Final Approval for 10 and 20 mg Strengths, Tentative Approval for 40 mg Strength
November 11, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: 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 its 10 and 20 mg
strengths and tentative approval for its 40 mg strength of Omeprazole Delayed
Release Capsules, a generic version of Prilosec®. AstraZeneca markets Prilosec
for the treatment of duodenal/gastric ulcers and GERD (gastro-esophageal reflux
disease). According to IMS Health, U.S. sales of Prilosec were approximately
$4.2 billion for the twelve months ended June 30, 2002.
Final FDA approval of the Company's 40 mg strength of Omeprazole Delayed Release
Capsules is contingent upon the earlier of (1) the resolution of pending patent-infringement
litigation brought by AstraZeneca 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.
"We are pleased with FDA's approval of our Omeprazole ANDA. This product
is representative of our development strategy of applying our formulation and
development expertise to create significant generic opportunities," said
Larry Hsu, Ph.D., President and Chief Operating Officer of IMPAX Laboratories.
"This is our seventh ANDA approval this year including those tentatively
approved by the FDA."
"Our lawsuit with AstraZeneca is still pending in the courts," said
Barry R. Edwards, Co-Chief Executive Officer. "We are awaiting word from
the judge regarding the timing of our case moving forward. We remain confident
in our defenses with respect to AstraZeneca's patents."
After this approval, IMPAX has 19 ANDAs pending at the FDA that address more
than $5.6 billion in U.S. branded product sales for the twelve months ended
June 30, 2002. Eleven of these filings were made under Paragraph IV of the Hatch-Waxman
Amendments. Four of these 19 pending ANDAs, as well as one strength of one approved
ANDA, 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.