Merck Enters Agreement with Bristol-Myers Squibb to Conduct a Phase II
Clinical Trial Evaluating Combination of Investigational Oral Candidates
MK-5172 and Daclatasvir for Chronic Hepatitis C
WHITEHOUSE STATION, N.J. -- April 22, 2013
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
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
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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Caroline Lappetito, (267) 305-7639
Carol Ferguson, (908) 423-4465
Justin Holko, (908) 423-5088
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