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Depomed Unveils Data at the Endocrine Society Meeting Showing Significant Variability Between Generic Metformin Products

Posted on: Thursday, 29 June 2006, 09:00 CDT

Depomed, Inc. (Nasdaq:DEPO) reported results from an in vitro dissolution study that demonstrated statistically significantly different release rates between generic metformin extended release products compared to the currently marketed branded product, Glucophage XR.

The study evaluated the dissolution rates of Glucophage XR compared to six generic manufacturers in an assay performed with modified simulated gastric fluid. The results, which were presented in a poster at the Endocrine Society Annual Meeting held in Boston, demonstrated statistically significant variances in the metformin extended-release products during the first four hours of drug release when approximately 60-70% of the metformin is released. The data highlighted especially large differences in two products when compared to the innovator brand. One product had significantly faster drug release than the comparator (p less than 0.0001) and the other product had a slower release (p less than 0.0001).

Depomed has established a co-promotion agreement with King Pharmaceuticals for the commercialization of Glumetza in the United States, which is targeted for the third quarter of this year. Glumetza is currently marketed in Canada by Biovail Corporation.

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 equal to or greater than 1.5 mg/dL in males and equal to or greater than 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 20 million Americans and its incidence is increasing by approximately one million new cases each year in the U.S. alone. Approximately 90-95% of diabetics suffer from Type 2 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(R) 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) (metformin hydrochloride extended-release tablets)for the treatment of Type 2 diabetes have been approved in the U.S. and Canada. The company is currently conducting a Phase 3 clinical 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 and most recent Quarterly Report on Form 10-Q. 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.

Source: Business Wire

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