Biovail Receives Canadian Approval for Ralivia™

TORONTO--(BUSINESS WIRE)--Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that the Therapeutic Products Directorate (TPD) Canada has issued a Notice of Compliance (NOC) for 100mg, 200mg and 300mg tablet strengths of Ralivia™, the Company’s once-daily, extended-release formulation of tramadol hydrochloride indicated for the management of pain of moderate severity in patients who require continuous treatment for several days or more.

Biovail Pharmaceuticals Canada (BPC), Biovail’s Canadian sales and marketing division, will introduce the features and benefits of Ralivia™ to health-care professionals throughout Canada. BPC anticipates launching Ralivia™ shortly.

“The receipt of a Notice of Compliance for once-daily Ralivia™ is the first important pillar in the establishment of Biovail’s family of pain-management medicines in Canada,” said Scott Smith, Vice-President and General Manager of BPC. “Ralivia™ is formulated using Biovail’s proprietary Smartcoat™ technology to provide 24-hour delivery for more constant plasma concentration and clinical effects with less peak-to-trough fluctuation. Therefore, Biovail believes that the availability of Ralivia™ will offer health-care practitioners another compelling treatment option for their patients who suffer from pain of moderate severity.”

The Ralivia™ formulation approved by the TPD is identical to Biovail's once-daily formulation of tramadol that received approval from the United States Food and Drug Administration (FDA) in September 2005. The product, Ultram® ER, was launched in the U.S. and Puerto Rico by Ortho-McNeil, Inc., a Johnson & Johnson company, and is the only once-daily, extended-release formulation of tramadol available in the United States.

Comprehensive Clinical Package

Ralivia™ was approved based on 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 once daily. Biovail’s NDS submission also included 12 definitive and five supportive pharmacokinetic studies.

Significant Market Opportunity

A significant market opportunity exists for once-daily formulations of tramadol hydrochloride in the Canadian pain market. Statistics from IMS Health show that sales for the 12 months ended June 30, 2007 for pain products in Canada were $872.2 million on 27.3 million total prescriptions.

Safety Precautions

As with all medications, patients who are prescribed Ralivia™ may experience side effects, which are most likely to present shortly after the commencement of treatment. The most common side effects identified by patients taking tramadol include: dizziness, nausea, constipation and headache.

About Tramadol

Tramadol is a centrally acting synthetic opioid analgesic, effective in the treatment of pain. Tramadol has two complementary mechanisms of action: binding to opioid receptors and inhibition of the reuptake of norepinephrine and serotonin.

Caution Regarding Forward-Looking Information and "Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995

To the extent any statements made in this press 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 within the meaning of the “safe harbor” provisions of applicable Canadian securities legislation. These forward-looking statements relate to, among other things, our objectives, goals, strategies, intentions, plans estimates and outlook, and can generally be identified by the use of 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.

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: acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, regulatory matters including compliance with pharmaceutical regulations, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, consolidated tax-rate assumptions, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the U.S. Securities and Exchange Commission (“SEC”), the Ontario Securities Commission (“OSC”), and other securities regulatory authorities in Canada. Additional information about these factors and about the material factors or assumptions underlying any such forward-looking statements may be found in our current Annual Report on Form 20-F, and in particular under the heading “Risk Factors” under Item 3, Sub-Part D. Biovail cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on our 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. We undertake 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 www.biovail.com.

For further information, please contact Nelson F. Isabel at 905-286-3000 or send inquiries to ir@biovail.com.