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


April 22, 2013 6:30 am ET

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.

About MK-5172

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.

About Daclatasvir

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.

About Merck

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
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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.

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 2012 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 (

Caroline Lappetito, (267) 305-7639
Carol Ferguson, (908) 423-4465
Justin Holko, (908) 423-5088

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