Healthcare Industry News: DITROPAN XL
News Release - September 7, 2006
IMPAX Prevails in Alza's Appeal Related to Generic Version of Ditropan(R) XLHAYWARD, Calif.--(HSMN NewsFeed)--Sept. 7, 2006--IMPAX Laboratories, Inc. (OTC:IPXL ) announced that the U.S. Court of Appeals for the Federal Circuit upheld a lower court ruling in favor of IMPAX in its defense of a lawsuit brought by Alza Corporation, a Johnson & Johnson (NYSE:JNJ ) unit. The suit alleged patent infringement related to IMPAX's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Ditropan® XL (Oxybutynin Chloride) tablets, 5, 10 and 15 mg. Alza Pharmaceuticals markets DITROPAN XL for the treatment of urge urinary incontinence. U.S. sales of DITROPAN XL were approximately $350 million in the 12 months ended May 31, 2006, according to Wolters Kluwer Health.
"We are pleased that yet another court has seen through Alza's attempt to delay the availability to patients of a lower priced alternative to the branded drug," commented Larry Hsu, Ph.D., president of IMPAX. "We received tentative approval for Oxybutynin Chloride 5, 10 and 15 mg Extended Release Tablets in February 2005. Final approval is now dependent on the U.S. Food and Drug Administration's (FDA) resolution of a Citizen's Petition brought by Johnson & Johnson, and on the expiration of any marketing exclusivity. We believe that we were first to file an ANDA on the 15 mg dosage form, and thus could have 180 days of marketing exclusivity following final FDA approval."
The Company's version of generic DITROPAN XL is one of 12 products covered under its strategic alliance entered into in June 2001 with a subsidiary of Teva Pharmaceutical Industries Ltd. Following final FDA approval and the Company's decision to launch, Teva is expected to market the product.
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 two 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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