Healthcare Industry News: Impax Laboratories
News Release - March 5, 2007
Biovail Announces Comprehensive Settlement Related to Wellbutrin XL(R)TORONTO--(HSMN NewsFeed)--Biovail Corporation (NYSE, TSX: BVF News) today announced, following a review by the Federal Trade Commission (FTC) that was requested by the parties, a comprehensive settlement with Anchen Pharmaceuticals LLP, Impax Laboratories, Inc., Watson Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd., related to Wellbutrin XL®. Biovail had initiated patent-infringement litigation against certain parties that had filed abbreviated new drug applications seeking approval to launch generic formulations of Wellbutrin XL®, prior to the expiry of its patents.
Certain aspects of the settlements are confidential. However, the essential terms include:
i) Biovail's legal actions against Impax and Watson will be dismissed, with mutual releases in each case.
ii) With defined exceptions, none of Teva/Anchen/Impax/Watson may market a generic version of the 150mg strength of Wellbutrin XL® until 2008.
iii) Biovail has granted an exclusive license under its patent to Teva/Anchen/Impax to market a generic version of the 300mg strength of Wellbutrin XL®, from December 13, 2006 until June 13, 2007. Thereafter, the license becomes non-exclusive.
iv) Biovail has granted Teva/Anchen/Impax an exclusive license to market a generic version of the 150mg strength Wellbutrin XL® for a period of 180 days following market entry. Thereafter, the license becomes non-exclusive.
v) With defined exceptions, Biovail may be required to supply Teva with a limited amount of 150mg and 300mg Wellbutrin XL® product, at a pre-determined supply price, for specifically delineated periods of time.
vi) Pursuant to the terms of an agreement between GlaxoSmithKline plc (GSK) and Andrx Corporation, the patent-infringement suit by Andrx in respect of Andrx's patent purportedly covering the 150mg Wellbutrin XL® product was dismissed, with a resulting license to GSK to continue to market the 150mg Wellbutrin XL® product. Biovail has agreed to pay one-third of the license costs. As a result of this settlement, all outstanding impediments affecting the 150mg Wellbutrin XL® product were extinguished.
Biovail's legal action against Abrika Pharmaceuticals LLLP is not impacted by the settlement and continues in its normal course.
Separately and independently of these settlements relating to Wellbutrin XL®, Biovail and Watson have terminated their existing agreement, which provided Biovail certain access to reference Watson's diltiazem toxicity data. As a result, Biovail's obligation to pay Watson an annual royalty with respect thereto has been extinguished.
As the settlement will have a positive effect on Biovail's 2007 revenues for the Wellbutrin XL® product line, Biovail is assessing this development and all other components of its financial guidance for 2007, and will provide an update concerning 2007 guidance, if necessary, on its conference call to discuss fourth quarter and full-year 2006 earnings, which is currently scheduled for March 15, 2007.
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.
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