with COVID‑19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID‑19.

Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception.

Pediatrics: PAXLOVID is not authorized for use in pediatric patients younger than 12 years of age or weighing less than 40 kg. The safety and effectiveness of PAXLOVID have not been established in pediatric patients. The authorized adult dosing regimen is expected to result in comparable serum exposures of nirmatrelvir and ritonavir in patients 12 years of age and older and weighing at least 40 kg as observed in adults, and adults with similar body weight were included in the trial EPIC-HR.

Systemic exposure of nirmatrelvir increases in renally impaired patients with increase in the severity of renal impairment. No dosage adjustment is needed in patients with mild renal impairment. In patients with moderate renal impairment (eGFR ≥30 to to 150 mg nirmatrelvir and 100 mg ritonavir twice daily for 5 days. Prescriptions should specify the numeric dose of each active ingredient within PAXLOVID. Providers should counsel patients about renal dosing instructions. PAXLOVID is not recommended in patients with severe renal impairment (eGFR

No dosage adjustment of PAXLOVID is needed for patients with either mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. No pharmacokinetic or safety data are available regarding the use of nirmatrelvir or ritonavir in subjects with severe hepatic impairment (Child-Pugh Class C); therefore, PAXLOVID is not recommended for use in patients with severe hepatic impairment .

About Pfizer: Breakthroughs That Change Patients' Lives

The information contained in this release is as of September 22, 2022. 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 and PAXLOVID (including qualitative assessments of available data, potential benefits, expectations for clinical trials, an agreement to supply up to six million treatment courses of PAXLOVID to Global Fund and the timing of supply thereunder, an agreement with MPP, efforts toward equitable supply and access, including an Accord for a Healthier World, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, planned investment and anticipated manufacturing, distribution and supply), involving 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 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 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 efficacy, safety and tolerability profile observed to date, in additional studies or in larger, more diverse populations following commercialization; uncertainties regarding the commercial impact of the results of the EPIC-SR and EPIC-PEP trials; the ability of PAXLOVID to maintain efficacy against emerging virus variants; the risk that serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use; 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 regulatory 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 emergency use or conditional marketing authorization for any potential indications for PAXLOVID or any of Pfizer's other products or product candidates 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 regulatory authorities in any jurisdictions may approve any applications or submissions for PAXLOVID or any of Pfizer's other products or product candidates that may be pending or filed, 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 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 PAXLOVID or any of Pfizer's other products or product candidates, including development of products or therapies by other companies; risks related to the availability of raw materials for PAXLOVID; manufacturing capabilities or capacity; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand, which would negatively impact our ability to supply the estimated numbers of courses of PAXLOVID within the projected time periods; whether and when additional purchase agreements will be reached; the risk that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; 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, 2021 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 .

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One in two women with advanced ovarian cancer has an HRD-positive tumor

AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA has been approved in China as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

In China, ovarian cancer is the third most common gynecologic cancer, and the five-year survival rate is approximately 39%, with more than 70% of women diagnosed with advanced disease (stage III or IV). In 2020, there were over 55,000 new cases of ovarian cancer diagnosed in China.

The approval by China's National Medical Products Administration was based on an HRD-positive subgroup exploratory analysis of the Phase 3 PAOLA-1 trial, which showed LYNPARZA plus bevacizumab following response to platinum-based chemotherapy demonstrated a substantial progression-free survival (PFS) improvement versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer. The safety and tolerability profile of LYNPARZA in this trial was in line with that observed in prior clinical trials, with no new safety signals. The most common adverse reactions (ARs) occurring in ≥10% of patients treated with LYNPARZA in combination with bevacizumab and at a ≥5% greater frequency compared to bevacizumab alone were nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%) and leukopenia (18%). Additional ARs that occurred in ≥10% of patients receiving LYNPARZA in combination with bevacizumab, irrespective of the frequency compared to bevacizumab alone were diarrhea (18%), neutropenia (18%), urinary tract infection (15%) and headache (14%).

During the European Society for Medical Oncology (ESMO) Congress 2022, updated results were presented from the PAOLA-1 trial, demonstrating that LYNPARZA plus bevacizumab provided a clinically meaningful improvement in overall survival (OS) in an exploratory subgroup analysis of HRD-positive patients with advanced ovarian cancer. These OS results were not statistically significant.

Professor Ding Ma, member of the Chinese Academy of Engineering, said, "Ovarian cancer has the highest fatality rate among gynecologic cancers in China. The emergence of PARP inhibitors and their application in the first-line treatment of ovarian cancer could help patients delay disease progression and achieve long-term remission. In the PAOLA-1 trial, the combination of olaparib and bevacizumab demonstrated clinically meaningful improvements in overall survival. This approval provides HRD-positive patients with a new option for first-line maintenance therapy."

Professor Beihua Kong, chairman of the gynecological oncology branch of the Chinese Medical Association, said, "Ovarian cancer has entered the era of precision medicine, and HRD detection (including BRCA 1/2 mutations) has important clinical value for newly diagnosed patients with advanced ovarian cancer to help guide first-line treatment decisions. The approval of the combination of olaparib and bevacizumab brings a clinically meaningful survival benefit to HRD-positive patients, and further reflects the importance of a precision approach to help guide treatment decisions in ovarian cancer."

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, "The maintenance treatment of LYNPARZA in combination with bevacizumab has shown to both improve progression-free survival and provide a clinically meaningful improvement in overall survival in patients with HRD-positive advanced ovarian cancer following response to platinum-based chemotherapy. I am thrilled we can now bring this targeted treatment option to these patients in China."

Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, "This approval is an important milestone for patients with newly diagnosed advanced ovarian cancer in China and underscores the critical importance of HRD testing for all women with advanced ovarian cancer at the point of diagnosis."

The primary results from the PAOLA-1 trial showed that LYNPARZA plus bevacizumab reduced the risk of disease progression or death by 67% (HR=0.33 [95% CI, 0.25-0.45]). In the subgroup of patients with HRD-positive advanced ovarian cancer, the addition of LYNPARZA to bevacizumab improved PFS to a median of 37.2 versus 17.7 months with bevacizumab alone. The data from the PAOLA-1 trial were published in The New England Journal of Medicine in 2019.

Further results from the five-year analysis of the PAOLA-1 trial recently presented at the ESMO Congress 2022 showed LYNPARZA plus bevacizumab increased median OS to 56.5 months versus 51.6 months with bevacizumab alone in patients with newly diagnosed advanced ovarian cancer. This increase was not statistically significant. In an exploratory subgroup analysis of HRD-positive patients, LYNPARZA plus bevacizumab provided a clinically meaningful improvement in OS, reducing the risk of death by 38% (HR=0.62 [95% CI, 0.45-0.85]) versus bevacizumab, despite PAOLA-1 having 30% stage IV patients.

LYNPARZA in combination with bevacizumab is approved in the U.S., European Union and several other countries as a first-line maintenance treatment for patients with HRD-positive advanced ovarian cancer and is currently under regulatory review in other countries around the world.

PAOLA-1 is a Phase 3, double-blind trial evaluating the efficacy and safety of LYNPARZA added to standard-of-care bevacizumab versus bevacizumab alone as a first-line maintenance treatment for patients with newly diagnosed advanced FIGO stage III-IV high-grade serous or endometroid ovarian, fallopian tube or peritoneal cancer who had a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. AstraZeneca and Merck announced in August 2019 that the trial met its primary endpoint of PFS in the overall trial population.

PAOLA-1 is an ENGOT (European Network of Gynaecological Oncological Trial groups) trial, sponsored by ARCAGY Research (Association de Recherche sur les CAncers dont GYnécologiques) on behalf of GINECO (Groupe d'Investigateurs National des Etudes des Cancers Ovariens et du sein). ARCAGY-GINECO is an academic group specializing in clinical and translational research in patients' cancers and a member of the GCIG (Gynecologic Cancer InterGroup).

There are no contraindications for LYNPARZA.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The median duration of therapy in patients who developed MDS/AML was 2 years (range: 10 years). All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in 0.8% of patients exposed to LYNPARZA monotherapy, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. A pregnancy test is recommended for females of reproductive potential prior to initiating treatment.

