MSD Provides Update on European Medicines Agency Marketing Authorisation Application for Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir
MSD, known as Merck (NYSE:MRK) in the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has responded to the company’s marketing authorisation application (MAA) for elbasvir/grazoprevir (50mg/100mg), which is under review for the treatment of adult patients with chronic hepatitis C (HCV) infection. The CHMP advised MSD that the application will now be reviewed on a standard timetable, rather than the accelerated assessment timeline previously announced. Under the revised timeline, MSD anticipates a European Commission decision in mid-2016.
“We are excited about the potential of elbasvir/grazoprevir and look forward to continuing our discussions with the European Medicines Agency to bring this important medicine to appropriate patients with chronic hepatitis C in the European Union,” said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories, a U.S.-based division of Merck & Co., Inc., Kenilworth, N.J., USA.
Today's MSD is a global health care leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Kenilworth, N.J., USA. 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 healthcare through far-reaching policies, programs and partnerships.
Forward-Looking Statement of Merck & Co. Inc., Kenilworth, N.J., USA
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 2014 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 ).
Doris Li, (908) 246-5701
Sarra Herzog, (201) 669-6570
Teri Loxam, (908) 740-1986
Justin Holko, (908) 740-1879
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