MENLO PARK, Calif.--(BUSINESS WIRE)--April 11, 2006--Depomed, Inc. (Nasdaq:DEPO - News) announced today that the results of its Phase III clinical trial with Glumetza(TM), an FDA-approved, once-daily version of metformin for the treatment of Type II diabetes, were published in the April 2006 issue of Diabetes Care. The data demonstrated that Glumetza (extended-release metformin) controlled glucose levels in all key glycemic measures at least as effectively as immediate-release metformin and demonstrated excellent tolerability. Importantly, the data showed the most effective glycemic control was achieved with the once-daily 2,000 mg dose of Glumetza.
“Metformin is a commonly prescribed first-line treatment for patients with Type II diabetes, with over 42 million prescriptions written in 2005 that generated $1.4 billion in sales,” said Bret Berner, Ph.D., vice president, Product Development and chief scientific officer of Depomed. “We feel that Glumetza provides a unique formulation of metformin that increases the potential of what this drug can offer. Glumetza leverages Depomed’s AcuForm(TM) drug delivery technology, which is designed to enhance tolerability and reduce the gastrointestinal side effects associated with oral medications.”
The paper, entitled “Efficacy, Tolerability, and Safety of a Novel Once-Daily Extended-Release Metformin in Patients with Type 2 Diabetes” (Sherwyn Schwartz, M.D., et al), summarized the data gathered during a randomized, double-blind Phase III clinical trial comparing treatment with Glumetza to immediate-release metformin in patients with Type II diabetes. Patients were randomized to receive one of four treatment options: Glumetza 1,500 mg once daily, Glumetza 1,500 mg twice daily, Glumetza 2,000 mg once daily, or immediate-release metformin 1,500 mg twice daily. All four patient groups demonstrated significant reductions in HbA1C, a common measure of glucose levels (p less than 0.001). There were no significant differences in efficacy among the four groups, although fewer patients discontinued treatment due to lack of efficacy in the 2,000 mg Glumetza group than in the immediate-release metformin group (1.8% versus 8.0%, p=0.007).
“Most physicians want to see their patients achieve a 2,000 mg dose of metformin, with the minimal target dose of 1,500 mg,” said Dr. Sherwyn Schwartz, endocrinologist, lead author on the paper, and a principal investigator in the Phase III clinical trials of Glumetza. “Side effects such as nausea and diarrhea are thought to be a primary reason that more than half of all patients don’t achieve the target dose of metformin needed to control their blood glucose and are no longer taking their medication as prescribed after the first year. Following this Phase III clinical trial, patients were switched to the 2,000 mg once-daily dose of Glumetza for 24 weeks, and we observed successful maintenance of blood glucose levels and a 97.2% rate of adherence to the therapeutic regimen as prescribed.”
Glumetza is currently marketed in Canada by Biovail Corporation. Depomed is in negotiations with several companies regarding promotion rights in the U.S. and has licensed Korean commercialization rights to LG Life Sciences.
About Glumetza(TM)
Glumetza(TM) is a once-daily, extended-release formulation of metformin HCl indicated as an adjunct to diet and exercise to improve glycemic control in adult patients (18 years and older) with type 2 diabetes. Glumetza may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults.
Glumetza is contraindicated in patients with renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels greater than or equal to 1.5 mg/dL in males and greater than or equal to 1.4 mg/dL in females), congestive heart failure, known hypersensitivity to metformin HCl, and acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. As with all metformins, there is a warning regarding lactic acidosis with Glumetza. For additional information on the product, please access the package insert at http://www.depomedinc.com/Glumetza_Prescribing_Info.pdf.
About Diabetes
Diabetes affects an estimated 18 million Americans and is increasing by approximately one million new cases each year in the U.S. alone. Approximately 90% of diabetics suffer from Type II diabetes, the most common metabolic disease in the world and the fifth-deadliest disease in the U.S. Diabetes is the leading cause of blindness, end-stage renal disease and non-traumatic loss of limb and can also lead to heart disease, stroke, high blood pressure, kidney disease and other serious conditions. In the U.S., the public health cost of diabetes is more than $130 billion per year.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative AcuForm(TM) drug delivery technology to develop novel oral products and improved, extended release formulations of existing oral drugs. AcuForm-based products are designed to provide once daily administration and reduced side effects, improving patient convenience, compliance and pharmacokinetic profiles. ProQuin® XR (ciprofloxacin hydrochloride) once daily, extended-release tablets have been approved by the FDA for the treatment of uncomplicated urinary tract infections. In addition, regulatory applications for once daily Glumetza(TM) for the treatment of Type II diabetes have been approved in the U.S. and Canada. The company completed a Phase II trial in postherpetic neuralgia with its product, Gabapentin GR. Additional information about Depomed may be found at its web site, www.depomedinc.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to those related to our commercialization efforts and those of our collaborative partners, our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-K. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Contact: Depomed, Inc. Sylvia Wheeler, 650-462-5900
Source: Depomed, Inc.
