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Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, is a renowned American multinational pharmaceutical company headquartered in Rahway, New Jersey. Originally the American arm of Germany's Merck Group founded in 1668, Merck has established itself as a global leader in pharmaceuticals and vaccines.
Merck's core business is the development and manufacturing of medications and vaccines spanning several therapeutic areas such as cardiometabolic diseases, cancer, and infections. The company's immuno-oncology platform, particularly strong in cancer treatment, is a significant revenue driver. The firm’s oncology portfolio includes groundbreaking immunotherapies like KEYTRUDA, designed to treat melanoma and other cancers. KEYTRUDA, in combination with other therapies, has shown promising results in reducing cancer recurrence and improving survival rates.
Merck also boasts a robust vaccine business, offering vaccines for pediatric diseases and human papillomavirus (HPV). Their commitment to public health extends to Merck for Mothers, an initiative aimed at improving maternal health globally. In 2024, Merck surpassed its goal early by reaching over 30 million women with programs promoting safe, high-quality maternal care.
The company's animal health division is another sector of its diverse operations, providing solutions to improve animal health and productivity.
From a geographical perspective, nearly half of Merck's sales are generated in the United States. Financially, Merck maintains a solid position with ongoing investments in research and development to fuel innovation. The company is actively engaged in numerous partnerships and collaborative research initiatives to accelerate the development of new therapies.
Merck’s mission is rooted in scientific excellence and an unwavering commitment to improving lives. The company continues to invest in leading-edge research, with over 2,250 ongoing clinical trials, including more than 1,600 trials evaluating combination regimens. This dedication underpins Merck's strategy to address complex health challenges and advance global health.
Merck (NYSE: MRK) will conduct its second-quarter 2022 sales and earnings conference call on July 28 at 8:00 a.m. ET. Company executives will present an overview of Merck's performance for the quarter and its outlook, accessible via a live audio webcast. The call can be joined by dialing designated numbers for the USA and international participants. A replay will be available on Merck's website along with supplemental disclosures. For over 130 years, Merck has been a leader in biopharmaceuticals, advancing health solutions globally.
AstraZeneca and Merck announced a positive recommendation from the European Medicines Agency for LYNPARZA in treating high-risk early breast cancer with gBRCA mutations. This follows the Phase 3 OlympiA trial, showing LYNPARZA improved invasive disease-free survival by 42% and overall survival by 32% compared to placebo. With breast cancer affecting 2.3 million globally in 2020, this treatment could significantly impact outcomes for HER2-negative patients in Europe. The drug is already approved in the U.S., EU, and Japan for various BRCA-related cancers.
Merck has received European Commission approval for KEYTRUDA as the first anti-PD-1 immunotherapy for adjuvant treatment in patients aged 12 and older with stage IIB and IIC melanoma post-complete resection. This decision follows positive outcomes from the Phase 3 KEYNOTE-716 trial, where KEYTRUDA significantly reduced the risk of recurrence by 39% and distant metastasis by 36%. The treatment underscores Merck's commitment to advancing melanoma therapies, addressing a significant public health issue that claimed over 26,000 lives in Europe in 2020.
VAXNEUVANCE has been recommended by the CDC's ACIP as a vaccination option for infants and children, marking the first new pediatric pneumococcal conjugate vaccine in nearly a decade. This 15-valent vaccine can be used in place of the existing 13-valent vaccine for children under 19 years. The recommendation aims to combat serious diseases in children under 5, highlighting its relevance as serotypes 22F and 33F are increasingly responsible for invasive diseases. The final recommendation will be formalized in the CDC's MMWR.
The FDA has approved an expanded indication for VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine by Merck (NYSE: MRK), for use in children aged 6 weeks to 17 years. Clinical trials showed VAXNEUVANCE elicited non-inferior immune responses to PCV13 for shared serotypes and superior responses for serotype 3 and unique serotypes 22F and 33F. This marks the first approval of a pediatric pneumococcal conjugate vaccine in nearly a decade, addressing serious health risks from invasive pneumococcal disease, particularly in children under 5.
Merck (NYSE: MRK) and AstraZeneca announced promising results from the Phase 3 PROpel trial, published in NEJM Evidence, showcasing LYNPARZA combined with abiraterone plus prednisone significantly improved radiographic progression-free survival (rPFS) in metastatic castration-resistant prostate cancer (mCRPC) patients. The trial results indicated a 34% reduction in disease progression risk, with median rPFS at 24.8 months for the combination therapy, compared to 16.6 months for standard treatment. This data could lead to new first-line treatment options for mCRPC.
Merck (MRK) announced the appointment of Chirfi Guindo as the Chief Marketing Officer for Human Health, effective July 1, 2022. Guindo will oversee marketing strategies across various areas, including oncology and vaccines, reporting directly to CEO Robert M. Davis. Guindo brings extensive experience, having previously held senior roles at Biogen and within Merck itself, focusing on product strategy and commercialization. This leadership change is expected to enhance Merck's Human Health portfolio and address significant medical challenges globally.
Merck (NYSE: MRK) announced positive results from the Phase 1/2 study of V116, a 21-valent pneumococcal conjugate vaccine. The study demonstrated V116's safety and immunogenicity in adults aged 18-49 and 50 and older, meeting primary immunogenicity objectives. In Phase 2, V116 showed non-inferior responses to PNEUMOVAX 23 for shared serotypes and superior responses for unique serotypes. V116 targets serotypes responsible for 85% of invasive pneumococcal disease in adults 65 and older. It received Breakthrough Therapy Designation from the FDA for preventing invasive pneumococcal disease.
Merck (NYSE: MRK) announced that the FDA has accepted for review a supplemental Biologics License Application for KEYTRUDA as an adjuvant treatment for stage IB (≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC) after surgical resection. This application is based on the Phase 3 KEYNOTE-091 trial, which showed improved disease-free survival (DFS) for patients. The FDA’s target action date is January 29, 2023. If approved, KEYTRUDA would be the first adjuvant immunotherapy option for these NSCLC stages post-surgery, expanding Merck's oncology portfolio.
Merck (NYSE: MRK) will participate in the 2022 Goldman Sachs 43rd Annual Global Healthcare Conference on
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