Healthcare Industry News: Gabapentin GR
News Release - August 23, 2006
Depomed and King Pharmaceuticals Prepare for Launch of Glumetza(TM) as Timely, New ADA Guidelines Are IssuedConsensus Statement Recommends That Metformin Be Added to Lifestyle Changes as Initial Treatment for Type 2 Diabetes
MENLO PARK, Calif. & BRISTOL, Tenn.--(HSMN NewsFeed)--Aug. 23, 2006--Depomed, Inc. (NASDAQ:DEPO ) and King Pharmaceuticals, Inc. (NYSE:KG ) announced today that as they prepare for the launch of Glumetza(TM) (metformin hydrochloride extended-release tablets), a new consensus statement was issued from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). The statement recommends that treatment with metformin be initiated at diagnosis along with lifestyle changes in patients with type 2 diabetes. In the absence of specific contraindications, metformin is recommended because of its effect on glycemia and absence of weight gain, among other benefits. The consensus statement was published in the August 2006 issue of Diabetes Care.(1)
"These new guidelines were created to define a clear pathway of treatment when physicians are managing diabetes, given the many new and existing therapeutic options and combinations available," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "The ADA's recommendation to start treating diabetic patients with metformin at the point of diagnosis prioritizes this agent as a first line of defense in controlling hyperglycemia. In addition, it recognizes that, unfortunately, most people with type 2 diabetes fail to achieve or maintain their metabolic goals utilizing lifestyle interventions alone. Depomed applauds the ADA's move to address this problem with a recommendation for more aggressive treatment to quickly get glycemic levels under control in order to lessen the long-term health complications and costs associated with this disease."
The ADA and EASD recommendation is based on findings from several clinical trials evaluating various treatments for type 2 diabetes. The results of these trials indicate that present-day diabetes management does not result in successful maintenance of glycemia, as measured by HbA1C levels of less than 7%. The study authors thus presented new guidelines and a treatment algorithm recommending the initiation of both lifestyle changes and metformin treatment at diagnosis. The study notes that metformin has been shown to lower HbA1C levels by approximately 1.5 percentage points and that the most common side effects are gastrointestinal in nature.
Dr. Sherwyn Schwartz, Medical Director, Diabetes and Glandular Disease Clinic, commented, "I am encouraged by the new ADA recommendation regarding the use of metformin at diagnosis. When I served as an investigator in a Phase III clinical trial of Glumetza(TM), an extended-release version of metformin, we observed successful maintenance of blood glucose levels and a 97.2% rate of adherence to the therapeutic regimen as prescribed during the open-label follow-on study in which all patients received 2,000 mg of once-daily Glumetza for 24 weeks."(2)
Depomed and King are currently preparing for a launch for Glumetza(TM) in the coming weeks. Glumetza(TM) is a novel formulation of metformin that uses Depomed's AcuForm(TM) drug delivery technology to provide physicians with a new option for helping their type 2 diabetes patients achieve their HbA1C goals.
"Although there are now more options than ever before in the treatment of diabetes, this consensus statement demonstrates that metformin plays a vital role," Dr. Fara added. "We look forward to launching Glumetza(TM) with King next month, and we believe it increases the potential of what metformin can offer and will help physicians and patients achieve their glycemic control goals."
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(TM) may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults.
Glumetza(TM) 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 warning regarding lactic acidosis with Glumetza(TM) 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 greater than or equal to 80 years of age. 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 package insert at http://www.depomedinc.com/glumetza_Prescribing_Info.pdf.
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.
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) extended-release tablets have been approved by the FDA for the once daily treatment of uncomplicated urinary tract infections and are currently being marketed in the United States. In addition, once daily Glumetza(TM) (metformin hydrochloride extended release tablets) has been approved for use in adults with type 2 diabetes and is currently being marketed in Canada. The company is conducting a Phase III trial in postherpetic neuralgia with its product candidate, Gabapentin GR(TM). Additional information about Depomed may be found at its web site, www.depomedinc.com.
About King Pharmaceuticals
King Pharmaceuticals, Inc., headquartered in Bristol, Tennessee, is a vertically integrated pharmaceutical company that develops, manufactures, markets and sells branded prescription pharmaceutical products. King Pharmaceuticals, Inc., an S&P 500 Index company, seeks to identify promising opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.
"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 diabetes care, the launch of Glumetza(TM), research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; and the timing of regulatory applications and product launches. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of Depomed's Form 10-K for the year ended December 31, 2005 and Form 10-Q for the second quarter ended June 30, 2006, and King's Form 10-K for the year ended December 31, 2005 and Form 10-Q for the second quarter ended June 30, 2006, which are on file with the U.S. Securities and Exchange Commission. The companies do not undertake to publicly update or revise any of their forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.
(1) Nathan D, et al.: Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy. Diabetes Care volume 29 number 8: 1963-1972, 2006
(2) Schwartz S, et al.: Efficacy, Tolerability, and Safety of a Novel Once-Daily Extended-Release Metformin in Patients with Type 2 Diabetes. Diabetes Care volume 29 number 4: (759-764), 2006
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