NDA for Ralivia FlashDose

Business Editors/Health/Medical Writers

TORONTO--(BUSINESS WIRE)--March 11, 2004

Biovail Corporation (NYSE:BVF) (TSX:BVF) announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for Ralivia(TM) FlashDose(R), an orally disintegrating tablet version of the analgesic medication tramadol hydrochloride, intended for the treatment of moderate to moderately severe pain. Biovail recently announced the filing of Ralivia(TM) ER a once daily, extended release form of tramadol.

Tramadol is currently sold in the United States under the brand name Ultram(R) with approximately 11 million prescriptions dispensed during for the twelve months ended December 31, 2003 including generics. Total sales for tramadol immediate release products were $150 million for the same period. The combined market for narcotic and non-narcotic analgesics generated sales of $13.9 billion in the United States for this same time period.

Eugene Melnyk, Chairman of the Board and Chief Executive Officer commented, "The filing of Ralivia FlashDose is very significant, complementing our filing of Ralivia ER and marking our development of a franchise of pain medications. We continue development of a FlashDose(R) form of a tramadol/acetaminophen combination product. The submission of this important product is a further establishment of Biovail's FlashDose technology and its application to making medicines more acceptable and convenient for patients." Biovail is evaluating options for commercialization of the pain franchise and is currently in discussions with multiple potential partners regarding out-licensing Ralivia ER alone or in conjunction with Biovail's orally disintegrating pain products.

The application for Ralivia FlashDose was submitted under the provisions of Section 505(b)(2) of the Food, Drug and Cosmetic Act. The goal of Biovail's biopharmaceutics program was to develop a formulation that would deliver an equivalent amount of drug to the systemic circulation as the listed drug Ultram(R), but in a dosage form that offers a choice of administration with or without water, thereby providing a benefit to patients of comparable efficacy and safety with a greatly simplified dosing regimen and potentially higher compliance.