Biovail, Depomed Announce Glumetza NDA Accepted by FDA.

TORONTO & MENLO PARK, Calif. -- Biovail Corporation (NYSE:BVF) (TSX:BVF) and Depomed, Inc. (Nasdaq:DEPO) announced today that Biovail's New Drug Application (NDA) for Glumetza(TM), a once-daily, extended-release formulation of metformin HCl for the treatment of Type II diabetes, has been accepted for review (effective date June 26, 2004) by the U.S. Food and Drug Administration (FDA).

The application was submitted under the provisions of Section 505(b)(1) of the Food, Drug and Cosmetic Act.

Greg Szpunar, Senior Vice-President, Research and Development, and Chief Scientific Officer at Biovail, said acceptance of the NDA is reflective of the collaborative filing effort between Biovail and Depomed and further validates the depth of Biovail's pipeline.

"This marks the fourth time since the beginning of 2004 that a New Drug Application from Biovail has been accepted for review by the Food and Drug Administration," Szpunar said. "This is indicative of Biovail's strong technological expertise, and its commitment to providing physicians with medicines that offer enhanced therapeutic benefits."

John W. Fara, Ph.D., Chairman, President and Chief Executive Officer of Depomed, added that Depomed is pleased with the progression of the regulatory review for Glumetza(TM).

"This is particularly rewarding as we were able to expand the application to include two dosage forms -- 500 mg and 1,000 mg," Fara said. "Upon approval, we expect this will provide patients and physicians with broader options as they seek to optimize therapeutic benefits and patient convenience."

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

Metformin is a leading treatment for Type II diabetes. 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 500-mg dosage, while the new, once-daily 1,000-mg dosage will especially benefit the approximately 35% of diabetes patients who require additional glycemic control.

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.

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. Regulatory applications for once daily Glumetza(TM) (Metformin GR) for the treatment of Type II diabetes have been submitted to agencies in the U.S. and Canada, and the company has completed its Phase III clinical trial with once daily Proquin(TM) XR (ciprofloxacin HCl extended-release tablets) 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.

"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 FDA 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, availability of raw materials and finished products, third parties, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the companies' filings with the Securities and Exchange Commission.