Merck’s Investigational Chronic Hepatitis C Combination Therapy MK-5172/MK-8742 Demonstrates Antiviral Activity in Hard-to

  Merck’s Investigational Chronic Hepatitis C Combination Therapy
  MK-5172/MK-8742 Demonstrates Antiviral Activity in Hard-to-Cure Patients
  with HCV Genotype 1 Infection

        Clinical Findings Support Initiation of C-EDGE Phase 3 Program

Business Wire

WHITEHOUSE STATION, N.J. -- April 11, 2014

Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today
announced interim results from the ongoing C-WORTHy study, a multi-arm Phase 2
clinical trial evaluating the efficacy and safety of an all-oral, once-daily
regimen combining MK-5172, an investigational hepatitis C virus (HCV) NS3/4A
protease inhibitor, and MK-8742, an investigational HCV NS5A replication
complex inhibitor, among patients with chronic HCV Genotype 1 infection (GT1).
Interim analysis of hard-to-cure^1 patients administered MK-5172/MK-8742 with
and without ribavirin (RBV) for 12 or 18 weeks showed sustained viral
response^2 (SVR), 4 to 8 weeks after the completion of therapy (SVR4/8):

  *HCV GT1 infected, treatment-naïve cirrhotic patients, MK-5172/MK-8742
    treated - 97 percent (28/29 and 29/30) for 12 and 18 weeks, and
    MK-5172/MK-8742 plus RBV - 90 percent (28/31) and 97 percent (30/31) for
    12 and 18 weeks, respectively.
  *HCV GT1 infected prior-null responder patients (with or without
    cirrhosis), MK-5172/MK-8742 treated - 91 percent (30/33) and 97 percent
    (29/30) for 12 and 18 weeks, respectively, and MK-5172/MK-8742 plus RBV
    treated 94 percent (30/32) and 100 percent (32/32) for the 12 and 18
    weeks, respectively.
  *Treatment-naïve, non-cirrhotic patients with HCV/HIV co-infection,
    MK-5172/MK-8742 treated for 12 weeks - 90 percent (26/29) and
    MK-5172/MK-8742 plus RBV for 12 weeks 97 percent (28/29).

These data were presented at the 49th Annual Meeting of the European
Association for the Study of the Liver (EASL), also known as The International
Liver Congress™ 2014 in London, UK.

“There is still a need for further options for the most difficult-to-cure
patients, including those with cirrhosis and HCV/HIV co-infection,” said Dr.
Eric Lawitz, MD, vice president, Scientific and Research Development, The
Texas Liver Institute, and clinical professor of medicine, University of Texas
Health Science Center in San Antonio. “These findings provide additional
clinical evidence regarding the potential of MK-5172/MK-8742 in treating a
broad spectrum of HCV patients.”

C-WORTHy Study Design

C-WORTHy is a randomized, dose-responsive, parallel-group, multiple-site,
double-blind clinical trial comparing different patient populations exposed to
different durations of treatment of MK-5172 (100 mg once daily) in combination
with MK-8742 (50 mg once daily) with or without RBV in subjects with chronic
HCV infection. A total of 471 patients with chronic HCV GT1 and HCV RNA levels
of ≥10,000 IU/mL were enrolled in C-WORTHy and randomized across 16 arms.
These results examine hard-to-cure subpopulations, including treatment-naïve
patients with liver cirrhosis (12- and 18-week arms, with and without RBV),
prior-null responder patients with and without cirrhosis (12- and 18-week
arms, with and without RBV) and patients with HIV/HCV co-infection (12-week
arms).

Key Findings for MK-5172/MK-8742

Viral suppression (HCV RNA levels less than 25 IU/mL) was demonstrated for
treatment-naïve patients with cirrhosis, prior-null responder patients with
and without cirrhosis and HIV/HCV co-infected patients by Treatment Week
(TW)12. These levels were maintained at rates between 90 and 100 percent
across patient subgroups through the completion of dosing and at the four-week
treatment follow-up time point (FU4).

