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September 17, 2015 7:30 am ET

Presents Pivotal Data for Omarigliptin, Merck’s Investigational Once-Weekly DPP-4 Inhibitor, and Additional Data from the TECOS CV Safety Trial, at European Association for the Study of Diabetes Annual Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
provided an update today on its diabetes portfolio and re-affirmed the
company’s comprehensive, long-term commitment to patients with diabetes.
Merck has a proud history in helping patients with type 2 diabetes.
Since launching JANUVIA^® (sitagliptin) in 2006 as the first
DPP-4 inhibitor in the United States, Merck has continued to collaborate
with academic and industry partners on advances in the care of patients
with diabetes, and to research and develop innovative treatment options.
At the 51^st European Association for the Study of Diabetes
(EASD) Annual Meeting in Stockholm, Sweden, new Phase 3 data on Merck’s
investigational once-weekly oral DPP-4 inhibitor, omarigliptin, and
additional findings from the Trial Evaluating Cardiovascular Outcomes
with Sitagliptin (TECOS) of Merck’s once-daily DPP-4 inhibitor, JANUVIA,
are being presented.

“At Merck, our priorities are driven by unmet medical need and our
belief in Merck’s ability to advance patient care, which is why diabetes
remains a top priority. Our teams are focused on bringing forward both
scientific insights and new treatment options that can help patients and
physicians better manage the challenges of diabetes,” said Sam Engel,
M.D., associate vice president, Merck clinical research, diabetes and
endocrinology. “We have a strong portfolio of established medicines, and
continue to strengthen our role in the future of diabetes treatment
through our own research and development, strategic collaborations and
acquisitions.”

Our flagship medicine, JANUVIA, was approved in 2006 in the United
States and is now available in more than 127 countries worldwide. More
than 83 million prescriptions of JANUVIA and JANUMET^® (sitagliptin
and metformin HCl) have been dispensed worldwide. The recent
presentation of the results of TECOS—the CV safety trial of more than
14,000 patients with type 2 diabetes—has provided important new
information on JANUVIA, and additional analyses of safety data from
TECOS will be presented on Sept. 18, 2015 at the EASD Annual Meeting.
The results of the TECOS CV safety trial will be submitted to the U.S.
Food and Drug Administration (FDA) and other regulatory agencies this
year.

Indications and Limitations of Use 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.

Other filing updates include:

• In August 2015, omarigliptin, an investigational once-weekly DPP-4
  inhibitor in development for the treatment of adults with type 2
  diabetes, was endorsed by the Special Committee of the Japan
  Pharmaceuticals and Medical Devices Agency (PDMA) and a final decision
  on approval of omarigliptin in Japan is expected soon. The clinical
  development program for omarigliptin, O-QWEST (Omarigliptin Q
  Weekly Efficacy and Safety in Type 2
  Diabetes), includes 10 Phase 3 clinical trials involving approximately
  8,000 patients with type 2 diabetes. The company plans to submit a New
  Drug Application (NDA) to the U.S. FDA for omarigliptin by the end of
  2015. Other worldwide regulatory submissions will follow.
• Merck plans to submit MK-1293, Merck’s insulin glargine candidate for
  the treatment of patients with type 1 and type 2 diabetes, for
  regulatory approval within the next six months. MK-1293 is being
  developed as part of Merck’s biosimilar collaboration with Samsung
  Bioepis Co., Ltd.
• Merck is collaborating with Pfizer on the development of the
  investigational SGLT2 inhibitor ertugliflozin, along with fixed-dose
  combinations of ertugliflozin and sitagliptin, and ertugliflozin and
  metformin. The alliance initiated Phase 3 clinical trials in late 2013
  and expects to submit applications for regulatory approval in the U.S.
  for ertugliflozin and the two fixed-dose combination tablets by the
  end of 2016.
• Merck has initiated a Phase 2a trial for MK-8521, an investigational
  GLP-1/ glucagon receptor co-agonist.

