Biovail Updates Status of NDA for Tramadol ER

    Business Editors/Health/Medical Writers

    TORONTO--(BUSINESS WIRE)--March 30, 2005--Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that it has received comments from the United States Food and Drug Administration (FDA) with regard to its New Drug Application (NDA) for Tramadol ER, an extended-release, once-daily formulation of tramadol hydrochloride.
    The FDA has acknowledged that Biovail's Complete Response to the Tramadol ER Approvable Letter is a Class 2 response, which is therefore subject to a six-month review. The FDA has also advised that, upon preliminary review, it is of the opinion that additional clinical trial data will be required. Biovail's view is that the clinical data contained within the original NDA and the March 2005 Complete Response fully support 505(b)(2) filing requirements, and the Company is considering a number of options. Biovail expects to meet with the FDA to discuss these options promptly. In the meantime, however, Biovail will immediately undertake a clinical program to address the FDA's comments. Biovail anticipates the submission of new clinical data in late 2005 or early 2006. Biovail believes that a new six-month review period would then be initiated.
    Biovail's original application was submitted December 31, 2003 under provisions of Section 505(b)(2) of the Food, Drug and Cosmetic Act. The application included clinical and safety data obtained from four original adequate and well-controlled trials involving more than 3,000 patients who received doses of up to 400mg of Tramadol ER once daily. The application also included 12 definitive and five supportive pharmacokinetic studies which demonstrated that once-daily dosing of Tramadol ER delivers the equivalent amount of drug as Ultram(R) (tramadol hydrochloride tablets) given three times (TID) or four times (QID) per day.
    In October 2004, Biovail's NDA for Tramadol ER received an Approvable Letter from the FDA. In March 2005, Biovail submitted a Complete Response to the FDA, which included a significant amount of statistical analyses, but no new clinical data. The response also addressed other items raised in the Approvable Letter, including discontinuation rates of clinical-trial participants (dropouts), which are common in pain trials, and previously well documented in studies involving tramadol.

    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 further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@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 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 and Canadian Therapeutic Products Directorate 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, the regulatory environment, the outcome of legal proceedings, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Ontario Securities Commission. Biovail undertakes no obligation to update or revise any forward-looking statement.

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CONTACT: Biovail Corporation Kenneth G. Howling, 905-286-3000

KEYWORD: NEW YORK INTERNATIONAL CANADA INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY PRODUCT SOURCE: Biovail Corporation

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