What can we help you find?

May 30, 2018 3:15 pm ET

KENILWORTH, N.J., May 23, 2018 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today confirmed that 4,320 doses of its investigational Ebola Zaire vaccine V920 (rVSV∆G-ZEBOV-GP) were shipped to the World Health Organization (WHO) in Geneva, Switzerland in two lots last week. This action is part of the response effort to the recent Ebola outbreak declared by the WHO on May 8, 2018 in the Democratic Republic of the Congo. These shipped doses are in addition to 4,300 doses that were already prepositioned in Geneva with the WHO last year. Those doses were deployed and arrived in Kinshasa on May 16. Merck is working with the WHO and Médecins Sans Frontières (also known as MSF; Doctors without Borders) to support the possible implementation of an Expanded Access clinical protocol designed to allow implementation of V920 in a ring vaccination approach in the DRC.

Merck expects that additional shipments of the investigational vaccine may need to be sent as the response to the outbreak continues.

About V920 (rVSV∆G-ZEBOV-GP)

V920 is an investigational vaccine designed to prevent the onset of Ebola Zaire virus disease. The vaccine is currently being studied in Phase 3 clinical trials. It was initially engineered by scientists from the Public Health Agency of Canada’s National Microbiology Laboratory and subsequently licensed to a subsidiary of NewLink Genetics Corporation. In late 2014, Merck licensed V920 from NewLink Genetics. Since that time, Merck has worked closely with NewLink Genetics and a number of external collaborators to enable a broad clinical development program with funding from the US Government including the Department of Health and Human Service’s Biomedical Advanced Research Development Authority (BARDA) and the Department of Defense’s Defense Threat Reduction Program/Joint Vaccination Acquisition Program (DTRA/JVAP) among others. Additional research evaluating the safety and efficacy of V920 is ongoing.

Merck is responsible for the research, development, manufacturing, and regulatory efforts in support of V920. The company has committed to working closely with other stakeholders to accelerate the continued development, production and, if licensed, distribution of the vaccine. Merck had intended to file for registration of V920 with the European Medicines Agency (EMA) in July of this year. We are now planning to file with EMA and FDA in 2019. The exact dates for submission to regulatory agencies will depend upon discussions we will be having with each of them.

Merck’s Commitment to Infectious Diseases

For more than 80 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious disease. In addition to a combined portfolio of antibiotic and antifungal medicines, vaccines, and medicines for HIV and HCV. Merck has multiple programs that span discovery through late-state development. Merck currently has 10 compounds in Phase 2/Phase 3 clinical trials for the potential treatment or prevention of infectious diseases.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. 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., Kenilworth, N.J., U.S.A.

This news release of Merck & Co., Inc., Kenilworth, 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 products that the products 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.

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 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 2017 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media Contacts:

Pamela Eisele, (267) 305-5338

Skip Irvine, (267) 305-0338

Investor Contacts:

Teri Loxam, (908) 740-1986

Michael DeCarbo, (908)-740-1807