FDA Accepts Merck’s First in Class Drug Application for JANUVIA™ for Type 2

JANUVIA (sitagliptin phosphate)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 when it is elevated.

Merck & Co., Inc. announced that the New Drug Application (NDA) for JANUVIA(TM)* (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.

U.S. drug maker Merck took a lead over Switzerland’s Novartis on Wednesday in the race to get a new class of diabetes treatments approved by U.S. regulators and on the market. The New Jersey-based company said the FDA had accepted its experimental drug Januvia for review, a move that analysts did not expect for up to another year. It means that if approved, Januvia will likely hit the market in October, making it the first in a new and important class of type II diabetes pills called DPP-4 inhibitors.

Mr. Hazlett said the firm’s sales estimates for Januvia now move ahead a year to $25 million in 2006, $400 million in 2007, $850 million in 2008, and $1.3 billion in 2009.

Novartis is also developing a DPP-4 drug called Galvus, which analysts expected the company to file for in the first quarter of this year.

Both companies are expected to discuss their data in June at the meeting of the American Diabetes Association.

JANUVIA is an investigational once-daily medicine with a novel mechanism of action for the treatment of type 2 diabetes. If approved, JANUVIA was not associated with weight gain from baseline, and the incidence of hypoglycemia 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. “

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.

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