IMPAX's First Tentative Approval of an ANDA with a Paragraph IV Filing
February 21, 2002 -- IMPAX Laboratories, Inc. (Nasdaq: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 Tricor® (Fenofibrate Capsules), Micronized. Tricor is marketed by Abbott
Laboratories, Inc. (NYSE:ABT - news) for the treatment of very high serum triglyceride
levels. According to IMS Health, U.S. sales of the capsule form of the prescription
lipid-regulating agent were over $235 million in 2001. Abbott has announced
the discontinuation of the capsule form and its replacement by a new tablet
form.
The tentative approval covers Fenofibrate Capsules (Micronized) 67 mg, 134
mg and 200 mg capsules. Final approval is contingent upon the earlier of (1)
the settlement of pending patent-infringement litigation brought by Abbott against
IMPAX, or (2) the expiration of the 30-month stay process under the Hatch-Waxman
Amendments; and the expiration of any generic marketing exclusivity. Final approval
is also dependent upon FDA's evaluation of any new information subsequent to
this tentative approval.
IMPAX Laboratories announced FDA acceptance of the Company's ANDA filing for
Fenofibrate in July 2000, and commented on the filing of a lawsuit by Abbott
Laboratories alleging patent infringement relating to the ANDA in September
2000.
``We are delighted to receive this notification for Fenofibrate Capsules (Micronized),
our first tentative approval of an ANDA containing a Paragraph IV certification,''
said Larry Hsu, Ph.D., President and Chief Operating Officer. ``Upon resolution
of the tentative approval provisions, our generic version of Tricor® will
be marketed in the U.S. by our Global Pharmaceuticals division.''
IMPAX currently has 15 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 and one of these now has 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.