Company's 11th Paragraph IV ANDA Filing
August 22, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: 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 40 mg Tablets. Purdue Pharma
markets Oxycontin for the management of moderate to severe pain. U.S. sales
of Oxycontin Extended Release 40 mg Tablets were approximately $520 million
in the 12 months ended June 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 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.
The Company announced in February 2002 that its ANDA for a generic version
of Oxycontin® (Oxycodone HCl) Extended Release 80 mg Tablets had been accepted
by the FDA. In April 2002 IMPAX announced that Purdue Pharma had filed suit
in the United States District Court for the Southern District of New York alleging
patent infringement on that dosage. U.S. sales of Oxycontin Extended Release
40 mg and 80 mg Tablets were approximately $1 billion in the 12 months ended
June 30, 2002, according to IMS data.
"This is the 11th acceptance of a Paragraph IV ANDA by the FDA in the
Company's short history and the third this year," said Larry Hsu, Ph.D.,
President and Chief Operating Officer. "In line with our goal of six to
eight ANDA filings in 2002, we expect to file at least three more ANDAs during
the remainder of this year."
IMPAX currently has 17 ANDAs pending at the FDA that address more than $9 billion
in 2001 U.S. branded product sales. Ten of these filings were made under Paragraph
IV of the Hatch-Waxman Amendments, and four of these 17 ANDAs now 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.