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

Venous Thromboembolic Events: Including pulmonary embolism, occurred in 7% of patients with metastatic castration-resistant prostate cancer who received LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1% of patients receiving enzalutamide or abiraterone plus ADT in the PROfound study. Patients receiving LYNPARZA and ADT had a 6% incidence of pulmonary embolism compared to 0.8% of patients treated with ADT plus either enzalutamide or abiraterone. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.

ADVERSE REACTIONS—First-Line Maintenance BRCA m Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary tract infection (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

Most common adverse reactions (Grades 1-4) in ≥10% of patients treated with LYNPARZA/bevacizumab and at a ≥5% frequency compared to placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%) and leukopenia (18%). In addition, the most common adverse reactions (≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%) and headache (14%).

In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%) and decrease in platelets (35%).

ADVERSE REACTIONS—Maintenance Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%) and dyspepsia (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the maintenance setting (SOLO-2/Study 19 ) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONS—Adjuvant Treatment of g BRCA m, HER2-Negative, High-Risk Early Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: nausea (57%), fatigue (including asthenia) (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: decrease in lymphocytes (77%), increase in mean corpuscular volume (67%), decrease in hemoglobin (65%), decrease in leukocytes (64%), and decrease in absolute neutrophil count (39%).

ADVERSE REACTIONS—g BRCA m, HER2-Negative Metastatic Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in > 25% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

ADVERSE REACTIONS—First-Line Maintenance g BRCA m Metastatic Pancreatic Adenocarcinoma

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration Resistant Prostate Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

INDICATIONS for LYNPARZA in the United States

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for:

First-Line Maintenance BRCA m Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated (g BRCA m or s BRCA m) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab

In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:

Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Adjuvant Treatment of g BRCA m, HER2-Negative, High-Risk Early Breast Cancer

For the adjuvant treatment of adult patients with deleterious or suspected deleterious g BRCA m, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

g BRCA m HER2-Negative Metastatic Breast Cancer

For the treatment of adult patients with deleterious or suspected deleterious g BRCA m , human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance g BRCA m Metastatic Pancreatic Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious g BRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

HRR Gene-mutated Metastatic Castration Resistant Prostate Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please see complete Prescribing Information , including Medication Guide .

LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR.

LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.

Ovarian cancer is the eighth most common cancer in women worldwide. Globally, there were more than 313,000 new cases of ovarian cancer in 2020 and over 207,000 deaths. The five-year survival rate of newly diagnosed advanced ovarian cancer patients has typically been 30-50%. Roughly half of women with advanced ovarian cancer have HRD-positive tumors, including those with a BRCA mutation, and one in four women have a BRCA mutation. The primary aim of first-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.

Homologous recombination deficiency, which defines a subgroup of ovarian cancer, encompasses a wide range of genetic abnormalities, including BRCA mutations and beyond. As with BRCA gene mutations, HRD interferes with normal cell DNA repair mechanisms and confers sensitivity to PARP inhibitors including LYNPARZA.

About the AstraZeneca and Merck strategic oncology collaboration

In July 2017, AstraZeneca and Merck, known as MSD outside of the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize certain oncology products, including LYNPARZA, the world's first PARP inhibitor, for multiple cancer types. Working together, the companies will develop these products in combination with other potential new medicines and as monotherapies. Independently, the companies will develop these oncology products in combination with their respective PD-L1 and PD-1 medicines.

Merck's focus on cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials .

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

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Media: Melissa Moody, (215) 407-3536 Chrissy Trank, (640) 650-0694

Investor: Peter Dannenbaum, (908) 740-1037 Damini Chokshi, (908) 740-1807

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Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, November 1, 2022. The purpose of the call is to provide an update on Pfizer's results, as reflected in the company's Third Quarter 2022 Performance Report, to be issued that morning.

To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors . Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance of the conference call.

You can also listen to the conference call by dialing either 800-456-4352 in the United States and Canada or 785-424-1086 outside of the United States and Canada. The passcode is "35795".

