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Merck to Present Phase 3 Data on Investigational Medicines Ertugliflozin and MK-1293 at the 76th Scientific Sessions of the American Diabetes Association

KENILWORTH, N.J.--(BUSINESS WIRE)--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 76th 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 and connect with us on Twitter, Facebook, 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 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.

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