HAYWARD, Calif., Jun 01, 2007 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S.
District Court for the Southern District of New York has rendered a
decision in IMPAX's patent litigation with AstraZeneca involving
IMPAX's Abbreviated New Drug Applications (ANDA) for generic versions
of Prilosec(R) (omeprazole) delayed release capsules, 10 mg, 20 mg and
40 mg. The court found two of AstraZeneca's patents valid and
infringed by IMPAX's product. The court has asked for additional
submissions on the form of the relief, if any, in view of the fact
that Astra had previously dropped its damages claim against IMPAX in
order to avoid a jury trial and that the patents had expired on April
20, 2007.
Furthermore, while the two AstraZeneca patents at issue expired on
April 20, 2007, AstraZeneca claims that it is still entitled to
pediatric exclusivity until October 20, 2007 and that the FDA should
revoke IMPAX's final approval until expiry of the pediatric
exclusivity period. IMPAX does not believe that AstraZeneca is
entitled to such relief.
Pursuant to a June 2001 strategic alliance agreement, Teva
Pharmaceutical Industries Ltd. (Nasdaq:TEVA) has U.S. marketing rights
to IMPAX's omeprazole delayed release capsules. In September and
November 2004, Teva commenced sales of IMPAX's 20 and 10 mg strengths,
respectively.
About IMPAX Laboratories, Inc.
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 markets 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.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are
forward-looking in nature and express the beliefs and expectations of
management. Such statements are based on current expectations and
involve a number of known and unknown risks and uncertainties that
could cause IMPAX's future results, performance or achievements to
differ significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Such risks
and uncertainties include, but are not limited to, possible adverse
effects resulting from the delisting of and suspension of trading in
IMPAX's stock, the SEC proceeding to determine whether to suspend or
revoke the registration of IMPAX's securities under section 12 of the
Securities Exchange Act, IMPAX's delay in filing its periodic reports
subsequent to its Form 10-Q for the third quarter of 2004, IMPAX's
ability to obtain sufficient capital to fund its operations, the
difficulty of predicting FDA filings and approvals, consumer
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, IMPAX's ability to successfully
develop and commercialize pharmaceutical products, IMPAX's reliance on
key strategic alliances, the uncertainty of patent litigation, the
availability of raw materials, the regulatory environment, dependence
on patent and other protection for innovative products, exposure to
product liability claims, fluctuations in operating results and other
risks detailed from time to time in IMPAX's filings with the
Securities and Exchange Commission. Forward-looking statements speak
only as to the date on which they are made, and IMPAX undertakes no
obligation to update publicly or revise any forward-looking statement,
regardless of whether new information becomes available, future
developments occur or otherwise.
SOURCE: IMPAX Laboratories, Inc.
Company Contacts:
IMPAX Laboratories, Inc.
Larry Hsu, Ph.D. President & CEO, 510-476-2000 ext. 1111
Arthur Koch, CFO, 215-933-0351
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com