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October 3, 2012 7:46 am ET

Phase III Trials of MK-3102 Underway

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 Laboratories.

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 glucose.

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 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).

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