IMPAX Settles Patent Suit and Signs Marketing and Promotion Agreements with Shire

January 19, 2006

HAYWARD, Calif.--(BUSINESS WIRE)--Jan. 19, 2006--IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has reached a settlement with an affiliate of Britain's Shire Pharmaceuticals Group Plc ("Shire") covering all patent litigation between the parties related to Adderall XR(R) (mixed amphetamine salts). Under the settlement, IMPAX will be permitted to market generic versions of Adderall XR in the United States no later than January 1, 2010. In certain situations, such as the launch of another generic version of Adderall XR, IMPAX may be permitted to enter the market as Shire's authorized generic. IMPAX will pay Shire a royalty from its generic sales of Adderall XR.

Adderall XR is marketed by Shire for attention deficit hyperactivity disorder (ADHD). According to NDCHealth, U.S. gross sales of Adderall XR tablets were approximately $912 million in the 12 months ended November 30, 2005.

Larry Hsu, Ph.D., IMPAX's President, commented, "This agreement is a win-win for both companies as we are now able to resolve the uncertainty of the outcome of litigation and prevent the suit from becoming an even more costly and time consuming dispute."

In a separate agreement, IMPAX will promote Carbatrol(R) (carbamazepine extended release capsules), Shire's product for the treatment of epilepsy beginning around July 2006. The general framework of the agreement calls for IMPAX to receive approximately $40 million over three years to detail physicians with the product and related information. IMPAX has agreed to perform a minimum number of such activities over the three year period. Also under the agreement, IMPAX is entitled to certain incentive payments based on prescription growth. Other terms of the agreement are confidential and were not disclosed.

Carbatrol had U.S. gross sales of $78 million for the twelve months ended November 30, 2005, according to NDCHealth.

IMPAX initially plans to recruit and deploy approximately 66 to 70 specialty sales representatives, either directly or through a contract sales arrangement with a third party, or a combination of both. The primary target market for Carbatrol of approximately 8,300 neurologists in the U.S. overlaps with the Company's target market for Vadova(TM) (carbidopa and levodopa). IMPAX's branded product Vadova is actively under review by the U.S. Food and Drug Administration and is expected to be approved this year, thus IMPAX intends to achieve synergies in its overall sales and marketing costs.

Commenting on the agreement, Mr. Barry R. Edwards, IMPAX's CEO, said, "With two important CNS products to market to physicians available at approximately the same time, IMPAX plans to establish a position in the branded products market category from the day we enter the market. We believe this will enhance our reputation in the marketplace, as well as lower our overall sales and marketing costs on a per-product basis. We are very pleased to have earned Shire's confidence and we are looking forward to a mutually rewarding, long-term relationship."

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 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. 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's for the first three quarters 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, 215-933-0360
Larry Hsu, Ph.D., 510-476-2000, Ext. 1111
Arthur Koch, 215-933-0351
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz (
Bruce Voss (

SOURCE: IMPAX Laboratories, Inc.