Selected Important Risk Information about JANUVIA^® (continued)

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% (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.

Indications and Limitations of Use for JANUMET^®
(sitagliptin and metformin HCl) tablets

JANUMET is indicated, as an adjunct to diet and exercise, to improve
glycemic control in adults with type 2 diabetes mellitus when treatment
with both sitagliptin and metformin is appropriate. JANUMET should not
be used in patients with type 1 diabetes or for the treatment of
diabetic ketoacidosis. JANUMET 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 JANUMET.

Selected Important Risk Information about JANUMET

WARNING: LACTIC ACIDOSIS

Lactic acidosis is a rare but serious complication that can occur
because of metformin accumulation. The risk increases with conditions
such as sepsis, dehydration, excess alcohol intake, hepatic impairment,
renal impairment, and acute congestive heart failure. The onset is often
subtle, accompanied only by nonspecific symptoms such as malaise,
myalgias, respiratory distress, increasing somnolence, and nonspecific
abdominal distress.

Laboratory abnormalities include low pH, increased anion gap, and
elevated blood lactate. If acidosis is suspected, JANUMET should be
discontinued and the patient hospitalized immediately [see Warnings
and Precautions].

JANUMET is contraindicated in patients with renal impairment (serum
creatinine levels greater than or equal to 1.5 mg/dL for men and greater
than or equal to 1.4 mg/dL for women or abnormal creatinine clearance);
hypersensitivity to metformin hydrochloride; acute or chronic metabolic
acidosis, including diabetic ketoacidosis; or history of a serious
hypersensitivity reaction to JANUMET or sitagliptin (one of the
components of JANUMET), such as anaphylaxis or angioedema.

Temporarily discontinue JANUMET in patients undergoing radiologic
studies involving intravascular administration of iodinated contrast
materials, because use of such products may result in acute alteration
of renal function. Avoid use in patients with hepatic disease.
Temporarily discontinue for intercurrent serious conditions, infection,
or surgery.

There have been postmarketing reports of worsening renal function,
including acute renal failure, sometimes requiring dialysis.

Before initiation of JANUMET and at least annually thereafter, renal
function should be assessed and verified as normal. In patients in whom
development of renal dysfunction is anticipated, particularly in elderly
patients, renal function should be assessed more frequently and JANUMET
discontinued if evidence of renal impairment is present.

When lactic acidosis occurs, it is fatal in approximately 50% of cases.
The reported incidence of lactic acidosis in patients receiving
metformin is very low (approximately 0.03 cases/1000 patient- years,
with approximately 0.015 fatal cases/1000 patient-years). Reported cases
have occurred primarily in diabetic patients with significant renal
impairment, including both intrinsic renal disease and renal
hypoperfusion, often in the setting of multiple concomitant
medical/surgical problems and multiple concomitant medications.

Patients with congestive heart failure requiring pharmacologic
management, in particular those with unstable or acute congestive heart
failure who are at risk of hypoperfusion and hypoxemia, are at increased
risk of lactic acidosis. The risk of lactic acidosis increases with the
degree of renal dysfunction and the patient’s age. The risk of lactic
acidosis may, therefore, be significantly decreased by regular
monitoring of renal function in patients taking metformin and by use of
the minimum effective dose of metformin. In particular, treatment of the
elderly should be accompanied by careful monitoring of renal function.
Metformin treatment should not be initiated in patients ≥80 years of age
unless measurement of creatinine clearance demonstrates that renal
function is not reduced, as these patients are more susceptible to
developing lactic acidosis. In addition, metformin should be promptly
withheld in the presence of any condition associated with hypoxemia,
dehydration, or sepsis.

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

Alcohol is known to potentiate the effect of metformin on lactate
metabolism. Patients, therefore, should be warned against excessive
alcohol intake, acute or chronic, when receiving JANUMET.

