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MSD to Present New Clinical Data on Sitagliptin, Investigational Omarigliptin, and Real-World Data in Patients with Type 2 Diabe
Associated Press
2014-06-06 08:22 PM

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jun 6, 2014--MSD, known as Merck (NYSE:MRK) in the United States and Canada, will present 13 new studies and analyses, including data for its DPP-4 inhibitor JANUVIA R (sitagliptin) and for its investigational once-weekly DPP-4 inhibitor omarigliptin, at the 74th Scientific Sessions of the American Diabetes Association (ADA) being held in San Francisco, June 13-17, 2014.

Several analyses of patient outcomes in real-world settings will also be presented.

"Merck is dedicated to helping patients with diabetes and transforming the way diabetes is managed throughout the world, as a part of our commitment to being a global leader in diabetes care," said Peter Stein, M.D., vice president of Clinical Research for diabetes and endocrinology, Merck Research Laboratories. "We are pleased to share new data on our diabetes portfolio and pipeline."

Abstracts to be presented include:

About JANUVIA

R

(sitagliptin)

JANUVIA? is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus as initial therapy, alone or in combination with metformin, or a PPAR?^ agonist, or as an add-on to metformin, PPAR?^ agonist, sulfonylurea, sulfonylurea + metformin or PPAR?^ agonist + metformin when the current regimen, with diet and exercise does not provide adequate glycemic control. JANUVIA can also be used as an adjunct to diet and exercise to improve glycemic control in combination with insulin (with or without metformin).

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.

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 Whitehouse Station, N.J., U.S.A. 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, please visit www.msd.com.

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 MSD'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; MSD'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.

MSD 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 MSD's/Merck's 2013 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 ).

JANUVIA

R

is a registered trademark of MSD, a subsidiary of Merck & Co., Inc.

CONTACT: MSD

Media:

Michael Close, +1-267-305-1211

Pam Eisele, +1-908-423-5042

Investors:

Carol Ferguson, +1-908-423-4465

KEYWORD: UNITED STATES EUROPE ASIA PACIFIC NORTH AMERICA CALIFORNIA NEW JERSEY

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY PHARMACEUTICAL RESEARCH DIABETES SCIENCE

SOURCE: MSD

Copyright Business Wire 2014

PUB: 06/06/2014 08:00 AM/DISC: 06/06/2014 08:00 AM

http://www.businesswire.com/news/home/20140606005066/en

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