Biovail Corporation
NYSE : BVF
TSX : BVF

Biovail Corporation
Depomed, Inc.
NASDAQ : DEPO

Depomed, Inc.

June 01, 2005 08:32 ET

Biovail, Depomed Announce Regulatory Approval of Glumetza to Treat Type II Diabetes in Canada

TORONTO and MENLO PARK, Calif.--(CCNMatthews - Jun 1, 2005) -

Biovail Corporation (NYSE:BVF) (TSX:BVF) and Depomed, Inc. (Nasdaq:DEPO) announced today that the Therapeutic Products Directorate Canada (TPD) has issued a Notice of Compliance for 500mg and 1,000mg Glumetza™, 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™ 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™

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.

About Depomed Inc.

Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative Gastric Retention (GR™) 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. Additional information about Depomed may be found at its Web site, at www.depomedinc.com.

About Biovail Corporation

Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the Company's Web site at www.biovail.com.

For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com.

"Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995

To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration and Canadian Therapeutic Products Directorate approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, tax rate assumptions, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Ontario Securities Commission. Biovail undertakes no obligation to update or revise any forward-looking statement.

Contact Information

  • Biovail Corporation
    Kenneth G. Howling, 905-286-3000
    Vice-President, Finance and Corporate Affairs
    or
    Depomed, Inc.
    Sylvia Wheeler, 650-462-5900
    Senior Director, Corporate Communications