Type 2 Diabetes - Merck Announces FDA Acceptance Of New Drug Application For JANUVIA(R), The Company's Investigational Medicine

Main Category: Diabetes
Article Date: 20 Feb 2006 - 10:00 PDT

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Merck & Co., Inc. announced that the New Drug Application (NDA) for JANUVIA(R)* (sitagliptin phosphate) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck expects FDA action on the NDA by mid-October. The Company also is moving forward as planned with filings in countries outside the United States.

JANUVIA is an investigational once-daily medicine with a novel mechanism of action for the treatment of type 2 diabetes. If approved, JANUVIA would potentially be the first in a new class of oral medications (DPP-4 inhibitors) that enhances the body's own ability to lower blood sugar (glucose) when it is elevated. In clinical studies, JANUVIA was not associated with weight gain from baseline, and the incidence of hypoglycemia (when blood sugar becomes too low) was similar to placebo. The most common side effects reported in clinical studies with JANUVIA were stuffy or runny nose and sore throat; headache; diarrhea; and joint pain.

"Based on our clinical studies, we believe JANUVIA represents a new and different approach to the treatment of type 2 diabetes," said Richard T. Clark, chief executive officer and president, Merck & Co., Inc. "Merck is committed to developing innovative therapies that offer advances in the treatment of serious diseases like diabetes and demonstrate clear value to patients, payors and physicians."

"The discovery and development of JANUVIA is a prime example of our Company's strategy to target key therapeutic areas, such as diabetes," said Dr. Peter S. Kim, president, Merck Research Laboratories. "The filing of JANUVIA demonstrates the ability of our research labs to efficiently develop innovative medicines, while also maintaining our strong commitment to patient safety and scientific excellence."

About JANUVIA

JANUVIA is Merck's investigational oral dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes.

DPP-4 inhibitors work by enhancing a natural body system that lowers blood sugar, the incretin system. When blood sugar is elevated, incretins work in two ways to help the body regulate high blood sugar levels: they trigger the pancreas to increase insulin and signal the liver to stop producing glucose. DPP-4 inhibitors enhance the body's own ability to control blood sugar levels by increasing the active levels of these incretin hormones in the body, helping to decrease blood sugar levels in patients with type 2 diabetes.

About Type 2 Diabetes

Type 2 diabetes is a condition in which the body has elevated blood sugar or glucose. With type 2 diabetes, the body may not make enough insulin (which helps the body use glucose), the insulin that the body produces may not work as well as it should, or the body may make too much glucose. Patients with diabetes can develop heart disease, kidney disease, blindness, vascular or neurological problems that can lead to amputation and they can suffer increased mortality.

Nearly 21 million people in the United States, or seven percent of the population, have diabetes, with type 2 diabetes accounting for 90 to 95 percent of the cases. Less than 50 percent of adults with diagnosed diabetes achieve the American Diabetes Association target level of glucose control (A1C less than seven percent). It is estimated that one in three Americans born in 2000 will develop diabetes sometime during their lifetime. There are currently more than 194 million people with diabetes worldwide, and if nothing is done to slow the epidemic, the number will exceed to 333 million by 2025.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Forwarding-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.

*JANUVIA(R) is the proposed trademark for MK-431 (sitagliptin phosphate).

http://www.merck.com