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May 16, 2017 7:00 am ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that 19 scientific presentations from Merck’s diabetes
pipeline and portfolio – including Phase 3 data for investigational
ertugliflozin, additional analyses of JANUVIA^® (sitagliptin),
and real-world research – will be presented at the 77^th
Scientific Sessions of the American Diabetes Association (ADA) in San
Diego, June 9-13, 2017. Oral and poster presentations of ertugliflozin,
a SGLT-2 inhibitor in development with Pfizer, include new data from two
Phase 3 studies and 52-week extension data from three other studies in
the VERTIS clinical development program.

“Merck’s commitment to advancing the care of patients with diabetes
continues in full force. At this year’s ADA, we look forward to sharing
new clinical data with the scientific community that provide further
insights into our established and investigational medicines for type 2
diabetes, and results of real-world studies on important type 2
diabetes-related topics such as hypoglycemia and clinical inertia,” said
Sam Engel, M.D., associate vice president of cardiometabolic and women’s
health, Merck Research Laboratories.

Abstracts

Select abstracts to be presented include the following:

Ertugliflozin

• Safety and efficacy of ertugliflozin plus sitagliptin vs. either
  treatment alone after 52 weeks in subjects with T2DM inadequately
  controlled on metformin: VERTIS FACTORIAL trial extension (Abstract
  #130-OR; Saturday, June 10, 4:15-4:30 p.m. PDT)
• Safety and efficacy of ertugliflozin after 52 weeks in subjects with
  T2DM inadequately controlled on metformin and sitagliptin: Results
  from the extension phase of the VERTIS SITA2 trial (Abstract #133-OR;
  Saturday, June 10, 5:00-5:15 p.m. PDT)
• Effect of ertugliflozin on glycemic control, body weight, blood
  pressure (BP) and bone density (BMD) in T2DM inadequately controlled
  with metformin monotherapy: VERTIS MET trial (Abstract #1168-P;
  General Poster Session: Sunday, June 11, 12:00-1:00 p.m. PDT;
  Moderated Poster Session: Monday, June 12, 12:00-1:00 p.m. PDT)
• Safety and efficacy of ertugliflozin in combination with sitagliptin
  in subjects with T2DM inadequately controlled on diet and exercise:
  The VERTIS SITA trial (Abstract #1197-P; Sunday, June 11, 12:00-1:00
  p.m. PDT)
• Long-term efficacy and safety of ertugliflozin monotherapy in patients
  with inadequately controlled T2DM despite diet and exercise: The
  52-week VERTIS MONO study (Abstract #1208-P; Sunday, June 11,
  12:00-1:00 p.m. PDT)

JANUVIA

^®

(sitagliptin)

• Efficacy and safety of sitagliptin in subjects with T2DM and
  depression using antidepressant medications (Abstract #1309-P;
  Saturday, June 10, 11:30 a.m.-12:30 p.m. PDT)
• Time to insulin in the Trial Evaluating Cardiovascular Outcomes with
  Sitagliptin (TECOS) (Abstract #1183-P; Sunday, June 11, 12:00-1:00
  p.m. PDT)
• Efficacy and safety of sitagliptin in Hispanic subjects with T2DM
  (Abstract #1207-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
• Emerging sitagliptin benefit for all-cause hospitalizations: Evidence
  from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin
  (TECOS) (Abstract #1344-P; Sunday, June 11, 12:00-1:00 p.m. PDT)

Real-World Data – Type 2 Diabetes

• The relationship between hypoglycemia severity and health-related
  quality of life among U.S. patients with type 2 diabetes (Abstract
  #397-P; Saturday, June 10, 11:30 a.m.-12:30 p.m. PDT)
• Trends in glycemic medications and control in youths with type 2
  diabetes (T2D): The SEARCH for diabetes in youth study (Abstract
  #176-OR; Sunday, June 11, 9:30-9:45 a.m. PDT)
• Reduced burden of hypoglycemia related to dipeptidyl peptidase-4
  inhibitor use (Abstract #3-LB; Sunday, June 11, 12:00-1:00 p.m. PDT)
• Factors associated with clinical inertia after metformin monotherapy
  failure (Abstract #1212-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
• Impact of a sitagliptin step-therapy program on diabetes medication
  use (Abstract #1331-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
• Comorbidity prevalence among patients with established cardiovascular
  disease and type 2 diabetes (Abstract #1509-P; Sunday, June 11,
  12:00-1:00 p.m. PDT)
• Insulin initiation among patients with type 2 diabetes mellitus and
  discontinuation of sulfonylureas (Abstract #1677-P; Sunday, June 11,
  12:00-1:00 p.m. PDT)
• Impact of timely treatment intensification on glycemic goal
  achievement in patients with type 2 diabetes failing metformin
  (Abstract #1726-P; Sunday, June 11, 12:00-1:00 p.m. PDT)
• Drug copay and medication adherence in Medicare patients with type 2
  diabetes (Abstract #279-OR; Monday, June 12, 8:30-8:45 a.m. PDT)
• Impact of switching to a high-deductible health plan on diabetes
  treatment discontinuation (Abstract #280-OR; Monday, June 12,
  8:45-9:00 a.m. PDT)

For more information, including a complete list of abstract titles at
the meeting, please visit: http://www.abstractsonline.com/pp8/#!/4297/.

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.

Assessment of renal function is recommended prior to initiating JANUVIA
(sitagliptin) 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.

Postmarketing cases of bullous pemphigoid requiring hospitalization have
been reported with DPP-4 inhibitor use. In reported cases, patients
typically recovered with topical or systemic immunosuppressive treatment
and discontinuation of the DPP-4 inhibitor. Tell patients to report
development of blisters or erosions while receiving JANUVIA
(sitagliptin). If bullous pemphigoid is suspected, JANUVIA should be
discontinued and referral to a dermatologist should be considered for
diagnosis and appropriate treatment.

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 more than a century, Merck, a leading global biopharmaceutical
company known as MSD outside of the United States and Canada, has been
inventing for life, bringing forward medicines and vaccines for many of
the world’s most challenging diseases. 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. Today, Merck continues to be at the forefront of
research to advance the prevention and treatment of diseases that
threaten people and communities around the world – including cancer,
cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease
and infectious diseases including HIV and Ebola. For more information,
visit www.merck.com
and connect with us on Twitter, Facebook, Instagram,
YouTube
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 2016 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
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Kristen Drake, 908-740-6179
or
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