The transcript and webcast replay of the call will be made available on our web site at www.pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.

About Pfizer: Breakthroughs That Change Patients' Lives

Disclosure Notice: The webcast may include forward-looking statements about, among other things, our anticipated operating and financial performance, reorganizations, business plans, strategy and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, clinical trial results and other developing data, revenue contribution, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on these opportunities; manufacturing and product supply; and our efforts to respond to COVID-19, including the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) and our oral COVID-19 treatment (Paxlovid), that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. A description of these risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2021 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 .

The forward-looking statements in the webcast speak only as of the original date of the webcast. Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments.

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Media Contact: PfizerMediaRelations@Pfizer.com +1 (212) 733-1226 Investor Contact: IR@Pfizer.com +1 (212) 733-4848

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Phase 2 study evaluating an investigational weekly oral combination treatment regimen of islatravir and Gilead Sciences' lenacapavir to resume with lower dose of islatravir

Monthly oral islatravir development for pre-exposure prophylaxis (PrEP) to be discontinued; Merck continues to evaluate other long-acting PrEP candidates

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the company will initiate a new Phase 3 clinical program with once-daily islatravir for the treatment of people with HIV-1 infection. These new Phase 3 studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir (DOR/ISL). One study will evaluate DOR/ISL in previously untreated adults with HIV-1 infection and two studies will evaluate DOR/ISL as a switch in antiretroviral therapy (ART) in adults with HIV-1 infection who are virologically suppressed. Certain study participants currently enrolled in once-daily treatment studies with DOR 100 mg/ISL 0.75 mg will have the option of transitioning to a new study with the lower islatravir dose. The U.S. Food and Drug Administration (FDA) has reviewed and agreed with this plan. The investigational new drug application (IND) for the once-daily oral DOR/ISL treatment program remains under a partial clinical hold for any studies that would use doses higher than the dose to be studied in the new Phase 3 program. Refer here for more information on the islatravir clinical hold.

The Phase 2 clinical trial ( NCT05052996 ) evaluating an investigational oral once-weekly combination treatment regimen of islatravir and Gilead's lenacapavir in adults with HIV-1 infection who are virologically suppressed will resume under an amended protocol with a lower dose of islatravir. The IND under which the islatravir + lenacapavir once-weekly treatment regimen is being investigated remains under a partial clinical hold for any studies that would use weekly oral islatravir doses higher than the doses considered for the revised clinical program. Islatravir and lenacapavir, in combination, are investigational and not approved for use. The safety and efficacy of this combination has not yet been established.

Additionally, after careful evaluation and analysis, Merck will discontinue the development of once-monthly oral islatravir for PrEP. Participants in the ongoing Phase 3 PrEP once-monthly oral studies will continue to be monitored. The company remains committed to developing compounds for long-acting HIV prevention and believes in the potential of the nucleoside reverse transcriptase translocation inhibitor (NRTTI) mechanism. A Phase 1b study in adults with HIV-1 infection assessing MK-8527, a novel NRTTI candidate, will commence shortly ( NCT05494736 ). Merck will continue to engage with key stakeholders as it works to help address the unmet need in HIV prevention.

"We are grateful to the study investigators and the many participants in the trials of islatravir. Following extensive evaluations and consultation with FDA, we are pleased to be able to initiate our new Phase 3 clinical program to evaluate islatravir for the treatment of HIV-1 infection," said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "We continue to believe in the potential of the NRTTI mechanism and we are evaluating additional candidates with the goal of helping to address unmet needs in HIV prevention. As part of this, we are pleased to continue our partnership with the Bill & Melinda Gates Foundation as we continue to evaluate potential long-acting PrEP opportunities."

Merck's Commitment to HIV

For more than 35 years, Merck has been committed to scientific research and discovery (R&D) in HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV, with the goal of reducing the growing burden of infection worldwide. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that impede progress toward ending the epidemic.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

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Brian Plummer bplummer@gilead.com

Jacquie Ross Investors_relations@gilead.com

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Pfizer today announced positive top-line results from its pivotal E.U. Phase 3 study in infants (NCT04546425) evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD), pneumonia, and acute otitis media caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population.

