Source: Hong Kong Med J  |  Posted 6 years ago

TORONTO, ON -- June 1, 2005 -- Biovail Corporation BVF (TSX:BVF) and Depomed, Inc. DEPO announced today that the Therapeutic Products Directorate Canada (TPD) has issued a Notice of Compliance for 500mg and 1,000mg Glumetza(TM) a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of Type II diabetes.

Glumetza will be the first once-daily, extended-release formulation of metformin on the Canadian market.

Poor patient compliance to medications and dosing regimens represent a significant challenge to physicians in treating chronic disease - especially diabetes, due to the high number of medications that patients often have to take to control their disease. 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 a significant advantage to both physicians and patients by simplifying the dosage regimen of twice-a-day or three-times-a-day metformin to once a day.

BPC to Commercialize Glumetza(TM) in Canada
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.

"Type II diabetes currently affects more than 2.25 million Canadians," said Dr. Douglas Squires, Chief Executive Officer of Biovail Corporation. "Hyperglycemia is a major cause of many of the complications that happen to people who have diabetes, so keeping your blood sugar as close to normal as possible not only helps you to feel better, but will help to reduce the risk of long-term complications. Providing Canadians with a once-daily metformin option is taking a great step forward in helping to manage this significant compliance challenge."

In the near future, Biovail and Depomed expect to hear from the United States Food and Drug Administration 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. The Complete Response addressed one manufacturing specification.

Biovail is currently in discussions with several potential partners to market Glumetza in the United States.

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 II diabetes, and metformin products captured 51.2% of that market in terms of total prescriptions.

About Glumetza(TM)
Glumetza (metformin hydrochloride) extended-release tablets in 500mg and 1,000mg dosage strengths are indicated for the control of hyperglycemia in adult patients with Type II diabetes (non-insulin-dependant, mature onset), as an adjunct to dietary management, exercise, and weight reduction, or when insulin therapy is not appropriate. Glumetza may be used as monotherapy, or concomitantly with a sulfonylurea.

Glumetza is a once-daily formulation, which must be taken with food to ensure optimum delivery of metformin to the systemic circulation. Clinical data demonstrates that administration of Glumetza in the fed state significantly increases the systemic delivery of metformin, compared with the fasted state. Glumetza can also be of value in the treatment of obese diabetic patients.

Safety Precautions
Do not take Glumetza if you have kidney problems, heart failure that is treated with medicine, or have a condition called metabolic acidosis, including diabetic ketoacidosis, which should be treated with insulin.

Glumetza can cause a rare, but serious condition, called lactic acidosis. Stop taking Glumetza and call your doctor right away if you feel very weak or tired, or have unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, diarrhea or feel cold, especially in your arms and legs, or if you feel dizzy or lightheaded, or have a slow or irregular heartbeat, or a medical condition suddenly changes.

The most common side effects of Glumetza include diarrhea, nausea, and upset stomach.

About Diabetes
Diabetes affects an estimated 2.25 million Canadians, and is increasing by approximately 60,000 new cases each year in Canada alone. Approximately 90% of diabetics suffer from Type II diabetes, the most common metabolic disease in the world and the seventh-deadliest disease in the Canada. Diabetes is the leading cause of blindness, end-stage renal disease and non-traumatic loss of limb and can also lead to heart disease, stroke, high blood pressure, kidney disease and other serious conditions. In Canada, the public health cost of diabetes is estimated to be more than C$9 billion per year.

SOURCE: Biovail