IMPAX Announces Alza's Lawsuit Related to Generic Version Of Concerta

September 02, 2005

HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 2, 2005--IMPAX Laboratories, Inc. (OTC:IPXL) today announced that Alza Corporation and McNeil-PPC, Inc. have filed a complaint against the Company in the United States District Court for the District of Delaware, alleging patent infringement related to IMPAX's filing for a generic version of Concerta(r). The plaintiffs have not served IMPAX with the complaint. IMPAX has submitted its filing with the U.S. Food and Drug Administration (FDA) under Paragraph IV of the Hatch-Waxman Amendments, stating that it believes its generic versions of Concerta(r) tablets do not infringe the listed patents or that the listed patents are invalid or unenforceable.

Concerta is marketed by McNeil Consumer & Specialty Pharmaceuticals, a division of Johnson & Johnson as a once-daily treatment for attention deficit disorder/attention deficit hyperactivity disorder. According to NDCHealth, U.S. sales of Concerta tablets were approximately $770 million in the 12 months ended July, 2005.

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 intends to market 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:

"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. In particular, the forward-looking statements include statements about IMPAX's common stock trading through the "pink sheets" and making required filings with the Securities and Exchange Commission and otherwise satisfying Nasdaq listing standards in order to regain the listing of its common stock. 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 and its Form 10-Q for the first quarter of 2005, 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.

CONTACT: IMPAX Laboratories, Inc.
Barry R. Edwards, CEO, 215-933-0323 Ext. 4360
Arthur A. Koch, Jr., CFO, 215-933-0351
Larry Hsu, Ph.D., President, 510-476-2000 Ext. 1111
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
Bruce Voss, 310-691-7100

SOURCE: IMPAX Laboratories, Inc.