August 26, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today announced
that Judge Marilyn H. Patel of the United States District Court for the Northern
District of California has issued an order granting IMPAX's Motion for Summary
Judgment of Non-Infringement regarding the Company's Abbreviated New Drug Applications
(ANDAs) for Wellbutrin SR® and for Zyban®. GlaxoSmithKline markets Wellbutrin
SR® for the treatment of depression, and markets Zyban® for the cessation
of smoking. According to IMS Health, for the 12 months ended June 30, 2002, U.S.
sales of Wellbutrin SR® were $1.33 billion, and U.S. sales of Zyban® were
$83 million.
"We are very pleased that the U.S. District Court for the Northern District
of California has granted our Motion for Summary Judgment of Non-Infringement
regarding our ANDAs for Wellbutrin SR® and Zyban®," commented Barry
R. Edwards, Co-Chief Executive Officer of IMPAX Laboratories. "This legal
victory, combined with the recent decision of the United States District Court
of New Jersey to grant our Motion for Summary Judgment and declare portions
of the Schering-Plough Corporation U.S. Patent No. 4,659,716 invalid as they
relate to our generic Claritin® ANDAs, has made August 2002 an excellent
month for IMPAX," continued Mr. Edwards. "These decisions positively
impact five of our 10 ANDA filings with Paragraph IV certification."
IMPAX currently has 17 ANDA filings pending at the FDA that address more than
$9 billion in U.S. branded product sales. Ten of these filings were made under
Paragraph IV of the Hatch-Waxman Amendments, and four of the 17 ANDAs have received
tentative approval from the FDA.
IMPAX Laboratories, Inc. is a technology focused 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.