The study had three coprimary outcomes, associated with immunogenicity responses one month after the second and third doses of a three-dose vaccination series given at approximately 2, 4, and 11-12 months of age of 20vPnC compared to Prevenar 13 ® . For the non-inferiority (NI) co-primary objective of immunoglobulin G (IgG) geometric mean concentrations (GMCs) one month after Dose 3 at 11-12 months of age, 19 of the 20 serotypes met the NI criteria with only one serotype narrowly missing. For the NI co-primary objective of IgG GMCs one month after Dose 2, 16 of the 20 serotypes met NI. Finally, for the third NI co-primary objective of the percentage of participants with predefined serotype-specific IgG concentrations one month after Dose 2, nine of the 20 serotypes met the NI criteria. All 20 serotypes showed increased booster responses from post dose 2 to post dose 3 which are indicative of immunological memory and long-term protection. All 20 vaccine serotypes also showed strong functional antibody responses as measured by the opsonophagocytic assay (OPA) post-dose 2 and post dose 3 similar to Prevenar ® and Prevenar 13 ® . The totality of data is therefore directionally consistent with prior clinical experience with Prevenar ® and Prevenar 13 ® after 2 and 3 infant doses, both of which have demonstrated effectiveness in a three-dose schedule against the serotypes contained in the vaccine in post-licensure studies.

In summary, the totality of these positive 20vPnC data, combined with the experience with Prevenar 13 ® in this schedule, demonstrates that the 20vPnC candidate, if approved, is likely to help protect against all 20 vaccine serotypes in a three-dose vaccine series.

"Today marks another important milestone in the 20vPnC pediatric program, with these data demonstrating 20vPnC's potential to provide the most comprehensive pneumococcal serotype coverage of any available pneumococcal conjugate vaccine," said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "Based on the totality of immunogenicity and safety data, we feel confident that 20vPnC is likely to be protective against all vaccine serotypes in a three-dose series. We are thankful to everyone who worked on or participated in this study, and we look forward to hopefully being able to provide infants with more robust and meaningful protection against more pneumococcal disease-causing serotypes in the near future."

The safety profile of 20vPnC was similar to Prevenar 13 ® in this schedule, and concomitant use with common pediatric vaccines were supported.

Pfizer plans to file these data by the end of this year with the European Medicines Agency (EMA). These positive data mark the conclusion of pivotal topline readouts for the 20vPnC pediatric program. Pfizer will also seek to present and publish outcomes from this clinical trial at a future date once safety and immunogenicity data have been fully analyzed.

About the 20vPnC Phase 3 Pediatric Program

In 2020, Pfizer initiated the Phase 3 clinical trial program for the pediatric indication for 20vPnC. Four core Phase 3 pediatric studies will help expand the data on the safety, tolerability, and immunogenicity of 20vPnC. These studies collectively enrolled approximately 4,700 infants and 800 toddlers and children of all ages including:

Pfizer's 20vPnC pediatric vaccine candidate includes 13 serotypes already included in Prevenar 13 ® – 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. The seven new serotypes included in 20vPnC are global causes of invasive pneumococcal disease (IPD), and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis. Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the EU and globally.

On Feb 14, 2022, the European Commission Decision was adopted for APEXXNAR ® (20vPnC) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older.

About Pfizer: Breakthroughs That Change Patients' Lives

The information contained in this release is as of September 19, 2022. 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 20vPnC vaccine candidate, including its potential benefits, results from the Phase 3 study (NCT04546425) in infants and anticipated regulatory submissions, 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, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our 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 our clinical studies; whether and when any biologic license applications may be filed in particular jurisdictions for 20vPnC for any potential indications; whether and when any such applications may be approved by regulatory authorities, which will depend on a 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 such product candidate 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 20vPnC; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding 20vPnC 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, 2021 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 .

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Media Relations US Contact: +1 (212) 733-1226

EU Contact: +44 (0) 1737 332 335 EUPress@pfizer.com

Investor Relations +1 (212) 733-4848 IR@pfizer.com

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