FDA Approves Biovail's Cardizem LA for Hypertension.

Business Editors, Health & Medical Writers

TORONTO--(BUSINESS WIRE)--Feb. 7, 2003

Biovail Corporation (NYSE:BVF)(TSX:BVF)

-- Cardizem(R) LA "graded release" provides 24-hour blood pressure control

-- Convenience and flexibility of once-daily dosing

-- Clinical trials indicate safety and tolerability even at higher doses

-- Conference call scheduled for 11:30 a.m. E.S.T.

Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that the U.S. Food and Drug Administration (FDA) has approved Cardizem(R) LA, a new graded extended-release formulation of diltiazem HCl for the treatment of high blood pressure or hypertension. Cardizem(R) LA -- long acting -- provides 24-hour blood pressure control with a single daily dose and a flexible dosing range from 120mg to 540mg. Cardizem(R) LA is the only product labeled to allow administration in either the morning or the evening. With evening administration and the unique graded release technology, clinical trials have shown increased reduction in blood pressure in the early morning hours, which is when patients may be at greatest risk of significant cardiac events.

"Cardizem(R) LA is the first New Drug Application (NDA) product that Biovail will launch directly to physicians using our own fully-integrated sales force in the United States," stated Eugene Melnyk, Chairman and CEO of Biovail. "The introduction of Cardizem(R) LA offers physicians a once daily formulation of the compound diltiazem, a drug that is well-regarded for its safety profile and one with a brand name that physicians have come to know and trust."

Hypertension

Clinical studies indicate that morning or evening dosing of Cardizem(R) LA provides effective 24-hour blood pressure control.

"Uncontrolled hypertension plays a significant role in the deaths of hundreds of thousands of heart-disease patients in the U.S. each year,(1)" said Joel Neutel, MD, assistant clinical professor, University of California at Irvine. "With the approval of Cardizem(R) LA, we now have a proven therapy that provides effective and safe 24-hour blood pressure control with potential added benefits for patients with specific hypertensive risks."

Approximately 50 million American adults -- or one in four -- have high blood pressure, and 25 percent of these are not adequately treated. Uncontrolled hypertension kills 430,000 Americans each year and contributes to the deaths of 210,000 others.

Clinical Studies

In two randomized, placebo-controlled clinical trials, Cardizem(R) LA demonstrated dose-related mean reductions in trough diastolic blood pressure (DBP) following evening administration of 120mg, 240mg, 360mg and 540mg doses when compared to placebo. Reductions ranged from -2.0 millimeters of mercury (mm/Hg) with the 120mg dose to -8.1mm/Hg with the 540mg dose. A similar range of morning doses showed a linear decrease in DBP from -1.9mm Hg with a 120mg dose to -8.6mm/Hg with 540mg. All doses above 120mg maintained their anti-hypertensive effect for a complete 24-hour period. Side effects at dosages up to 540mg were similar to placebo.

"The data demonstrate that Cardizem(R) LA delivers 24-hour blood pressure control whether dosed in the morning or the evening," said Stephen Glasser, MD, professor of epidemiology at the University of Minnesota, School of Public Health. "We continue to explore the clinical significance of the blood pressure effect of evening Cardizem(R) LA administration and have seen favorable clinical trial results in the treatment of angina."

The most commonly reported side effects with Cardizem(R) LA were headache, edema and upper respiratory tract infection. Side effect incidence was similar to placebo.

Cardizem(R) LA 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 AV block, except in the presence of a functioning ventricular pacemaker. Patients should also avoid Cardizem(R) LA if they have hypotension (less than 90mm/Hg systolic blood pressure), hypersensitivity to diltiazem or acute myocardial infarction and pulmonary congestion confirmed by x-ray.

Cardizem(R) LA will be launched in doses of 120mg, 180mg, 240mg, 300mg, 360mg and 420mg. Dosing up to 540mg has been approved by the FDA and Biovail currently has a single dose 540mg product under development.

Other Clinical Studies

In October of 2002, Biovail released the positive results from a Phase III clinical trial focused on the use of Cardizem(R) LA in chronic stable angina pectoris. This study illustrated that significantly greater efficacy is demonstrated in the morning time period when dosed in the evening and that evening dosing demonstrates efficacy 24 hours after dosing in patients with chronic stable angina. Biovail intends to file an NDA for the treatment of angina with the FDA based on the results of this study.

Three Cardizem(R) LA Phase IV clinical studies have been initiated comparing Cardizem(R) LA to ramipril and to amlodipine. One of these studies involves African American patients with hypertension. A second study involves diabetic patients with proteinuria. Both of these trials are progressing on schedule. A third study, which was completed in October of 2002, evaluated the safety and efficacy of Cardizem(R) LA dosed at night compared to the ACE-inhibitor ramipril also dosed at night in patients with stage-one and stage-two central hypertension. Results of this study showed that, versus ramipril, Cardizem(R) LA not only provided better blood pressure control during the critical morning hours but better blood pressure control over a full 24 hours.

Biovail expects to launch Cardizem(R) LA commercially on April 2, 2003.

Conference Call Details

The management of Biovail will host a conference call today at 11:30 AM EST to discuss the clinical benefits and commercial programs related to Cardizem(R) LA. During the call, Biovail management will also discuss its 2003 revenue and earnings per share guidance. Following the discussion, Biovail executives will address inquiries from investment analysts.

A live webcast of this call will be available through the Investor Relations section of the Biovail web site, www.biovail.com. To access this live call, please dial 1-416-640-4127 (Toronto area and International) and 1-800-814-4853 (Toll Free). A replay of the conference call will be available until 7:00 p.m. EST on Friday February 14, 2003 by dialing 1-416-640-1917 (Toronto area and International) or 1-877-289-8525 (Toll Free), using access code 237001 for both.

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. More information on Biovail Corporation can be found on http://www.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 essentially forward looking and are subject 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, 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.

(1) Philadelphia Inquirer. Nov. 13, 2002: A01.