Biovail Announces Regulatory Approval of Tiazac XC to Treat Hypertension in Canada.

TORONTO -- Extended-Release Tablet Formulation Taken at Bedtime Designed to Provide 24-Hour and Improved Early-Morning Blood-Pressure Control

Biovail Corporation (TSX:BVF) (NYSE:BVF) today announced that the Therapeutic Products Directorate (TPD) has approved TIAZAC(R) XC for the treatment of hypertension.

TIAZAC(R) XC (diltiazem HCl) represents a further advance in the treatment of hypertension, combining Biovail's advanced drug-delivery technology with the proven efficacy of diltiazem, a calcium channel blocker (CCB) that has been trusted by Canadian physicians for more than 20 years.

Biovail Pharmaceuticals Canada, the company's Canadian sales and marketing division, is currently in discussions with health-care professionals regarding the additional benefits of TIAZAC(R) XC. Biovail plans to launch TIAZAC(R) XC in the first quarter of 2005.

Building on the success of Biovail's TIAZAC(R), Canada's leading once-daily diltiazem formulation, TIAZAC(R) XC features a new extended-release delivery system designed for night-time administration, resulting in improved 24-hour blood-pressure (BP) control with additional BP control during the early morning hours.

Under steady-state conditions, night-time administration of Tiazac XC resulted in significantly greater plasma diltiazem levels between 6 a.m. and 12 noon, relative to morning administration when the incidence of cardiovascular events is highest.

"For many years, TIAZAC(R) has provided physicians and specialists with a proven, once-daily solution to reduce blood pressure," said Suzanne Villeneuve, Vice-President and General Manager of Biovail Pharmaceuticals Canada, the Canadian sales and marketing arm of Biovail Corporation. "The introduction of TIAZAC(R) XC represents a significant advance in diltiazem-based therapy."

The improved release technology in TIAZAC(R) XC allows for bedtime administration, thereby targeting the high-risk morning surge in blood pressure that most patients experience and potentially reducing side effects.

Early-morning elevations in blood pressure are associated with increased cardiovascular risk. Research has shown these rises in blood pressure may be an important factor in the increased incidence of potentially life-threatening cardiovascular events - especially from 6 a.m. to noon. Data show a 40% higher risk of heart attack, a 29% higher risk of cardiac death and a 49% higher risk of stroke during these critical morning hours.

As with all diltiazem formulations, TIAZAC(R) XC should not be used by patients who have abnormal heart rhythms due to sick-sinus syndrome or very slow heartbeats as a result of second-or third-degree heart block, except in the presence of a functioning ventricular pacemaker. Patients should also avoid TIAZAC(R) XC if they have hypotension (less than 90 mm Hg systolic blood pressure), hypersensitivity to diltiazem, or acute myocardial infarction and pulmonary congestion confirmed by x-ray.

About TIAZAC(R) XC

TIAZAC(R) XC (diltiazem HCl) is indicated for the treatment of high blood pressure (hypertension). TIAZAC(R) XC is a brand name for once-daily, extended-release tablet formulations for bedtime administration in dosages of 180 mg-360 mg per day. TIAZAC(R) XC works by slowing the heart rate, and by relaxing and widening blood vessels (arteries), which reduces blood pressure. Widening of the coronary arteries also increases the amount of blood reaching the heart, which can reduce the symptoms of angina. TIAZAC(R) XC belongs to a class of anti-hypertensive drugs known as non-dihydropyridine calcium channel blockers (CCBs).

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. For more information about Biovail, visit the company's Web site at www.biovail.com.

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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 ("FDA") and Canadian Therapeutic Products Directorate ("TPD") 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 company's filings with the Securities and Exchange Commission ("SEC") and the Ontario Securities Commission ("OSC").