December 2, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today announced
that the United States Food and Drug Administration (FDA) has accepted the Company's
filing of an Abbreviated New Drug Application (ANDA) for a generic version of
Tricor® (Fenofibrate) 160 mg Tablets. Abbott Laboratories, Inc. markets
Tricor for the treatment of 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.
IMPAX's application includes a certification under Paragraph IV of the Hatch-Waxman
Amendments stating the Company's belief that its Fenofibrate Tablet product
does not infringe certain Abbott listed patents on Tricor Tablets. FDA's acceptance
of the IMPAX ANDA for filing means that the Agency has made a threshold determination
that the application is sufficiently complete to permit a substantive review.
Larry Hsu, Ph.D., President and Chief Operating Officer of IMPAX, said, "This
is another demonstration of the flexibility of our drug delivery technologies
and our R&D team's capability to develop new products. We remain on track
to reach the high end of our goal of six to eight new product filings in 2002."
IMPAX has 19 ANDAs pending at the FDA that address more than $5.7 billion in
U.S. branded product sales for the 12 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 a previously approved
ANDA, have received tentative approval from the FDA.
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.