19/04/2012 — BARCELONA, Spain — (BUSINESS WIRE)

MSD (NYSE: MRK), known as Merck in the United States and Canada,
announced final results from a Phase III, open-label study designed to
compare the impact of two anaemia management strategies on sustained
virologic response (SVR)¹ in patients with chronic hepatitis
C virus (HCV) genotype 1 infection treated with VICTRELIS^®
(boceprevir) in combination with PEGINTRON^® (known as
VIRAFERONPEG^® in some countries) (peginterferon alfa-2b) and
ribavirin (P/R). The rates of SVR were 71 percent for both groups: those
patients whose anaemia was managed by ribavirin dose reduction (178/249)
and those patients whose anaemia was managed by the addition of
erythropoietin (EPO) (178/251). The rates of relapse were identical at
10 percent in both groups. These results were presented today for the
first time as part of a late breaker poster session [poster #1419] at
The International Liver Congress™ / 47th European Association for the
Study of the Liver (EASL) annual meeting.

“Chronic hepatitis C treatment regimens with peginterferon alfa and
ribavirin are commonly associated with the development of anaemia, and
this effect is further increased with the addition of boceprevir,” said
Fred Poordad, M.D., chief of hepatology and liver transplantation,
Cedars-Sinai Medical Center, Los Angeles. “The results of this study
show there was no difference in SVR rates among these anaemia management
strategies and that ribavirin dose reduction should be the primary
strategy for managing anaemia in patients taking boceprevir combination
therapy.”

About the Study

In this study, 687 treatment-naïve adult patients with chronic HCV
genotype 1 who had baseline hemoglobin levels of less than or equal to
15 g/dL were enrolled in a multinational, open-label trial and monitored
for the development of anaemia. Patients were treated with a 4-week
lead-in of peginterferon alfa-2b (1.5 mcg/kg/week) and an
investigational dose of ribavirin (600-1,400 mg/day), followed by the
addition of boceprevir (800 mg three times a day) after week 4 for 24 or
44 weeks based on HCV-RNA levels at treatment week 8. Sixteen (16)
percent (111/687) of patients were enrolled in Cohort 1 and assigned a
fixed-dose regimen that included the 4-week lead-in of P/R followed by
the addition of boceprevir for 44 weeks. A protocol amendment was then
added to allow the use of the response-guided therapy (RGT) paradigm,
consistent with findings in the pivotal clinical studies for boceprevir,
and the rest of the patients were enrolled in Cohort 2. The results for
patients receiving the fixed-dose regimen (Cohort 1) versus the RGT
paradigm (Cohort 2) did not differ and have been combined in the
presentation of these data. Patients with a less than 2-log₁₀ decline
in HCV-RNA at week 12, or a greater than or equal to lower limit of
quantification of HCV-RNA at week 24 were considered treatment failures
and were discontinued from the studies.

A total of 500 patients developed anaemia, defined by having hemoglobin
of less than or equal to 10 g/dL (or less than 11 g/dL and were expected
to reach less than or equal to 10 g/dL before the next visit). These
patients were randomized to receive either ribavirin dose reduction (by
200 to 400 mg/d) or the addition of EPO (40,000 IU/week). A secondary
method of anaemia management, such as the addition of EPO, ribavirin
dose reduction or transfusion, was later permitted if a patient’s
hemoglobin reached less than or equal to 8.5 g/dL. Treatment was
discontinued if hemoglobin levels reached less than or equal to 7.5
g/dL. If the initial hemoglobin measurement qualifying a patient as
anaemic was less than or equal to 8.5 g/dL, that patient was not
randomized to one of the anaemia management strategies.

The primary endpoint of the study was the comparison of SVR in patients
who were randomized to receive ribavirin dose reduction or the addition
of EPO.

Safety Findings

The safety profiles were similar regardless of anaemia management
strategy. The most common adverse events (occurring in 30 percent or
more of patients in either group) were anaemia, neutropenia, diarrhea,
dysgeusia, nausea, chills, fatigue, headache, insomnia and alopecia.
There was no difference in the incidence of adverse events between the
ribavirin dose reduction and EPO treatment arms, including
influenza-like symptoms (27 percent each), fatigue (70 percent vs. 71
percent), depression (20 percent vs. 21 percent), anxiety (12 percent
each), shortness of breath (19 percent vs. 21 percent) and
cardiovascular events (14 percent vs. 13 percent), respectively.

Serious adverse events occurred in 16 percent of patients in the
ribavirin dose reduction arm and 13 percent of patients in the EPO arm.
The discontinuation rates were 11 and 13 percent, due to any adverse
event, and 2.0 and 2.4 percent due to anaemia, respectively. There was
one death in the ribavirin dose reduction arm that occurred three weeks
following the end of treatment, with cause of death reported as “sudden
cardiac death”.

About boceprevir

Boceprevir is indicated for the treatment of chronic hepatitis C (CHC)
genotype 1 infection, in combination with peginterferon alfa and
ribavirin, in adult patients with compensated liver disease who are
previously untreated or who have failed previous therapy.

MSD’s global commitment to advancing hepatitis therapy

MSD 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 with boceprevir, extensive research efforts are underway
to develop additional innovative oral therapies for viral hepatitis
treatment.

About MSD

Today’s MSD is a global healthcare leader working to help the world be
well. MSD is a tradename of Merck & Co., Inc., with headquarters in
Whitehouse Station, N.J., U.S.A. 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.

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. Such statements may include,
but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
operating results, the combined company’s plans, objectives,
expectations and intentions and other statements that are not historical
facts. Such statements are based upon the current beliefs and
expectations of Merck’s management and are subject to significant risks
and uncertainties. Actual results may differ from those set forth in the
forward-looking statements.

The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that all of the expected synergies from the merger of Merck
and Schering-Plough will not be realized, or will not be realized within
the expected time period; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; Merck’s ability to accurately predict future market
conditions; dependence on the effectiveness of Merck’s patents and other
protections for innovative products; and the exposure to 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 2011 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).

¹ SVR, the protocol specified primary efficacy endpoint of
the study, is defined as achievement of undetectable HCV-RNA at 24 weeks
after the end of treatment in all randomized patients treated with any
study medication. Per protocol, if a patient did not have a 24-week
post-treatment assessment, the patient’s 12-week post-treatment
assessment was utilized.

VICTRELIS^®, PEGINTRON^® and VIRAFERONPEG^®
are trademarks of Schering Corp., a subsidiary of Merck
& Co., Inc., Whitehouse Station, N.J., USA.
INFC-1029581-0005

CONTACT:

MSD
Media:
Pamela Eisele, 908-423-5042
Lainie Keller,
908-423-4187
Investors:
Carol Ferguson, 908-423-4465

KEYWORDS: United States Europe North America New Jersey Spain

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical

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