Monday, April 22, 2013 7:30 am EDT
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK) today announced it has entered into a non-exclusive agreement with Bristol-Myers Squibb to conduct a Phase II clinical trial to evaluate the safety and efficacy of a once-daily oral combination regimen consisting of Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor daclatasvir and Merck's investigational NS3/4A protease inhibitor MK-5172 for the treatment of chronic hepatitis C virus (HCV) infection, genotype 1.
“In HCV, agreements like this that combine novel investigational candidates are important to evaluate the potential of novel oral regimens early in the development cycle,” said Eliav Barr M.D., vice president, Infectious Diseases, Project Leadership and Management, Merck Research Laboratories. “We are pleased to collaborate with Bristol-Myers Squibb to advance this potential all-oral combination.”
The planned initiation of the Phase II clinical trial follows the completion of a Phase I safety evaluation of the investigational combination regimen. Under the agreement, Merck will conduct the Phase II clinical trial. Further clinical development activities beyond the Phase II study are not covered as part of this agreement. Additional details of the collaboration were not disclosed.
MK-5172 is an investigational orally available HCV NS3/4A protease inhibitor currently being evaluated in combination with other approved and investigational medications in Phase II clinical trials. This includes an all oral combination with MK-8742, Merck’s investigational orally available HCV NS5A protease inhibitor.
Merck's Global Commitment to Development of Hepatitis Therapies
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies for our marketed and investigational medicines for the treatment of chronic HCV, extensive research efforts are underway to develop additional oral therapies for viral hepatitis treatment.
Daclatasvir is an NS5A replication complex inhibitor that is being extensively studied as a key component of potential direct-acting antiviral (DAA) based hepatitis C treatment regimens. Studied in more than 4,100 patients to date, daclatasvir is in Phase III development.
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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.
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Caroline Lappetito, (267) 305-7639
Carol Ferguson, (908) 423-4465
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