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FDA Approves Cardizem LA for Angina

FDA Approves Biovail's Cardizem LA for the Treatment of Angina

TORONTO April 5, 2004 -- Biovail Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved Cardizem LA, for the treatment of chronic stable Angina. Cardizem LA can be given orally once daily, either in the evening or in the morning.

Cardizem LA is already approved for the treatment of high blood pressure or hypertension and is a long acting extended-release formulation of diltiazem HCl. Cardizem LA provides 24-hour blood pressure control with a single daily dose. Cardizem LA may blunt a rise in blood pressure in the early morning which is when risk of an ischemia-associated cardiovascular event is highest.

The dual indication of Cardizem LA in hypertension and chronic stable angina combined with its unique pharmacokinetic profile to deliver the drug makes Cardizem LA an excellent choice for the physician in the management of two very important cardiovascular risk factors.

Cardizem LA is the first product that Biovail developed and launched directly to physicians using its own fully-integrated sales force in the United States. Cardizem LA's clinical benefits are resonating well with physicians and Biovail's recent sales force initiatives have resulted in the attainment of new once-daily diltiazem HCl market share highs for Cardizem LA for both Total Prescriptions (10.4%) and New Prescriptions (7.3%). Biovail has recently completed a Territory Realignment initiative resulting in better geographic coverage and work-load balance for its U.S. primary care sales force.

"The timing for receiving the additional indication of angina for Cardizem LA also aligns well with the launch of Biovail's new cardiovascular specialty sales force which will be dedicated to promoting Cardizem LA, Teveten/Teveten HCT and future products to cardiovascular specialists," commented Eugene Melnyk, Chairman and Chief Executive Officer. "Biovail has completed the identification and alignment process for all 63 territories for the cardiovascular specialty sales force and is in the final stages of completing the hiring process for the remaining unfilled positions."

About Angina

Angina pectoris (also referred to as angina) is a recurring pain or discomfort in the chest when some part of the heart does not receive enough blood. It is a common symptom of coronary heart disease, which occurs when vessels that carry blood to the heart become narrowed and blocked due to atherosclerosis. It is a prevalent disease; currently affecting 6.4 million people in the U.S. with 400,000 new cases diagnosed each year. Chronic angina patients currently need to receive on average two drugs to treat the disease, and only 17% of those patients think their pain is satisfactorily controlled.

Angina is often controlled by drugs. The choice of drug is usually dependent on the acuity and severity of the symptoms as well as the presence of other existing conditions. Cardizem LA, a calcium channel blocker (CCB) is effective in reducing the frequency and severity of angina attacks either used alone or in combination with other medications. In many patients a combination of agents is more effective than therapy with only one medication.

Cardizem LA Clinical Study in Angina

The effects of Cardizem LA on angina were evaluated in a randomized, double-blind, parallel-group, dose-response trial of 311 patients with chronic stable angina. Evening doses of 180, 360 and 420 mg were compared to placebo and to 360 mg administered in the morning. All doses of Cardizem LA administered at night increased exercise tolerance when compared with placebo after 21 hours. The mean effect, placebo-subtracted, was 20 to 28 seconds for all three doses, and no dose-response was demonstrated. Cardizem LA, 360 mg, given in the morning, also improved exercise tolerance when measured 25 hours later.

In the angina study, the adverse event profile of Cardizem LA was consistent with what has been previously described for Cardizem LA and other formulations of diltiazem HCl. Among the Cardizem LA dose groups, adverse events occurred at a rate equivalent to or less than placebo. Adverse events were generally mild to moderate in nature. The most frequent adverse effects experienced by Cardizem LA-treated patients were lower-limb edema, dizziness, fatigue, bradycardia, first-degree atrioventricular block, and cough

Chronic oral administration of diltiazem HCl to patients in doses up to 540 mg/day has resulted in small increases in PR interval, and on occasion produces abnormal prolongation. Patients taking other drugs that are substrates of CYP450, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain therapeutic blood levels.

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.

"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 company's filings with the Securities and Exchange Commission.

Posted: April 2004

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