Phase IIb Data Showed Merck’s Investigational Once-Weekly DPP-4 Inhibitor MK-3102 Significantly Lowered Blood Sugar in

  Phase IIb Data Showed Merck’s Investigational Once-Weekly DPP-4 Inhibitor
  MK-3102 Significantly Lowered Blood Sugar in Patients with Type 2 Diabetes

                     Phase III Trials of MK-3102 Underway

Business Wire

BERLIN -- October 03, 2012

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today
announced Phase IIb data for MK-3102, the company’s investigational
once-weekly DPP-4 inhibitor in development for the treatment of type 2
diabetes. MK-3102 significantly lowered blood sugar in this 12-week study
compared with placebo, with an incidence of symptomatic hypoglycemia that was
similar to placebo, in patients with type 2 diabetes. These data were
presented today at the 48^th Annual Meeting of the European Association for
the Study of Diabetes (EASD) in Berlin.

“If approved, MK-3102 would provide a novel, once-weekly treatment option to
help reduce blood sugar levels in patients with type 2 diabetes,” said lead
study author Ira Gantz, M.D., Clinical Research, Metabolism, Merck Research

Study Design

The findings reported today are from a multicenter, randomized, double-blind,
placebo-controlled dose-ranging study designed to evaluate five doses of
MK-3102 (0.25, 1, 3, 10 and 25 mg) in patients with type 2 diabetes who had
inadequate glycemic control on diet and exercise.

A total of 685 patients with a mean baseline HbA1c of approximately 8 percent
were randomized: 571 patients received MK-3102 at one of the five once-weekly
doses (0.25 mg, n=113; 1 mg, n=115; 3 mg, n=114; 10 mg, n=115; 25 mg, n=114)
and 114 patients received placebo for 12 weeks. The primary endpoint was
change in HbA1c from baseline at 12 weeks compared to placebo across doses.
The secondary endpoints were 2-hour post-meal glucose and fasting plasma

Study Results

MK-3102 significantly reduced HbA1c compared to placebo (p<0.001) from a mean
baseline of approximately 8 percent across all doses.  In the full study
population at 12 weeks, the placebo-adjusted reduction from baseline in HbA1c
was 0.71 percent with MK-3102 25 mg; 0.67 percent with 10 mg; 0.49 percent
with 3 mg; 0.50 percent with 1 mg; and 0.28 percent with 0.25 mg.

A statistically significant (p<0.001) trend was observed across doses studied
for the secondary endpoints of 2-hour post-meal glucose (PMG) and fasting
blood glucose (FPG). For 2-hour PMG placebo-adjusted reductions from baseline
at week 12 were: MK-3102 25 mg=2.5 mmol/L; 10 mg=2.3 mmol/L; 3 mg=1.9 mmol/L;
1 mg=1.9 mmol/L; 0.25 mg=1.0 mmol/L. For FPG, placebo-adjusted reductions from
baseline at week 12 were MK-3102 25 mg=1.2 mmol/L; 10 mg=0.7 mmol/L; 3 mg=0.8
mmol/L; 1 mg=1.1 mmol/L; 0.25 mg=0.1 mmol/L.

In the study, MK-3102 was generally well tolerated with a safety profile that
was generally similar to placebo.

Diabetes is a chronic, progressive disease that affects 366 million people
globally, including nearly 26 million people in the U.S., however, based on
National Health and Nutrition Examination Survey(NHANES)data from 1999-2006,
more than 40 percent of patients are not at the American Diabetes Association
(ADA) goal of less than 7.0 percent for HbA1c.

“Since the discovery of the DPP-4 inhibitor class, Merck has been actively
committed to advancing the science of how to treat type 2 diabetes. We are
encouraged by these Phase IIb results in patients with type 2 diabetes, and we
are initiating Phase III studies to move MK-3102 forward in the development
process,” said Nancy Thornberry, Senior Vice President and Franchise Head,
Diabetes and Endocrinology, Merck Research Laboratories.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well.
Merck is known as MSD outside 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 and
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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,
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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


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