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news.Biovail Corporation and Depomed have been granted regulatory approval by the Therapeutic Products Directorate Canada for Glumetza, a once-daily type 2 diabetes treatment.
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The approval means Glumetza will be the first once-daily, extended-release formulation of metformin on the Canadian market. Biovail Pharmaceuticals Canada (BPC), the company’s sales and marketing division, will commercialize Glumetza in Canada. BPC expects to launch Glumetza in the fourth quarter of 2005.
Clinical data exists to show that reducing the frequency of daily dosing of oral diabetes medication can cause an improvement in patient compliance and metabolic control. Glumetza offers an advantage to both physicians and patients by simplifying the dosage regimen of twice-a-day or three-times-a-day metformin to just once a day.
Glumetza will vie for a share of the C$300-million oral diabetes drug market in Canada, which was characterized by year-over-year growth of 22.8% for the 12-month period ended March 31, 2005. During that period, about 12.1 million prescriptions were written for oral diabetes products to treat type 2 diabetes, and metformin products captured 51.2% of that market in terms of total prescriptions.
In the near future, Biovail and Depomed expect to hear from the FDA with regard to their complete response submitted in April 2005 to the approvable letter for Biovail’s new drug application for 500mg and 1,000mg formulations of Glumetza. Biovail is currently in discussions with several potential partners to market Glumetza in the US.