Merck Welcomes Independent Review of the Safety Profile of JANUVIA® (sitagliptin) and Other Diabetes Medicines

Wednesday, June 12, 2013 8:00 am EDT

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WHITEHOUSE STATION, N.J.

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NYSE:
MRK
"We are committed to participating in an independent review of our data, and will join the ADA in planning for such an initiative."

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck, known as MSD outside the United States and Canada, today issued the following statement regarding this week's NIDDK-NCI Workshop and the American Diabetes Association’s (ADA) call for an independent review of data about the safety of incretin-based diabetes medicines, including GLP-1 analogs and DPP-4 inhibitors such as JANUVIA® (sitagliptin).

“Nothing is more important to Merck than the safety of our medicines and the people who take them. We welcome opportunities to discuss the data that support the safety profile of sitagliptin in the treatment of adults with type 2 diabetes. Type 2 diabetes is a disease with serious consequences if left untreated,” said Michael Rosenblatt, M.D., chief medical officer, Merck. “We are committed to participating in an independent review of our data, and will join the ADA in planning for such an initiative.”

Merck will participate in the NIDDK-NCI Workshop on Pancreatitis-Diabetes-Pancreatic Cancer that starts today. During the meeting, Merck researchers will present data and the company’s perspective on the safety profile of sitagliptin, including an updated analysis of data in more than 14,000 patients from 25 randomized clinical trials of sitagliptin that was recently published1. Merck has carefully reviewed all of the available safety data from these clinical trials, from our nonclinical studies, post-approval adverse event reports, independent observational studies, and a meta-analysis conducted by an academic research group of published clinical trials with DPP-4 inhibitors involving more than 33,000 patients2. Based on that review, Merck remains confident in the safety profile of sitagliptin.

About JANUVIA® (sitagliptin) 50 mg, 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.

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

Selected Important Risk Information About JANUVIA® (sitagliptin)

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 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 percent (0.59 episodes per patient-year) for JANUVIA 100 mg in combination with glimepiride (with or without metformin), 1.8 percent (0.24 episodes per patient-year) for placebo in combination with glimepiride (with or without metformin), 15.5 percent (1.06 episodes per patient-year) for JANUVIA 100 mg in combination with insulin (with or without metformin), and 7.8 percent (0.51 episodes per 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® (sitagliptin), 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 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 greater than or equal to 5 percent 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

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 consumer care 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, Facebook and YouTube.

Forward-Looking Statement

This news release 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 Merck’s management and are subject to significant risks and uncertainties. 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; Merck’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 Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck 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 Merck’s 2012 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).

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

1 Engel, S. et al. Diabetes Ther. 2013, 4:1

2 Current Medical Research & Opinion Vol. 27, No. S3, 2011, 57–64

JANUVIA® (sitagliptin) is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc..

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