Company to Initiate Phase 3 Clinical Development Program in Q2 2014
March 24, 2014 07:30 AM Eastern Daylight Time
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that new Phase 2 data for its two investigational hepatitis C virus (HCV) treatments - MK-5172, an investigational HCV NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor – are scheduled to be presented at the 49th Annual Meeting of the European Association for the Study of the Liver (EASL), also known as The International Liver Congress™ 2014. The data are from Merck’s overall Phase 2 clinical program. The meeting will take place in London, United Kingdom, April 9 - 13, 2014.
“These additional clinical data for MK-5172 and MK-8742 build upon the clinical evidence collected to date across a broad spectrum of patients with chronic HCV”
Based on the results of the Phase 2 program, Merck is initiating a Phase 3 clinical trial program, to be named C-EDGE. The C-EDGE program is designed to evaluate these investigational treatments across genotypes and in different HCV subpopulations, including patients with chronic kidney disease, HIV/HCV co-infection, and cirrhosis.
“These additional clinical data for MK-5172 and MK-8742 build upon the clinical evidence collected to date across a broad spectrum of patients with chronic HCV,” said Dr. Eliav Barr, vice president, Infectious Disease, Merck Research Laboratories. “Based on these data, we are pursuing a Phase 3 clinical program for these potentially important investigational medicines.”
In October 2013, Merck announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to the investigational combination MK-5172/MK-8742 for treatment of chronic HCV infection.
Selected Presentations for MK-5172/MK-8742:
- Efficacy and Safety of MK-5172 and MK-8742 ± Ribavirin in Hepatitis C Genotype 1 Infected Patients with Cirrhosis or Previous Null-Response: The C-WORTHY Study. Lawitz, E. et al. Oral presentation #O61: April 11, 2014, 4:00-4:15 p.m. BST.
- Efficacy and Safety of the All-Oral Regimen, MK-5172/MK-8742 ± RBV for 12 Weeks in GT1 HCV/HIV Co-infected Patients: The C-WORTHY Study. Sulkowski, M. et al. Oral presentation #O63: April 11, 2014, 4:30-4:45 p.m. BST.
- Safety and Efficacy of the All-Oral Regimen of MK-5172/MK-8742 ± Ribavirin in Treatment-naïve, Non-cirrhotic Patients with Hepatitis C Virus Genotype 1 Infection: The C-WORTHY Study. Hezode, C et al. Oral Presentation #O10: April 10, 2014, 4:45-5:00 p.m. BST.
Merck’s Commitment to HCV
For more than 25 years, Merck has been at the forefront of the response to the HCV epidemic, and has helped to make a difference through our proud legacy of commitment to innovation, collaborating with the community, and expanding global access to medicines. Merck is dedicated to applying our scientific expertise, resources and global reach to deliver healthcare solutions that support people living with HCV worldwide.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care 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. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Merck Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’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; Merck’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 Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck 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 Merck’s 2013 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).
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