Jan. 27, 2003--IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that
Abbott Laboratories has filed a lawsuit against the Company in the federal district
court in Delaware alleging patent infringement related to IMPAX's filing of
an Abbreviated New Drug Application (ANDA) for a generic version of cholesterol
drug, Tricor® Tablets.
Tricor is a treatment for very high serum triglyceride levels. U.S. sales of
Tricor 160 mg Tablets were approximately $354 million in the 12 months ended
September 30, 2002, according to IMS data. The FDA accepted for review IMPAX's
application to market a generic version of Abbott's Tricor (Fenofibrate) 160-mg
tablets in December 2002. IMPAX's submission includes a Paragraph IV certification
stating the product does not infringe upon Abbott's Tricor patents.
Barry R. Edwards, Co-Chief Executive Officer of IMPAX Laboratories, commented,
"This type of lawsuit is standard practice in the industry and we are not
surprised by Abbott's lawsuit. It is solely intended to delay our generic product
to the market. The FDA accepted our ANDA for Tricor in December of 2002 and
we believe our product will provide an effective and more economical alternative
in the marketplace. We will proceed accordingly to defend our application."
IMPAX has 21 ANDAs pending at the FDA, including five tentatively approved,
that address more than $6.1 billion in U.S. branded product sales for the 12
months ended September 30, 2002. Fourteen of these filings were made under Paragraph
IV of the Hatch-Waxman Amendments.
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: www.impaxlabs.com.