Jan. 30, 2003--IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that
the U.S. Food and Drug Administration (FDA) has granted final approval to the
Company's Abbreviated New Drug Application (ANDA) for a generic version of Rilutek®
(Riluzole 50mg) tablets. Aventis markets Rilutek® for the treatment of amyotrophic
lateral sclerosis (ALS), also known as Lou Gehrig's disease. Approval followed
the expiration of Aventis' Orphan Drug Exclusivity on December 12, 2002. According
to IMS Health, U.S. sales of Rilutek were $35 million for the 12 months ended
September 30, 2002.
The Company also announced that on December 12, 2002, the District Court of
Wilmington, Delaware, granted the preliminary injunction motion brought by Aventis
on October 15, 2002, to forestall IMPAX's entry into this market. The Company
had sought a declaratory judgment action seeking a judicial declaration of invalidity
against Aventis regarding patent 5,527,814 that was only recently listed by
Aventis in the FDA "Orange Book." Litigation is currently scheduled
for trial in October 2003.
"We are pleased that the FDA has granted final approval of the Company's
generic version of Rilutek and look forward to making a lower-cost product available
to patients suffering from ALS," commented Larry Hsu, Ph.D., President
of IMPAX Laboratories. "Despite the granting of the preliminary injunction
to Aventis, we remain optimistic about the eventual outcome of this patent validity
challenge."
After this approval, IMPAX has 20 ANDAs pending at the FDA, including four
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.