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: www.impaxlabs.com.