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May 12, 2016 7:30 am ET

Additional Analyses from the TECOS Cardiovascular Safety Trial of JANUVIA^® (sitagliptin) Also to Be Presented

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that researchers will present data from clinical trials
of its investigational diabetes pipeline, JANUVIA^®
(sitagliptin), and new real-world research in more than 20 scientific
data presentations at the 76^th Scientific Sessions of the
American Diabetes Association (ADA) being held in New Orleans, June
10-14, 2016. New investigational clinical trial data to be presented
include the first Phase 3 results for ertugliflozin, an oral SGLT2
inhibitor in development with Pfizer for patients with type 2 diabetes,
and for MK-1293, Merck’s follow-on biologic insulin glargine candidate
being evaluated for patients with type 1 and type 2 diabetes. Additional
analyses will also be presented from the TECOS (Trial Evaluating
Cardiovascular Outcomes with Sitagliptin) cardiovascular safety trial of
JANUVIA.

“At Merck, we have a long-term commitment to diabetes research and
advancing the care of people living with diabetes around the world,”
said Peter Stein, M.D., vice president, late stage development, diabetes
and endocrinology, Merck. “We look forward to presenting new clinical
trial data and results of several studies from real-world settings at
this year’s American Diabetes Association Scientific Sessions.”

Indications and Usage for JANUVIA (sitagliptin)
25 mg, 50 mg and 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.

Selected Important Risk Information about JANUVIA

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.

Selected Important Risk Information about JANUVIA continued below.

Abstracts

Select abstracts to be presented include the following:

Ertugliflozin

• Ertugliflozin: Glycemic control as monotherapy in patients with T2DM
  (Abstract #130-LB, Sunday, June 12, 12:00-2:00 p.m. CT)
• Effect of ertugliflozin plus sitagliptin on glycemic control vs.
  either treatment alone in subjects with T2DM inadequately controlled
  with metformin (Abstract #125-LB, Sunday, June 12, 12:00-2:00 p.m. CT)

Ertugliflozin (MK-8835) is being developed in collaboration with Pfizer,
Inc. for the treatment of patients with type 2 diabetes.

MK-1293

• Efficacy and safety of MK-1293 insulin glargine compared with
  originator insulin glargine (Lantus) in type 2 diabetes (T2D)
  (Abstract #926-P, Saturday, June 11, 11:30 a.m.-1:30 p.m. CT)
• A single-dose euglycemic clamp study in subjects with type 1 diabetes
  demonstrating pharmacokinetic and pharmacodynamic similarity between
  MK-1293 insulin glargine and originator insulin glargine (Lantus)
  (Abstract #946-P, Saturday, June 11, 11:30 a.m.-1:30 p.m. CT)
• Efficacy and safety of MK-1293 insulin glargine compared with
  originator insulin glargine (Lantus) in type 1 diabetes (T1D)
  (Abstract #296-OR, Monday, June 13, 9:30-9:45 a.m. CT)

MK-1293 is being developed by Merck for the treatment of patients with
type 1 and type 2 diabetes, and Samsung Bioepis is partially funding its
development.

JANUVIA^® (sitagliptin)

• Assessing the safety of sitagliptin in patients with type 2 diabetes
  and chronic kidney disease in the Trial Evaluating Cardiovascular
  Outcomes with Sitagliptin (TECOS) (Abstract #1181-P, Sunday, June 12,
  12:00-2:00 p.m. CT)
• A pooled analysis: Reduction of hypoglycemic event rate with
  sitagliptin compared with sulfonylurea (Abstract #1112-P, Sunday, June
  12, 12:00-2:00 p.m. CT)
• Sitagliptin and risk of fractures in type 2 diabetes: Results from the
  TECOS trial (Abstract #587-P, Monday, June 13, 12:00-2:00 p.m. CT)

Real-World Data – Type 2 Diabetes

• Clinical inertia in patients with type 2 diabetes mellitus at a large,
  integrated, U.S. health care system (Abstract #1442-P, Sunday, June
  12, 12:00-2:00 p.m. CT)
• Frequency of documented hypoglycemia among U.S. patients with type 2
  diabetes and insulin treatment (Abstract #396-P, Sunday, June 12,
  12:00-2:00 p.m. CT)
• Direct medical costs of severe hypoglycemic events among type 2
  diabetes patients in UK (Abstract #1464-P, Sunday, June 12, 12:00-2:00
  p.m. CT)
• History of hypoglycemic events more than knowledge predicts fear of
  hypoglycemia in T2DM (Abstract #400-P, Sunday, June 12, 12:00-2:00
  p.m. CT)
• A retrospective cohort study on conversion to diabetes among a
  prediabetic adult population in China (Abstract #1423-P, Sunday, June
  12, 12:00-2:00 p.m. CT)
• Survival in people with type 2 diabetes with lower glycosylated
  hemoglobin (Abstract #173-OR, Saturday, June 11, 5:30-5:45 p.m. CT)
• External validation of the UK Prospective Diabetes Study risk
  equations in 14,740 Israel type 2 diabetes patients (Abstract #354-OR,
  Monday, June 13, 5:30-5:45 p.m. CT)
• Intensification of therapy and time until A1c goal attainment among
  patients with new-onset type 2 diabetes (T2D) who fail metformin
  monotherapy within a large integrated health system (Abstract #363-OR,
  Monday, June 13, 5:45-6:00 p.m. CT)
• Prevalence of diabetes in U.S. Medicaid pediatric population,
  2002-2013 (Abstract #156-LB, Sunday, June 12, 12:00-2:00 p.m. CT)

For more information, including a complete list of abstract titles at
the meeting, please visit: http://professional.diabetes.org/meeting/scientific-sessions/76th-scientific-sessions.

Selected Important Risk Information about JANUVIA (continued)

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% (0.59 episodes/patient-year) for
JANUVIA 100 mg in combination with glimepiride (with or without
metformin), 1.8% (0.24 episodes/patient-year) for placebo in combination
with glimepiride (with or without metformin), 15.5% (1.06
episodes/patient-year) for JANUVIA 100 mg in combination with insulin
(with or without metformin), and 7.8% (0.51 episodes/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, 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 postmarketing reports of severe and disabling arthralgia
in patients taking DPP-4 inhibitors. The time to onset of symptoms
following initiation of drug therapy varied from 1 day to years.
Patients experienced relief of symptoms upon discontinuation of the
medication. A subset of patients experienced a recurrence of symptoms
when restarting the same drug or a different DPP-4 inhibitor. Consider
DPP-4 inhibitors as a possible cause for severe joint pain and
discontinue drug if appropriate.

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 ≥5% 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

For 125 years, Merck has been a global health care 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 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
health care through far-reaching policies, programs and partnerships.
For more information, visit www.merck.com
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and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
and expectations of the company’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; the company’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 the company’s patents
and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

The company 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 the company’s 2015 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).

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

Merck
Media:
Doris Li, 908-246-5701
Kristen Drake, 908-236-4223
or
Investors:
Justin Holko, 908-740-1879