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Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced positive data from six preclinical studies showing that molnupiravir, an experimental oral antiviral drug, effectively targets the Omicron variant of SARS-CoV-2 in vitro. These findings bolster confidence in molnupiravir as a treatment for high-risk adults with mild to moderate COVID-19. The drug has been authorized for use in over 10 countries, including the U.S. and U.K. Merck is committed to ensuring global access to molnupiravir, having produced millions of treatment doses and entered into numerous supply agreements.
Merck (NYSE: MRK) announced the European Commission's approval of KEYTRUDA as monotherapy for adults with renal cell carcinoma (RCC) at high risk of recurrence after nephrectomy. The approval is based on the Phase 3 KEYNOTE-564 trial, which showed a 32% reduction in the risk of disease recurrence or death. KEYTRUDA is the first immunotherapy approved in Europe for this adjuvant setting. Additionally, updated data at 29.7 months showed a 37% reduction in recurrence risk. This treatment is now available across all EU member states and select territories.
Merck (NYSE: MRK) has declared a quarterly dividend of $0.69 per share for Q2 2022. This dividend will be paid on April 7, 2022 to shareholders recorded by March 15, 2022. The company continues to focus on developing medicines and vaccines for critical health challenges, affirming its commitment to global health. Merck remains dedicated to enhancing access to healthcare and pursuing a leadership role in biopharmaceutical research. For further details about the company, visit www.merck.com.
Merck (NYSE: MRK) announced that the FDA has issued a Complete Response Letter (CRL) for its New Drug Application of gefapixant, a selective P2X3 receptor antagonist intended for treating refractory chronic cough (RCC) and unexplained chronic cough (UCC). The CRL requests further data on efficacy measurement but does not raise safety concerns. Merck is committed to addressing FDA feedback and will consult with the agency on the next steps. Meanwhile, gefapixant has been approved in Japan under the brand name LYFNUA for similar conditions.
Merck (NYSE: MRK) and Eisai announced the publication of Phase 3 KEYNOTE-775/Study 309 trial results in the New England Journal of Medicine. This pivotal study evaluated the combination of KEYTRUDA and LENVIMA against chemotherapy for patients with advanced endometrial carcinoma post-platinum regimen. Key findings indicate significant improvements in overall survival and progression-free survival. Following these results, KEYTRUDA plus LENVIMA is approved in the U.S. and Europe for specific patients, addressing a critical need in treating endometrial carcinoma.
Merck (NYSE: MRK) announced that Frank Clyburn, executive vice president and president of Human Health, will leave the company on Feb. 1, 2022, for a leadership opportunity elsewhere. Clyburn has contributed significantly over 14 years, enhancing Merck’s oncology leadership and driving sustainable growth. His departure raises questions about future leadership for Human Health, with announcements pending. CEO Robert M. Davis expressed gratitude for Clyburn's strategic and operational excellence, underscoring the importance of strong leadership for ongoing business momentum.
Merck (NYSE: MRK) announced the final results from the Phase 3 KEYNOTE-394 trial at ASCO GI 2022, investigating KEYTRUDA plus best supportive care (BSC) for patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. The trial demonstrated a 21% reduction in the risk of death, with a median overall survival (OS) of 14.6 months for KEYTRUDA compared to 13.0 months for placebo. Key findings showed a 26% reduction in disease progression risk and an overall response rate (ORR) of 12.7%. However, treatment-related adverse events were higher in the KEYTRUDA group.
Merck Animal Health, part of Merck & Co. (NYSE:MRK), announced findings from its latest Veterinary Wellbeing Study, conducted with the AVMA. The survey, the third since 2017 and the first post-COVID-19, highlights increased mental health challenges among U.S. veterinarians and staff. Key findings include that 92% reported increased stress, with 88% citing student debt as a significant concern. Merck pledged $100,000 to support AVMA's mental health initiatives. The pandemic exacerbated staffing shortages, with serious psychological distress rising to 9.7% among veterinarians and 18.1% among support staff.
Merck (NYSE: MRK) has announced a significant partnership with UNICEF to supply up to 3 million courses of molnupiravir, its investigational COVID-19 antiviral, to low- and middle-income countries in the first half of 2022. This initiative aims to ensure equitable access to the treatment after regulatory approvals. The drug has been authorized in various countries, including the US, UK, and Japan. Merck has committed to manufacturing millions of doses and granting licenses to generic manufacturers to enhance affordability and availability in developing regions.
Merck (NYSE: MRK) announced positive results from the Phase 3 KEYNOTE-091 trial, showing that its anti-PD-1 therapy, KEYTRUDA, significantly improves disease-free survival (DFS) in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) post-surgery. The study met one of its dual primary endpoints, although the endpoint related to high PD-L1 expressers did not achieve statistical significance. The findings support KEYTRUDA’s potential in early-stage NSCLC treatment. Results are set for presentation at a medical meeting and regulatory submission.