Glumetza

metformin extended release

Biovail and Depomed Submit NDA for Glumetza; Submission Includes 500mg and 1000mg dosages; Biovail/Depomed Expand Royalty Agreement to Include 1000mg dose

TORONTO, Canada & MENLO PARK, Calif., April 28, 2004 -- Biovail Corporation (NYSE:BVF)(TSX:BVF) and Depomed, Inc. (Nasdaq:DEPO) announced today that they had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for 500mg and 1000mg tablets of Glumetza, once daily, extended release formulations of metformin. The submission occurred simultaneously as Biovail and Depomed amended their license agreement to cover both dosage strengths. The 500mg dosage strength was developed utilizing Depomed's Gastric Retention (GR) drug delivery technology and the 1000mg dosage strength was developed by Biovail's Smartcoat delivery technology.

Depomed conducted two double-blind Phase III clinical trials for its 500 mg dose in over 1000 patients with Type II diabetes. Patients receiving the product demonstrated excellent glycemic control over 24 and 48 weeks, including substantial reductions in HbA1c that were maintained over that period. In addition, within one week, sizable reductions in fasting plasma glucose were achieved and maintained throughout the studies. Glumetza was well tolerated in terms of gastrointestinal adverse events and had an excellent safety profile. Biovail conducted multiple studies to demonstrate equivalency for its 1000mg dosage strength to Depomed's 500mg dosage strength.

Biovail and Depomed Expand Agreement
Biovail and Depomed also announced today that the companies have amended their license agreement to cover both dosage strengths. Under the original agreement of May 2002, Biovail acquired U.S. and Canadian marketing rights to Depomed's 500 mg, once daily, extended release formulation of metformin HC1. Per this agreement, Biovail will pay a $25 million milestone payment and product royalties to Depomed upon approval of the 500 mg dosage form. Subsequent to this agreement, Biovail began an internal program to develop a 1000 mg extended release tablet to broaden its product offerings for diabetes.

Through the amended agreement, Depomed gains royalty rights to Biovail's 1000 mg tablet for metformin HC1 for sales in the U.S. and Canadian territories in exchange for allowing Biovail to use Depomed's clinical data on 500 mg metformin HC1 tablets to support and accelerate regulatory submissions for Biovail's 1000 mg tablet and establish equivalence between the two dosage forms.

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 approximately one million new cases each year in the U.S. alone. Approximately 90% of diabetics suffer from type II diabetes, which can be associated with serious complications, including heart disease, stroke, high blood pressure, blindness, kidney and nervous system diseases, amputations and death if not treated.

Metformin is a leading treatment for Type II diabetes and 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 500mg dosage, while the new once-daily 1000mg dosage will especially benefit the approximately 35% of diabetes patients requiring additional glycemic control.

Biovail also recently submitted a New Drug Submission in Canada for Glumetza that will be launched by Biovail Pharmaceuticals Canada to help treat the two million Canadians suffering from Type II diabetes. Biovail intends to out-license Glumetza for commercialization in the U.S. as its sales force is fully deployed.

About Depomed
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. An NDA with once daily Metformin GR for the treatment of Type II diabetes has been submitted to the FDA and the company has completed its Phase III clinical trial with once daily Ciprofloxacin GR 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.
Additional information about Depomed may be found at its web site, www.depomedinc.com

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.
For further information, please visit www.biovail.com

Related Articles:

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, Depomed Announce Glumetza NDA Accepted by FDA - June 24, 2004

Latest New Drug Applications...

Daily MedNews
Pharma Industry News
New Drug Applications
New Drug Approvals
Clinical Trial Results
Generic Drug Approvals