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Merck to Present New Data from Clinical Studies Evaluating Investigational Hepatitis C Treatment Grazoprevir/Elbasvir (MK-5172/MK-8742) at the 65th American Association for the Study of Liver Diseases Annual Meeting
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Interim results of C-SWIFT, a Phase 2 study evaluating ultra-short treatment durations of grazoprevir/elbasvir (MK-5172/MK-8742) plus sofosbuvir, to be presented
Results from the C-WORTHy study, a Phase 2 clinical trial evaluating grazoprevir/elbasvir (MK-5172/MK-8742) across multiple patient populations, including difficult-to-cure, to be presented
Wednesday, October 8, 2014
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new data from clinical studies of the company's investigational, oral, once-daily, fixed-dose combination chronic hepatitis C treatment grazoprevir/elbasvir (MK-5172/MK-8742) are scheduled to be presented at the 65th American Association for the Study of Liver Diseases (AASLD) Annual Meeting, also known as The Liver Meeting®. The meeting is scheduled to take place at the John B. Hynes Veterans Memorial Convention Center in Boston, Mass., from Nov. 7 - 11, 2014.
"Tremendous progress has been made in recent years in the understanding of chronic hepatitis C and its treatment, but it is important that we continue to advance the development of therapies to treat diverse populations of HCV-infected patients," said Dr. Eliav Barr, vice president, Infectious Diseases, Merck Research Laboratories. "Merck's broad and systematic hepatitis C clinical development program is designed with this goal in mind, and is generating important insights into the potential of grazoprevir/elbasvir across multiple viral genotypes and patient populations."
New data will also be presented for MK-3682 (formerly IDX21437), an investigational oral nucleotide prodrug NS5B inhibitor acquired earlier this year by Merck as part of its purchase of Idenix Pharmaceuticals.
Key Presentations of Grazoprevir/Elbasvir
Data from clinical trials evaluating grazoprevir/elbasvir will be the subject of two oral presentations, as well as three poster presentations, including a late-breaking abstract:
· Monday, November 10: As part of the late-breaking abstract poster session, interim Phase 2 data from C-SWIFT, a clinical trial evaluating the efficacy and safety of ultra-short treatment durations with grazoprevir/elbasvir plus sofosbuvir will be presented. C-SWIFT is the first study to report sustained viral responsei (SVR) data from regimens as short as four weeks in genotype 1 (GT1) treatment-naïve patients (Abstract #LB-33).
· Monday, November 10: Data from a clinical trial evaluating the health-related quality of life (HRQOL) impact of grazoprevir/elbasvir without the use of pegylated beta interferon (IFN) and ribavirin (RBV) versus grazoprevir/elbasvir treatment regimens containing RBV with or without IFN will be presented as part of a poster session (Abstract #1455).
· Tuesday, November 11: Final results (SVR24) from the C-WORTHy Study (Parts A and B) evaluating the efficacy and safety of grazoprevir/elbasvir with or without RBV in GT1 infected patients will be presented during two oral sessions.
- The first session will focus on cirrhotic and prior null-responder patients (Abstract #196).
- The second session will focus on mono-infected and HIV/HCV co-infected treatment-naïve, non-cirrhotic patients (Abstract #236).
· Tuesday, November 11: Results from a study evaluating the pharmacokinetics and safety of grazoprevir/elbasvir in patients with end-stage renal disease (ESRD), hemodialysis (HD) or severe renal impairment (SRI) will be presented as part of a poster session (Abstract #1940).
Presentation of MK-3682 (IDX21437) Data
· Tuesday, November 11: results from a Phase 1/2a study assessing seven-day dosing of MK-3682 in subjects infected with HCV will be presented as an AASLD presidential poster of distinction during the Hepatitis C: Preclinical Development poster session (Abstract #1974).
For abstracts and program information, please visit: http://www.aasld.org.
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, oral, once-daily, fixed-dose combination chronic HCV treatment, consisting of grazoprevir (MK-5172), an investigational oral, once-daily HCV NS3/4A protease inhibitor, and elbasvir (MK-8742), an investigational oral, once-daily HCV NS5A replication complex inhibitor. In October 2013, Merck announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to grazoprevir/elbasvir for treatment of chronic HCV infection. Breakthrough therapy is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Merck's Commitment to HCV
For nearly 30 years, Merck has been at the forefront of the response to the HCV epidemic. Merck employees are dedicated to applying their scientific expertise, resources and global reach to deliver innovative healthcare solutions that support people living with HCV worldwide.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. 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. 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 healthcare legislation in the United States and internationally; global trends toward healthcare 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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i Defined as HCV RNA below the limit of quantification or below the limit of detection at the last visit on record - 4, 8, 12, or 24 weeks after the completion of therapy
Contact:
Merck
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Pam Eisele, 267-305-3558
Sarra Herzog,
201-669-6570
or
Investors:
Joe Romanelli, 908-423-5185
Justin Holko, 908-423-5088
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