IMPAX's Fourth Tentative ANDA Approval This Year
July 22, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today announced
that the U.S. Food and Drug Administration (FDA) has granted tentative approval
to the Company's Abbreviated New Drug Application (ANDA) for a generic version
of Rilutek® (Riluzole 50mg) tablets. Aventis Pharmaceutical Products, Inc.
markets Rilutek® for the treatment of amyotrophic lateral sclerosis (ALS),
also known as Lou Gehrig's disease. According to IMS Health, U.S. sales of Rilutek
were $35 million for the 12 months ended March 31, 2002.
Final FDA approval is contingent upon the expiration of Orphan Drug Exclusivity
on December 12, 2002, resolution of the patent litigation that IMPAX has initiated
against Aventis regarding a patent recently listed by Aventis in the FDA "Orange
Book," as well as FDA's evaluation of any new information subsequent to
this tentative approval.
"This is our fourth ANDA tentative approval this year, and we are pleased
with the progress we are making in our development and commercialization strategy,"
said Larry Hsu, Ph.D., President and Chief Operating Officer of IMPAX Laboratories.
"The development of our generic version of Rilutek® is consistent with
our strategy to develop niche products we believe will have limited competition.
Upon final approval, we anticipate that our Global Pharmaceuticals division
will market the product."
IMPAX currently has 17 ANDA filings pending at the FDA that address more than
$9 billion in 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 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.