Healthcare Industry News: Biovail
News Release - March 5, 2007
IMPAX Settles Patent Litigation Related to Generic Wellbutrin(R) XLHAYWARD, Calif.--(HSMN NewsFeed)--IMPAX Laboratories, Inc. (OTC:IPXL ; "IMPAX" or "the Company") announced today that it has settled its patent litigation suit with Biovail Laboratories International SRL related to IMPAX's version of Bupropion Hydrochloride Extended-Release Tablets, generic of WellbutrinŽ XL, 150 mg and 300 mg. The settlement was made pursuant to an agreement among the Company, Biovail, a subsidiary of Teva Pharmaceutical Industries Ltd., and Anchen Pharmaceuticals.
The litigation will be dismissed with Biovail granting to Teva an exclusive license to market the IMPAX 300 mg strength product for the period from December 13, 2006 until June 13, 2007, and non-exclusive thereafter. Under their Strategic Alliance agreement, Teva launched IMPAX's 300 mg product in December 2006 pursuant to an exclusivity transfer agreement with Anchen, who was awarded first-to-file exclusivity for both the 300mg and 150mg dosage strengths.
With respect to the 150 mg product, IMPAX has amended its Strategic Alliance agreement with Teva, such that Teva will market Anchen's product during Anchen's 180-day period of exclusivity and pay a royalty to IMPAX rather than any profit share. Following this 180-day period, IMPAX will market the 150 mg dosage strength either through Teva, or on its own should Teva elect to continue marketing Anchen's product. The settlement agreement also includes license grants for the 150mg product, which will commence in 2008 or earlier under certain specified circumstances.
"This lawsuit has consumed financial resources and management time, and we are very pleased to put this to rest," said Larry Hsu, Ph.D., president and chief executive officer of IMPAX.
Wellbutrin XL is marketed by GlaxoSmithKline for the treatment of depression. The 150 mg and 300 mg versions together had U.S. sales in excess of $1.8 billion for the 12 months ended December 31, 2006, according to Wolters Kluwer Health.
About IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and markets its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause IMPAX's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, possible adverse effects resulting from the delisting of IMPAX's stock, IMPAX's delay in filing its 2004 Form 10-K, its Form 10-Q for each of the first three quarters of 2005, its Form 10-K for 2005, and its Form 10-Q for each of the first three quarters of 2006, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and IMPAX undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
Source: IMPAX Laboratories
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