Healthcare Industry News:  GSK 

Biopharmaceuticals Regulatory

 News Release - January 16, 2007

Wellbutrin XR(R) Receives First European Approval

Marketing License Granted in The Netherlands for Adult Patients with Depression

TORONTO--(HSMN NewsFeed)--Biovail Corporation (NYSE:BVF ; TSX:BVF ) marketing partner GlaxoSmithKline (GSK) today announced that Wellbutrin XR(1) (bupropion hydrochloride modified-release tablets), has been granted a marketing license in The Netherlands for the treatment of adult patients with major depressive episodes. The medicine is also considered approvable by the regulatory agencies of 21 other countries(2) under the Decentralized Procedure.

It is expected that regulatory agencies in various European countries will grant national licenses for Wellbutrin XR throughout the first quarter of 2007, and that the medicine could begin to be available to patients from April 2007.

Wellbutrin XR is available as a 150mg or 300mg tablet, with a dose of up to 300mg once daily, starting with 150mg once daily.

Pursuant to the agreement signed in 2001 between Biovail and GSK, Biovail will manufacture and supply the product to GSK at a fixed, contractually determined price.


(1)According to GSK, Wellbutrin XR will be the most common trade name in European countries. Other trade names include: Elontril (several countries), Voxra (Sweden) and Wellbutrin Retard (Norway).

(2)Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, and Sweden.

"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

Source: Biovail

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