Intravascular contrast studies with iodinated materials can lead to
acute alteration of renal function and have been associated with lactic
acidosis in patients receiving metformin. Therefore, in patients in whom
any such study is planned, JANUMET should be temporarily discontinued at
the time of or before the procedure, withheld for 48 hours subsequent to
the procedure, and reinstituted only after renal function has been
re-evaluated and found to be normal.

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

Use With Medications Known to Cause Hypoglycemia

Sitagliptin

When sitagliptin was used in combination with a sulfonylurea or insulin,
medications known to cause hypoglycemia, the incidence of hypoglycemia
was increased over that of placebo used in combination with a
sulfonylurea or insulin. Therefore, patients also receiving insulin or
an insulin secretagogue (eg, sulfonylurea) may require a lower dose of
insulin or the insulin secretagogue to reduce the risk of hypoglycemia.

The incidence (and rate) of hypoglycemia based on all reports of
symptomatic hypoglycemia were: 16.4% (0.82 episodes/patient-year) for
sitagliptin 100 mg in combination with metformin and glimepiride, 0.9%
(0.02 episodes/patient-year) for placebo in combination with metformin
and glimepiride, 8.2% (0.61 episodes/patient-year) for placebo in
combination with metformin and insulin, and 15.3% (0.98
episodes/patient-year) for sitagliptin in combination with metformin and
insulin.

Adverse reactions with sitagliptin in combination with metformin and
rosiglitazone through Week 18 were: upper respiratory tract infection
(sitagliptin, 5.5%; placebo, 5.2%) and nasopharyngitis (6.1%, 4.1%).
Through Week 54 they were: upper respiratory tract infection
(sitagliptin, 15.5%; placebo, 6.2%), nasopharyngitis (11.0%, 9.3%),
peripheral edema (8.3%, 5.2%), and headache (5.5%, 4.1%).

Metformin hydrochloride

Hypoglycemia does not occur in patients receiving metformin alone under
usual circumstances of use but could occur when caloric intake is
deficient, when strenuous exercise is not compensated by caloric
supplementation, or during concomitant use with other glucose-lowering
agents (such as sulfonylureas and insulin) or ethanol. Elderly,
debilitated, or malnourished patients and those with adrenal or
pituitary insufficiency or alcohol intoxication are particularly
susceptible to hypoglycemic effects.

There have been postmarketing reports of serious hypersensitivity
reactions in patients treated with sitagliptin, one of the components of
JANUMET, 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
sitagliptin, with some reports occurring after the first dose. If a
hypersensitivity reaction is suspected, discontinue JANUMET, 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
JANUMET.

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 of severe joint pain and
discontinue drug if appropriate.

In clinical studies, the most common adverse reactions reported,
regardless of investigator assessment of causality, in ≥5% of patients
treated with either sitagliptin in combination with metformin or placebo
were as follows: diarrhea (7.5% vs 4.0%), upper respiratory tract
infection (6.2% vs 5.1%), and headache (5.9% vs 2.8%). In patients
treated with sitagliptin in combination with metformin and sulfonylurea
or placebo in combination with metformin and sulfonylurea: hypoglycemia
(16.4% vs 0.9%) and headache (6.9% vs 2.7%). In patients treated with
sitagliptin in combination with metformin and insulin or placebo in
combination with metformin and insulin: hypoglycemia (15.3% vs 8.2%).
Other adverse events with an incidence of ≥5% included nasopharyngitis
for sitagliptin monotherapy and diarrhea, nausea/vomiting, flatulence,
abdominal discomfort, indigestion, asthenia, and headache for metformin
therapy.

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
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,
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and YouTube.

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 2014 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.

Please see Prescribing Information for JANUMET^®
(sitagliptin and metformin HCl) at http://www.merck.com/product/usa/pi_circulars/j/janumet/janumet_pi.pdf
and Medication Guide for JANUMET at http://www.merck.com/product/usa/pi_circulars/j/janumet/janumet_mg.pdf.

Merck
Media:
Pam Eisele, +1 (267) 305-3558
Michael Close, +1 (310) 617-1067
or
Investor:
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