Glumetza® for Type 2 Diabetes

GLUMETZA® (metformin HCl extended release tablets) is a once-daily, extended release formulation of metformin for the treatment of adults with type 2 diabetes.*

Formulated with AcuForm™ delivery technology, Glumetza is delivered over a nine-hour period to the upper gastrointestinal (GI) tract. This controlled, targeted delivery enables rapid titration to an effective dose with once-a-day dosing.

Glumetza was approved in the United States on June 3, 2005 and in Canada on May 31, 2005.

Improving the Standard of Care for Diabetes 

Data from clinical studies of 2000 mg of once-daily Glumetza demonstrate the patient benefits made possible with AcuForm formulation:

Excellent Efficacy: In an intent-to-treat analysis, 60.4 percent of patients on once-daily Glumetza 2000 mg monotherapy achieved the American Diabetes Association (ADA) A1C goal of <7.0 percent.

Increased Tolerability: Patients given Glumetza 2000 mg once-daily vs. immediate release metformin given 1500 mg divided daily dose reported no increase in adverse events.

Outstanding Compliance: 97.2 percent of patient adhered to Glumetza 2000 mg once-daily in a 24-week, open-label extension study.

Addressing a Large Patient Population

According to the ADA, an estimated 14.6 million individuals in the United States have been diagnosed with diabetes, of which approximately 90 percent to 95 percent are estimated to have type 2 diabetes. In 2006, prescriptions for metformin totaled approximately 49 million, making it the top-prescribed drug in the United States. Over the past five years, prescriptions for metformin have increased approximately 15 percent each year.

Commercialization and Partnering Update

U.S. commercialization of Glumetza commenced in September 2006.  Depomed is seeking a marketing partner in the U.S.

Outside of the United States, Glumetza is marketed in Canada by Biovail Corporation (NYSE:BVF)(TSX:BVF), and in Korea by LG Life Sciences. Depomed is actively seeking commercialization partners for European territories.

Indication and Important Safety Information

* GLUMETZA® (metformin HCL extended release tablets) is indicated alone or in combination with sulfonylurea or insulin as an adjunct to diet and exercise to improve glycemic control in patients 18 years of age and older with type 2 diabetes.

As with all metformin products, lactic acidosis due to metformin accumulation during treatment with GLUMETZA® is a rare but potentially fatal occurrence. It may also occur in association with a number of pathophysiologic conditions. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age, especially patients ≥ 80 years of age. The risk of lactic acidosis while on GLUMETZA® therapy may be significantly decreased by initial and regular monitoring of renal and liver function; using the minimum effective dose; withholding in the presence of any condition associated with hypoxemia, dehydration, or sepsis; avoidance in patients with hepatic disease; cautioning patients against excessive alcohol intake; temporarily discontinuing prior to any intravascular radiocontrast study or surgical procedure. Lactic acidosis is a medical emergency requiring immediate discontinuation of GLUMETZA®; general supportive measures and prompt hemodialysis are recommended to correct the acidosis and remove the accumulated metformin.

GLUMETZA® is contraindicated in patients with renal dysfunction, known hypersensitivity to metformin HCl or metabolic acidosis, including diabetic ketoacidosis. Use of concomitant medications that affect renal function or hemodynamic change may interfere with the disposition of metformin and should be used with caution. Hypoglycemia does not occur in patients receiving GLUMETZA® alone but could occur in deficient caloric intake or during concomitant use with other glucose-lowering agents or ethanol. Loss of glycemic control may occur when a stabilized patient is exposed to stress. In clinical trials, of GLUMETZA® combined with a sulfonylurea, the most common side effects included hypoglycemia, diarrhea, and nausea.