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New Once-Daily Oral Diabetes Treatment Glumetza(TM) Now Available.


BRISTOL, Tenn. & MENLO PARK, Calif. -- - Novel Drug-Delivery Technology Enables Extended-Release Formulation to Combine Efficacy Benefits of Metformin metformin /met·for·min/ (met-for´min) an antihyperglycemic agent that potentiates the action of insulin, used in the treatment of type 2 diabetes mellitus.

met·for·min
n.
 with Once-Daily Dosing to Maximize Metformin Therapy -

Adult patients living with type 2 diabetes type 2 diabetes
n.
See diabetes mellitus.
 now have a new treatment option available that may help them get the most out of their care. King Pharmaceuticals, Inc. (NYSE NYSE

See: New York Stock Exchange
: KG) and Depomed, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: DEPO DEPO Delegated Episcopal Pastoral Oversight
DEPO Devils Postpile National Monument (US National Park Service)
DEPO Defence Export Promotion Organization (Pakistan)
DEPO Double Even Pass Odd
) today announced the commercial availability of Glumetza(TM) (metformin hydrochloride metformin hydrochloride Warning - High-alert drug!

Apo-Metformin (CA), Fortamet, Glucophage, Glucophage XR, Glycon (CA), Metsol (UK), Novo-Metformin (CA), Riomet

Pharmacologic class:
 extended release tablets) in the United States. Glumetza, an oral treatment for type 2 diabetes, offers the benefits of metformin, including reliable glycemic Glycemic
The presence of glucose in the blood.

Mentioned in: Cholesterol, High


glycemic

pertaining to the level of glucose in the blood.
 control, absence of weight gain, and a low incidence of hypoglycemia hypoglycemia: see diabetes.
hypoglycemia

Below-normal levels of blood glucose, quickly reversed by administration of oral or intravenous glucose. Even brief episodes can produce severe brain dysfunction.
, with the added convenience of once-daily dosing. Glumetza tablets utilize patented AcuForm(TM) technology, a novel drug-delivery system that provides controlled and prolonged release of metformin. Metformin is the only medication recommended by the American Diabetes Association The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of  (ADA Ada, city, United States
Ada (ā`ə), city (1990 pop. 15,820), seat of Pontotoc co., S central Okla.; inc. 1904. It is a large cattle market and the center of a rich oil and ranch area.
) for first-line treatment of type 2 diabetes.

"Maintaining adequate glycemic control is vital to preventing the diabetes-related complications that can increase morbidity and mortality Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
 in patients with type 2 diabetes," said Sherwyn L. Schwartz, MD, lead investigator of the Glumetza phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  and director, Diabetes & Glandular glandular /glan·du·lar/ (glan´du-ler)
1. pertaining to or of the nature of a gland.

2. glanular.


glan·du·lar
adj.
1.
 Disease Clinic of San Antonio. "With Glumetza, patients do not experience a greater incidence of side effects Side effects

Effects of a proposed project on other parts of the firm.
 at the higher doses, which may help them ease titration titration (tītrā`shən), gradual addition of an acidic solution to a basic solution or vice versa (see acids and bases); titrations are used to determine the concentration of acids or bases in solution. , improve adherence, and ultimately achieve their A1C A1C
abbr.
airman first class
 goals."

The primary goal in treating patients with type 2 diabetes is to maintain glycemic levels as close to the nondiabetic range as possible, which the American Diabetes Association (ADA) defines as an HbA1C (A1C) of less than 7%. Because of its efficacy in lowering A1C, metformin is well established as a primary treatment option for type 2 diabetes and is the only pharmacologic therapy recommended for the first-line treatment of the disease in a recent consensus statement from the ADA and the European Association for the Study of Diabetes (EASD EASD

See: European Association of Securities Dealers
).

The ADA and EASD consensus statement recommends that for optimal treatment, metformin be titrated ti·trate  
tr. & intr.v. ti·trat·ed, ti·trat·ing, ti·trates
To determine the concentration of (a solution) by titration or perform the operation of titration.
 to its maximally effective dose. Unfortunately, metformin can sometimes cause gastrointestinal side effects, which may limit the dose that can be tolerated, making it difficult to achieve A1C goals. Glumetza 2000 mg once daily has shown similar efficacy benefits to 1500 mg/day immediate-release metformin as a divided dose without an increase in side effects, an important benefit that may help patients maximize their metformin therapy.

