Healthcare Industry News: Biovail
News Release - April 2, 2007
Depomed Files Prior Approval Supplement for 1000 mg Strength Tablets of GlumetzaMENLO PARK, Calif.--(HSMN NewsFeed)--Depomed, Inc. (NASDAQ:DEPO ) announced today that it has filed a prior approval supplement with the U.S. Food and Drug Administration (FDA) seeking approval to market in the United States 1000 mg strength tablets of Glumetza(TM)(metformin hydrochloride extended release tablets). The company expects the FDA to make a determination on the filing before the end of the third quarter of this year.
"This filing takes us one step closer to making the management of type 2 diabetes more convenient for adults who prefer to take fewer tablets each day," stated Carl Pelzel, executive vice president and chief operating officer of Depomed. "We hope to obtain marketing approval for the 1000 mg tablets later this year and to make them commercially available in the United States soon thereafter."
The new formulation, which Biovail was in the process of formulating when Depomed acquired rights to the product in December 2005, would replace the 1000 mg strength tablet currently covered by the Glumetza New Drug Application. The supplement filed with the FDA includes data from a comparative bioavailability study demonstrating that the 1000 mg strength tablets achieved equivalent peak and systemic exposure when compared to Glumetza 500 mg tablets given as two tablets under single-dose fed conditions. No serious adverse events were reported.
Diabetes affects an estimated 20 million Americans and its incidence is increasing by approximately 1 million new cases each year in the United States alone. Approximately 90 percent to 95 percent of people with diabetes suffer from type 2 diabetes, the most common metabolic disease in the world and the fifth deadliest disease in the United States. Diabetes is the leading cause of blindness, end-stage renal disease, and non-traumatic loss of limb. It can also lead to heart disease, stroke, high blood pressure, kidney disease, and other serious conditions. In the United States, the public health cost of diabetes is more than $130 billion per year. In August 2006, the American Diabetes Association and the European Association for the Study of Diabetes issued a consensus statement recommending that treatment with metformin be initiated at diagnosis along with lifestyle changes in patients with type 2 diabetes.
Glumetza(TM) (metformin hydrochloride 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 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), 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 boxed warning regarding lactic acidosis with Glumetza due to metformin accumulation during treatment. Lactic acidosis 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 or older. In clinical trials of Glumetza combined with a sulfonylurea, the most common side effects included hypoglycemia, diarrhea, and nausea. For additional information on the product, please access the prescribing information at www.glumetzaxr.com .
Depomed, Inc., is a specialty pharmaceutical company with two approved products on the market and multiple product candidates in its pipeline. The company utilizes its proven, proprietary AcuForm(TM) drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Glumetza(TM) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is being marketed in the United States by King Pharmaceuticals and in Canada by Biovail Corporation. ProQuin® XR (ciprofloxacin hydrochloride) extended release tablets are approved in the United States for the once-daily treatment of uncomplicated urinary tract infections and is marketed by Esprit Pharma. Product candidate Gabapentin GR(TM) is currently in Phase 3 and Phase 2 clinical development for the treatment of two pain indications, postherpetic neuralgia and diabetic peripheral neuropathy, respectively. A Phase 2 clinical trial of Gabapentin GR in menopausal hot flashes is expected to begin in the second quarter of 2007. Additional information about Depomed may be found on its web site, www.depomedinc.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. The inclusion of forward-looking statements, including those related to FDA review of our GLUMETZA 1000 mg prior approval supplement, and anticipated benefits of the 1000 mg formulation of GLUMETZA, should not be regarded as a representation that any of our plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation, risks and uncertainties related to: 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; our ability to successfully commercialize our products; the success of our collaborative arrangements with development and commercialization partners; and other risks detailed in our filings with the Securities and Exchange Commission filings, including our most recent 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. We undertake no obligation to revise or update this release to reflect events or circumstances that occur after the date of this release.
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