Table 1
Interim Analysis of the C-WORTHy Trial: Treatment-Naïve, Cirrhotic Patients
with HCV

GT1 Infection (Intention-to-Treat Analysis (ITT), Excluding Patients Yet to
Reach FU4)
                        MK-5172 +       MK-5172 +      MK-5172 +    MK-5172 +
                        MK-8742 +       MK-8742        MK-8742 +    MK-8742
Parameter              RBV            (NO RBV)      RBV         (NO RBV)
                        (12 Weeks)      (12 Weeks)     (18          (18
                        (N = 31)        (N = 29)       Weeks)       weeks)
                                                       (N = 32)     (N = 31)
SVR4/8, % (n/m†)       90% (28/31)    97% (28/29)   97%         97%
                                                       (30/31)      (29/30)
No SVR, % (n)
Breakthrough           3% (1)         0% (0)        0% (0)      0% (0)
Relapse                7% (2)         3% (1)        0% (0)      3% (1)
Non-virologic          0% (0)         0% (0)        3% (1)      0% (0)
Discontinuation
† m = patients who have reached the FU4 visits (all patients in the 12-week
arms, and 61/63 patients in the 18-week arms have reached FU4).

                                                                             
Table 2
Interim Analysis of the C-WORTHy Trial: Prior Null Responders (~50%
Cirrhotics),

Cirrhotic Patients with HCV GT1 Infection (ITT, Excluding Patients Yet to
Reach FU4)
                         MK-5172 +      MK-5172 +     MK-5172 +    MK-5172 +
                         MK-8742 +      MK-8742       MK-8742 +    MK-8742
Parameter               RBV           (NO RBV)     RBV         (NO RBV)
                         (12 Weeks)     (12 Weeks)    (18          (18
                         (N = 32)       (N = 33)      Weeks)       weeks)
                                                      (N = 33)     (N = 32)
SVR4/8, % (n/m†)        94% (30/32)   91%          100%        97%
                                        (30/33)       (32/32)      (29/30)
No SVR, % (n)
Breakthrough            0% (0)        0% (0)       0% (0)      3% (1)
Relapse                 0% (0)        9% (3)       0% (0)      0% (0)
Non-virologic           6% (2)        0% (0)       0% (0)      0% (0)
Discontinuation
† m = patients who have reached the FU4 visits (all patients in the 12-week
arms, and 62/65 patients in the 18-week arms have reached FU4).

                                                    
Table 3
Interim Analysis of the C-WORTHy Trial:Treatment-Naïve Non-Cirrhotic HCV
GT1-Infected
Patients with HIV Co-Infection (ITT, Excluding Patients Yet to Reach FU4)
                               MK-5172 + MK-8742 +          MK-5172 +
                               RBV                          MK-8742
Parameter                     (12 Weeks)                  (NO RBV)
                               (N = 29)                     (12 Weeks)
                                                            (N = 30)
SVR4/8, % (n/m†)              97% (28/29)                 90% (26/29)
No SVR, % (n)
Breakthrough                  0% (0)                      7% (2)
Relapse                       3% (1)                      0% (0)
Non-virologic                 0% (0)                      3% (1)
Discontinuation
† m = patients who have reached the FU4 visits (only one patient in the
RBV-free arm has not yet reached FU4).
                                                                             

The most common adverse events observed among treatment-naïve patients with
cirrhosis and prior-null responder patients with and without cirrhosis were
fatigue (23% and 28%, respectively), headache (24% and 24%, respectively), and
asthenia (8% and 19%, respectively). The most common adverse events observed
among HIV co-infected patients were headache (8%), asthenia (8%), fatigue
(7%), and sleep disorder (7%). There were no early discontinuations due to
drug-related adverse events and no clinically significant abnormalities
observed in routine laboratory analysis of hematologic markers.

About Merck’s Phase 3 HCV Program: C-EDGE

Based on the results of the Phase 2 clinical program, Merck has initiated
Phase 3 clinical trials for MK-5172/MK-8742. The Phase 3 program, called
C-EDGE, will evaluate the safety and efficacy of MK-5172/MK-8742 with and
without ribavirin in various genotypes and across a broad range of patient
populations with chronic HCV. Study cohorts will include: C-EDGE TN (GT1,
GT4-6; treatment-naive ± cirrhosis), C-EDGE CO-INFXN (GT1, GT4-6;
treatment-naive ± cirrhosis with HIV/HCV co-infection), C-EDGE RECOVERY (GT1,
GT4-6; treatment-naive ± cirrhosis; ± HIV/HCV co-infection on opiate
substitution therapy), and C-EDGE TE (GT1, GT4-6; prior failed treatment with
peginterferon/ribavirin; ± HIV/HCV co-infection). Study information can be
found at www.clinicaltrials.gov.

Merck’s Commitment to HCV

For more than 25 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 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 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 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 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 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).

^1 Defined as treatment-naïve patients with liver cirrhosis, prior-null
responder patients with and without cirrhosis and patients with HIV/HCV
co-infection

^2 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
Media Contacts:
Caroline Lappetito, 267-305-7639
Sarra Herzog, 201-669-6570
or
Investor Contacts:
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