Company's Ninth Paragraph IV ANDA Filing
February 26, 2002 -- IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced
that the U.S. Food and Drug Administration (FDA) has accepted the Company's
filing of an Abbreviated New Drug Application (ANDA) for a generic version of
Oxycontin® (Oxycodone HCl) Extended Release 80 mg Tablets. Purdue Pharma
markets Oxycontin for the management of moderate to severe pain. U.S. sales
of Oxycontin Extended Release 80 mg Tablets were over $400 million in 2001.
IMPAX's application includes a certification under Paragraph IV of the Hatch-Waxman
Amendments stating the Company's belief that its product does not infringe Purdue
Pharma L.P.'s listed patents on Oxycontin Extended Release Tablets. The FDA's
acceptance of the ANDA for filing means that the agency has determined that
the application is sufficiently complete so as to permit a review.
``This is our ninth filing of an ANDA under Paragraph IV with the FDA, and
was our eighth filing in calendar year 2001,'' said Larry Hsu, Ph.D., President
and Chief Operating Officer. ``With this filing, we continue to advance the
pipeline of products that will drive our sales growth in the years to come.''
IMPAX currently has fifteen ANDA filings pending at the FDA that address more
than $8 billion in U.S. branded product sales. Nine of these filings were made
under Paragraph IV of the Hatch-Waxman Amendments, one of which has received
tentative approval from 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.