IMPAX Provides Update on Strategic Alliance with Teva

November 26, 2002

November 26, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today announced that a trigger for the optional product in its strategic alliance with a subsidiary of Teva Pharmaceutical Industries Ltd. has occurred, and that Teva has exercised its option.

In the strategic alliance agreement, signed in June 2001, IMPAX granted Teva exclusive United States marketing rights and an option to acquire exclusive marketing rights in Canada, the European Union and Israel for the following:

  • Five IMPAX products pending approval at the U.S. Food and Drug Administration (FDA) and an option to acquire exclusive marketing rights to one additional IMPAX product pending approval at the FDA (Tier 1 Products)
  • Three products under development by IMPAX (Tier 2 Products)
  • Three products to be mutually agreed upon (Tier 3 Products)

The Tier 1 Products are: Loratadine/Pseudoephedrine Sulfate 12 hour Extended Release Tablets (generic of Claritin® D 12-Hour), Loratadine/Pseudoephedrine Sulfate 24 hour Extended Release Tablets (generic of Claritin® D 24-Hour), Loratadine Orally Disintegrating Tablets (generic of Claritin® Reditabs), Bupropion Extended Release Tablets (generic of Wellbutrin® SR Tablets), Bupropion Extended Release Tablets (generic of Zyban® Tablets) and Omeprazole Delayed Release Capsules (generic of Prilosec® Capsules).
The recent tentative and final approvals received by IMPAX from the FDA for its Omeprazole Delayed Release Capsules ANDA triggered Teva's exercise of its option to acquire exclusive U.S. marketing rights for this product.

"This strategic alliance with Teva is one of the key elements in our commercial strategy, and we are pleased they have exercised this option," stated Barry R. Edwards, IMPAX Laboratories Co-Chief Executive Officer. "The lawsuit with AstraZeneca relating to our Omeprazole Delayed Release Capsules is still pending in the courts. While we remain confident in our defenses with respect to AstraZeneca's patents, we currently have no immediate plans to launch our product."

The Company also reported that subsequent to signing the agreement with Teva, the Tier 3 Products have been agreed upon, IMPAX has filed ANDAs with the FDA for three additional products and continues with development work on the remaining three products in Tier 2 and Tier 3. The Tier 2 and Tier 3 Products have not been disclosed.

IMPAX has 19 ANDAs pending at the FDA that address more than $5.7 billion in U.S. branded product sales for the twelve months ended September 30, 2002. Eleven of these filings were made under Paragraph IV of the Hatch-Waxman Amendments. Four of these 19 pending ANDAs, as well as one strength of one approved ANDA, have received tentative approval from the FDA.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 35 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are in North America and Europe. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.

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 niche 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. 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: