NJ-MSD

MSD, known as Merck (NYSE:MRK) in the United States and Canada, today announced that omarigliptin, MSD’s investigational once-weekly DPP-4 inhibitor in development for adults with type 2 diabetes, achieved its primary efficacy endpoint in a Phase 3 study. Omarigliptin was found to be non-inferior to MSD’s once-daily DPP-4 inhibitor, JANUVIA^® (sitagliptin), at reducing patients’ HbA1c* levels from baseline, with similar HbA1c reductions achieved in both groups. The head-to-head study was designed to evaluate once-weekly treatment with omarigliptin 25 mg compared to 100 mg of JANUVIA once daily, a widely prescribed DPP-4 inhibitor worldwide. Results were presented during an oral session at the 51^st European Association for the Study of Diabetes (EASD) Annual Meeting.¹

“Type 2 diabetes is a chronic, progressive disease that affects approximately 387 million people worldwide² , and this number continues to grow rapidly. Many people are still not at their recommended blood sugar levels, underscoring the importance of individualized blood sugar goals and multiple treatment options,” said Sam Engel, M.D., associate vice president, Merck clinical research, diabetes and endocrinology. “Omarigliptin has the potential to be an important treatment option, particularly for those who also prefer once-weekly dosing.”

MSD submitted a new drug application to the Japanese Pharmaceuticals and Medical Devices Agency in November 2014 and plans to submit for regulatory approval of omarigliptin in the United States by the end of 2015. The clinical development program for omarigliptin, O-QWEST (O marigliptin Q W eekly E fficacy and S afety in T ype 2 Diabetes), includes 10 Phase 3 clinical trials involving approximately 8,000 patients with type 2 diabetes.

About the study

This Phase 3 randomized, double-blind, non-inferiority trial assessed the efficacy, safety and tolerability of omarigliptin 25 mg once weekly compared to JANUVIA 100 mg once daily in adults with type 2 diabetes (n=642) who experienced inadequate glycemic control while taking metformin. The primary efficacy endpoint was non-inferiority of omarigliptin to JANUVIA in decreasing HbA1c levels from baseline to week 24.¹ At the start of the trial, baseline HbA1c was approximately 7.5 percent in both groups. Mean baseline fasting plasma glucose (FPG) levels were also similar between treatment groups.

The study achieved its primary efficacy endpoint of non-inferior reductions in HbA1c for omarigliptin compared to JANUVIA at 24 weeks.¹ At week 24, patients taking omarigliptin had an average HbA1c reduction from baseline of -0.47 percent as compared to an average reduction of -0.43 percent among patients taking JANUVIA, with a difference of -0.03 between groups (95% CI [-0.15, 0.08]). In patients in the pre-specified sub-group with a higher baseline HbA1c of greater than or equal to 8.0 percent, omarigliptin treatment resulted in reductions of -0.79 percent compared to -0.71 percent for JANUVIA (difference = -0.08 percent; 95% CI [-0.37, 0.21]).

The percentage of patients achieving their HbA1c goals was similar for both omarigliptin and JANUVIA. At 24 weeks, 51 percent of patients treated with omarigliptin reached an HbA1c of less than 7.0 percent, compared to 49 percent of patients treated with JANUVIA (p=0.334). The percentage of patients reaching an HbA1c of less than 6.5 percent was also similar across treatment groups: 27 percent for omarigliptin compared with 23 percent for JANUVIA (p=0.219). FPG was reduced from baseline by 0.8 mmol/L in the omarigliptin group and 0.5 mmol/L in the JANUVIA group, with a between-group difference of -0.2 mmol/L (p= 0.089).¹

The incidences of serious adverse events, drug-related adverse events and discontinuations were similar across both treatment groups. Common adverse events included diarrhea (0.9 percent for omarigliptin vs. 2.8 percent for JANUVIA), influenza (0.3 percent for omarigliptin vs. 2.2 percent for JANUVIA), upper respiratory tract infection (4.0 percent for omarigliptin vs. 3.8 percent for JANUVIA), urinary tract infection (1.2 percent for omarigliptin vs. 2.8 percent for JANUVIA), lipase increase (2.5 percent for omarigliptin vs. 4.1 percent for JANUVIA) and back pain (2.5 percent for omarigliptin vs. 0.6 percent for JANUVIA). Adverse events of hypoglycemia (symptomatic and asymptomatic) were reported in 3.7 percent of the omarigliptin group (with one severe hypoglycemia event reported) and 4.7 percent of the JANUVIA group.¹

About JANUVIA ^®

JANUVIA^® is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus as monotherapy when metformin is inappropriate due to contraindications or intolerance or in combination with metformin, a sulfonylurea, or a PPARγ agonist, or as an add-on to sulfonylurea + metformin or PPARγ agonist + metformin when the current regimen, with diet and exercise does not provide adequate glycemic control. JANUVIA is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycemic control.

Important Selected Safety Information About Sitagliptin

JANUVIA is contraindicated in patients who are hypersensitive to any components of this product. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUVIA. Because these reports are made voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of JANUVIA. If pancreatitis is suspected, JANUVIA and other potentially suspect medicinal products should be discontinued. A dosage adjustment is recommended in patients with moderate or severe renal insufficiency or with end-stage renal disease requiring hemodialysis or peritoneal dialysis.

As with other antihyperglycemic agents, when JANUVIA was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, the incidence of sulfonylurea- or insulin-induced hypoglycemia was increased over that of placebo. To reduce the risk of sulfonylurea- or insulin-induced hypoglycemia, a lower dose of sulfonylurea or insulin may be considered.

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA including anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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.

In clinical studies as monotherapy and in combination with other agents, the adverse experiences reported regardless of causality assessment in ≥5% of patients and more commonly than placebo or the active comparator included hypoglycemia, nasopharyngitis, upper respiratory tract infection, headache, and peripheral edema.

For additional adverse experience information, see the product circular.

In clinical studies, the safety and effectiveness of JANUVIA in the elderly (≥65 years) were comparable to those seen in patients <65 years. No dosage adjustment is required based on age. In elderly patients with significant renal insufficiency dosage adjustment may be required.

Before initiating therapy, please consult the full prescribing information.

MSD commitment to diabetes

At MSD, we are committed to improving type 2 diabetes care through scientific advancement and innovation for the millions of people living with diabetes every day. We strive to deliver a broad range of treatments and educational tools for patients and healthcare providers and are applying significant resources and capabilities with a continued focus on research and development.

About MSD

Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. 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.

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

This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the “company”) 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 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 healthcare legislation in the United States and internationally; global trends toward healthcare 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 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 ).

References

¹ Gantz, I et al. Omarigliptin, a once-weekly DPP-4 inhibitor, provides similar glycaemic control to sitagliptin in patients with type 2 diabetes mellitus inadequately controlled on metformin. Presentation No. 110, to be presented at the 51st EASD Annual Meeting on Sept.16, 2015. Available at: http://www.easdvirtualmeeting.org/resources/omarigliptin-a-once-weekly-dpp-4-inhibitor-provides-similar-glycaemic-control-to-sitagliptin-in-patients-with-type-2-diabetes-mellitus-inadequately-controlled-on-metformin--2. Last accessed Sept. 2015 .

² IDF. IDF Diabetes Atlas, Sixth Edition, 2014 Update. 2014. Available at: https://www.idf.org/sites/default/files/Atlas-poster-2014_EN.pdf

*HbA1c is an estimate of a person's average blood glucose over a two- to three-month period.

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