In a randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 phase III clinical trial, the three Glumetza regimens studied (1500 mg/day once daily, 1500 mg/day divided dose, and 2000 mg/day once daily) provided decreases in A1C, fasting plasma glucose and fructosamine levels that were as effective as those observed with 1500 mg/day immediate-release metformin divided dose. Glumetza had a lower incidence of nausea in the first week of treatment than immediate-release metformin at the same dose. Even at the higher dose of 2000 mg/day, Glumetza showed no increase in side effects relative to immediate-release metformin. Additionally, adherence among patients was high; in a low-intervention, 24-week, open-label extension study, 97.2% of patients adhered to Glumetza 2000 mg/day therapy.

"Glumetza represents an important advance in the first-line care of patients with type 2 diabetes," said Brian A. Markison, President and Chief Executive Officer of King Pharmaceuticals. "AcuForm technology makes once-daily dosing of Glumetza possible, and can help provide maximal dosing without an increase in gastrointestinal side effects. We are pleased to provide diabetes patients with a first-line treatment option that can help them achieve their goals." Mr. Markison added, "The addition of Glumetza to King's portfolio of marketed products significantly strengthens our position in cardiovascular/metabolics, one of our three key therapeutic areas of focus."

John W. Fara, Ph.D., Chairman, President and Chief Executive Officer of Depomed said, "We are very pleased with the efficient execution and timely launch of Glumetza following our co-promotion agreement signed with King in June. As we expected, King has effectively mobilized their sales organization around the commercialization of Glumetza, and we expect the once-daily convenience, high tolerability, and other benefits of our technology to allow significant penetration in the $1.4 billion metformin market."

King's primary care sales force and its cardiovascular/metabolic specialty sales force are now detailing Glumetza in the United States. Glumetza is provided as a 500 mg tablet, packaged in bottles of 100, and is now available in pharmacies across the country. More information is available at www.glumetzaxr.com or by calling 1-866-GLUMETZA.

About Glumetza

Glumetza(TM) (metformin hydrochloride extended-release tablets) is indicated alone or in combination with sulfonylurea sulfonylurea /sul·fo·nyl·urea/ (sul?fo-nil-u-re´ah) any of a class of compounds that exert hypoglycemic activity by stimulating the islet tissue to secrete insulin; used to control hyperglycemia in patients with type 2 diabetes mellitus  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 Renal disease
Kidney disease.

Mentioned in: Glycogen Storage Diseases

hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg
 or renal dysfunction (eg, 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 hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen.  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(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 prescribing information 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 1 million new cases each year in the United States alone. Approximately 90% to 95% 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 End-stage renal disease (ESRD)
Total kidney failure; chronic kidney failure is diagnosed as ESRD when kidney function falls to 5-10% of capacity.

Mentioned in: Chronic Kidney Failure

end-stage renal disease 
, and nontraumatic 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.

About King Pharmaceuticals, Inc.

King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on 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. For more information, visit www.kingpharm.com.

About Depomed, Inc.

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) extended-release tablets have been approved by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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 the United States and 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.

Forward-Looking Statements

This release contains forward-looking statements which reflect managements' current views of future events and operations, including, but not limited to, statements pertaining to the potential market penetration of Glumetza(TM) in the metformin market. These forward-looking statements involve certain significant risks and uncertainties, and actual results may differ materially from the forward-looking statements. Some important factors which may cause actual results to differ materially from the forward-looking statements include: dependence on the companies' abilities to carry out their respective business plans; dependence on the commercial acceptance of Glumetza(TM); dependence on the companies' abilities to successfully market Glumetza(TM); dependence on the availability and cost of raw materials; dependence on compliance with U.S. Food and Drug Administration and other government regulations that relate to King's and Depomed's respective businesses; and dependence on changes in general economic and business conditions; changes in current pricing levels; changes in federal and state laws and regulations; changes in competition; unexpected changes in technologies and technological advances; and manufacturing capacity constraints. 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 King's Form 10-K for the year ended December 31, 2005 and Form 10-Q for the second quarter ended June 30, 2006, and Depomed'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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 6, 2006
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