What can we help you find?

June 12, 2013 7:00 am ET

Merck, known as MSD outside the United States and Canada, today issued
the following statement regarding this week’s NIDDK-NCI Workshop and the
American Diabetes Association’s (ADA) call for an independent review of
data about the safety of incretin-based diabetes medicines, including
GLP-1 analogs and DPP-4 inhibitors such as JANUVIA^®
(sitagliptin).

“Nothing is more important to Merck than the safety of our medicines and
the people who take them. We welcome opportunities to discuss the data
that support the safety profile of sitagliptin in the treatment of
adults with type 2 diabetes. Type 2 diabetes is a disease with serious
consequences if left untreated,” said Michael Rosenblatt, M.D., chief
medical officer, Merck. “We are committed to participating in an
independent review of our data, and will join the ADA in planning for
such an initiative.”

Merck will participate in the NIDDK-NCI Workshop on
Pancreatitis-Diabetes-Pancreatic Cancer that starts today. During the
meeting, Merck researchers will present data and the company’s
perspective on the safety profile of sitagliptin, including an updated
analysis of data in more than 14,000 patients from 25 randomized
clinical trials of sitagliptin that was recently published¹. Merck
has carefully reviewed all of the available safety data from these
clinical trials, from our nonclinical studies, post-approval adverse
event reports, independent observational studies, and a meta-analysis
conducted by an academic research group of published clinical trials
with DPP-4 inhibitors involving more than 33,000 patients².
Based on that review, Merck remains confident in the safety profile of
sitagliptin.

About JANUVIA^® (sitagliptin) 50 mg, 100 mg
tablets

JANUVIA is indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type 2 diabetes mellitus.

JANUVIA should not be used in patients with type 1 diabetes or for the
treatment of diabetic ketoacidosis.

JANUVIA has not been studied in patients with a history of pancreatitis.
It is unknown whether patients with a history of pancreatitis are at
increased risk of developing pancreatitis while taking JANUVIA.

There have been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with JANUVIA or with any other antidiabetic
drug.

Selected Important Risk Information About JANUVIA^®
(sitagliptin)

JANUVIA is contraindicated in patients with a history of a serious
hypersensitivity reaction to sitagliptin, such as anaphylaxis or
angioedema.

There have been postmarketing reports of acute pancreatitis, including
fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients
taking JANUVIA. After initiating JANUVIA, observe patients carefully for
signs and symptoms of pancreatitis. If pancreatitis is suspected,
promptly discontinue JANUVIA and initiate appropriate management. It is
unknown whether patients with a history of pancreatitis are at increased
risk of developing pancreatitis while taking JANUVIA.

Assessment of renal function is recommended prior to initiating JANUVIA
and periodically thereafter. A dosage adjustment is recommended in
patients with moderate or severe renal insufficiency and in patients
with end-stage renal disease requiring hemodialysis or peritoneal
dialysis. Caution should be used to ensure that the correct dose of
JANUVIA is prescribed.

There have been postmarketing reports of worsening renal function,
including acute renal failure, sometimes requiring dialysis. A subset of
these reports involved patients with renal insufficiency, some of whom
were prescribed inappropriate doses of sitagliptin.

When JANUVIA was used in combination with a sulfonylurea or insulin,
medications known to cause hypoglycemia, the incidence of hypoglycemia
was increased over that of placebo. Therefore, a lower dose of
sulfonylurea or insulin may be required to reduce the risk of
hypoglycemia.

The incidence (and rate) of hypoglycemia based on all reports of
symptomatic hypoglycemia were: 12.2 percent (0.59 episodes per
patient-year) for JANUVIA 100 mg in combination with glimepiride (with
or without metformin), 1.8 percent (0.24 episodes per patient-year) for
placebo in combination with glimepiride (with or without metformin),
15.5 percent (1.06 episodes per patient-year) for JANUVIA 100 mg in
combination with insulin (with or without metformin), and 7.8 percent
(0.51 episodes per patient-year) for placebo in combination with insulin
(with or without metformin).

There have been postmarketing reports of serious hypersensitivity
reactions in patients treated with JANUVIA^® (sitagliptin),
such as anaphylaxis, angioedema, and exfoliative skin conditions
including Stevens-Johnson syndrome. Onset of these reactions occurred
within the first 3 months after initiation of treatment with JANUVIA,
with some reports occurring after the first dose. If a hypersensitivity
reaction is suspected, discontinue JANUVIA, assess for other potential
causes for the event, and institute alternative treatment for diabetes.

Angioedema has also been reported with other dipeptidyl peptidase-4
(DPP-4) inhibitors. Use caution in a patient with a history of
angioedema with another DPP-4 inhibitor because it is unknown whether
such patients will be predisposed to angioedema with JANUVIA. There have
been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with JANUVIA or with any other antidiabetic
drug.

In clinical studies, the adverse reactions reported, regardless of
investigator assessment of causality, in greater than or equal to 5
percent of patients treated with JANUVIA as monotherapy and in
combination therapy and more commonly than in patients treated with
placebo, were upper respiratory tract infection, nasopharyngitis, and
headache.

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. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. 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 (www.sec.gov).

Prescribing Information and Medication Guide for JANUVIA^®
(sitagliptin) are available at http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_pi.pdf
and http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_mg.pdf.

¹ Engel, S. et al. Diabetes Ther. 2013, 4:1

² Current Medical Research & Opinion Vol. 27, No. S3, 2011,
57–64

JANUVIA^® (sitagliptin) is a registered trademark of
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc..

Merck
Media:
Pam Eisele
(267) 664-0282
or
Kim Hamilton
(908) 391-0131
or
Investor:
Carol Ferguson
(908) 423-4465