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NDA Submitted for Glumetza, Once Daily, Extended Release Formulations of Metformin
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(TM) 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 500mg, once daily, extended release formulation of metformin HCl. Per this agreement, Biovail will pay a $25 million milestone payment and product royalties to Depomed upon approval of the 500mg dosage form. Subsequent to this agreement, Biovail began an internal program to develop a 1000mg extended release tablet to broaden its product offerings for diabetes.
Through the amended agreement, Depomed gains royalty rights to Biovail's 1000mg tablet for metformin HCl for sales in the U.S. and Canadian territories in exchange for allowing Biovail to use Depomed's clinical data on 500 mg metformin HCl 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(TM) 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(TM) 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(TM) for commercialization in the U.S. as its sales force is fully deployed.
Source: Biovail Corporation and Depomed, Inc.