Healthcare Industry News:  Wellbutrin 

Biopharmaceuticals Drug Delivery FDA

 News Release - July 23, 2007

Biovail Responds to Investor Enquiries

TORONTO--(HSMN NewsFeed)--Biovail Corporation (NYSE:BVF ; TSX:BVF ) responded today to various media and shareholder enquiries relating to the recent BVF-033 Non-Approval Letter from the U.S. Food & Drug Administration (FDA), which was disclosed by Biovail on July 20, 2007. Biovail remains committed to securing the approval of BVF-033, which would allow the Company to move forward with the development and commercial launch of BVF-045 - a combination product incorporating BVF-033 with an undisclosed anti-depressant agent.

The Non-Approval Letter focused primarily on the design of the pharmacokinetic (PK) studies required for approval of the product, and not on safety or efficacy concerns. Biovail believes the studies it conducted were appropriate. Biovail had already responded to other items raised in regard to the Chemistry, Manufacturing and Controls (CMC) section of the NDA in previous submissions to the FDA. Biovail expects to meet with the FDA as soon as possible to discuss the most expeditious path forward for BVF-033.

"While the delay in the expected approval timeline for BVF-033 was disappointing, the product wasn't contemplated in Biovail's 2007 financial guidance," said Dr. Douglas Squires, Biovail's Chief Executive Officer. "Further, given the Company's promising product-development pipeline, strong financial position including over $450 million in cash, no long-term debt and strong cash-flow generation from its business model, Biovail's Board of Directors has no intention of changing its current dividend policy". Biovail's current dividend policy contemplates the payment of $1.50 in annual dividends per common share, paid in quarterly increments of $0.375 per share, at the discretion of the Company's Board of Directors.

"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, and may be forward-looking information within the meaning of the "safe harbor" provisions of applicable Canadian provincial securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates, outlook and guidance, including, without limitation, expectations regarding its pipeline and product cycle, expectations regarding regulatory filings to the FDA and the Company's guidance for 2007 in respect of its total revenues, EPS and cash flows from operations, and can generally be identified by the use of words such as "guidance", "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.

Although Biovail believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: a decrease in sales of Wellbutrin XL®, the difficulty of predicting U.S. Food and Drug Administration, Canadian Therapeutic Products Directorate and European regulatory 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, tax rate assumptions, 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, as well as the Company's ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release, as well as under the heading "Risk Factors" contained in Item 3(D) of Biovail's most recent Annual Report on Form 20-F/A.

The Company cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on Biovail's forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Biovail undertakes no obligation to update or revise any forward-looking statement.

About Biovail Corporation

Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the Company's Web site at

Source: Biovail

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