GlumetzaTreatment for Diabetes Type 2
Biovail, Depomed Announce Glumetza NDA Accepted by FDA
TORONTO & MENLO PARK, Calif., June 24, 2004 - Biovail Corporation (NYSE:BVF) (TSX:BVF) and Depomed, Inc. (Nasdaq:DEPO) announced today that Biovail's New Drug Application (NDA) for Glumetza, a once-daily, extended-release formulation of metformin HCl for the treatment of Type II diabetes, has been accepted for review (effective date June 26, 2004) by the U.S. Food and Drug Administration (FDA).
The application was submitted under the provisions of Section 505(b)(1) of the Food, Drug and Cosmetic Act.
Greg Szpunar, Senior Vice-President, Research and Development, and Chief Scientific Officer at Biovail, said acceptance of the NDA is reflective of the collaborative filing effort between Biovail and Depomed and further validates the depth of Biovail's pipeline.
"This marks the fourth time since the beginning of 2004 that a New Drug Application from Biovail has been accepted for review by the Food and Drug Administration," Szpunar said. "This is indicative of Biovail's strong technological expertise, and its commitment to providing physicians with medicines that offer enhanced therapeutic benefits."
John W. Fara, Ph.D., Chairman, President and Chief Executive Officer of Depomed, added that Depomed is pleased with the progression of the regulatory review for Glumetza.
"This is particularly rewarding as we were able to expand the application to include two dosage forms -- 500 mg and 1,000 mg," Fara said. "Upon approval, we expect this will provide patients and physicians with broader options as they seek to optimize therapeutic benefits and patient convenience."
Diabetes and Metformin Background Information
Glumetza is intended to control Diabetes Mellitus - a condition characterized by high levels of blood glucose resulting from defects in insulin secretion, insulin activity or both. Metformin is indicated for the control of hyperglycemia in metformin-responsive, stable, mild, non-ketosis prone maturity onset type of diabetes (Type II) which cannot be controlled by proper dietary management, exercise and weight reduction and when insulin therapy is not appropriate.
Diabetes affects an estimated 17 million Americans and is increasing by about one million new cases each year in the U.S. alone. About 90 per cent of diabetics suffer from Type II diabetes, which, if not treated, can be associated with serious complications, including heart disease, stroke, high blood pressure, blindness, kidney and nervous-system diseases, amputations and death.
Metformin is a leading treatment for Type II diabetes. While immediate-release formulations must be administered two to three times per day, the newer extended-release formulations submitted today offer the increasingly popular option of once-daily dosing. This will especially aid a number of elderly patients who have difficulty remembering to take their medications at various times of the day.
The large majority of patients currently taking metformin are using the 500-mg dosage, while the new, once-daily 1,000-mg dosage will especially benefit the approximately 35% of diabetes patients who require additional glycemic control.
About Biovail Corporation
Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug-delivery technologies.
Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative Gastric Retention (GR(TM)) system to develop novel oral products and improved formulations of existing oral drugs. GR-based products are designed to provide once daily administration and reduced gastrointestinal side effects, improving patient convenience, compliance and pharmacokinetic profiles. Regulatory applications for once daily Glumetza (Metformin GR) for the treatment of Type II diabetes have been submitted to agencies in the U.S. and Canada, and the company has completed its Phase III clinical trial with once daily Proquin(TM) XR (ciprofloxacin HCl extended-release tablets) for the treatment of urinary tract infections. The company is also conducting a Phase II trial with the diuretic Furosemide GR and plans to initiate a Phase II trial with the seizure and pain drug Gabapentin GR later in 2004.
Posted: June 2004
- Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza - January 2, 2008
- FDA Approves Glumetza for Type 2 Diabetes - June 3, 2005
- Depomed, Biovail Update Status of Glumetza NDA - April 13, 2005
- Biovail, Depomed Receive Approvable Letter from FDA for Extended-Release Glumetza for Type II Diabetes - March 1, 2005
- Biovail and Depomed Submit NDA for Glumetza; Submission Includes 500mg and 1000mg dosages; Biovail/Depomed Expand Royalty Agreement to Include 1000mg dose - April 28, 2004
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