HAYWARD, Calif.--(BUSINESS WIRE)--Nov. 19, 2007--IMPAX
Laboratories, Inc. (OTC:IPXL) today confirmed that Endo
Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co. have
filed a lawsuit against the Company in the United States District
Court for the District of Delaware alleging patent infringement
related to IMPAX's filing of an Abbreviated New Drug Application
(ANDA) with the U.S. Food and Drug Administration (FDA) for
oxymorphone hydrochloride extended-release tablets CII, a generic
version of Opana(R) ER.
IMPAX's submission includes a Paragraph IV certification stating
the Company believes its product does not infringe U.S. Patent Nos.
7,276,250, 5,662,933 and 5,958,456 or that the patents are invalid or
unenforceable. The suit alleges infringement of U.S. Patent Nost.
5,662,933 and 5,958,456 and also seeks declaratory judgment that the
court to declare that the Paragraph IV Certification Notices that
IMPAX served on Endo and Penwest are null, void and of no legal effect
and that, therefore, the Court has no subject matter jurisdiction over
the patent infringement claims.
"We believe that our Paragraph IV certification for generic Opana
ER was proper, that our product does not infringe any valid,
enforceable patent, and, as such, we will vigorously defend this
lawsuit. Furthermore, we believe that the rescission of our ANDA by
the FDA was inappropriate and we are continuing to work with the FDA
to allow our ANDA to stand," said Larry Hsu, Ph.D., president and
chief executive officer of IMPAX Laboratories.
Endo Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co.
manufacture and market Opana ER for the treatment of moderate to
severe pain. According to Wolters Kluwer Health, U.S. sales of Opana
ER tablets were approximately $48.8 million in the 12 months ended
September 30th, 2007.
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 2004 Form 10-K,
its Form 10-Q for each of the first three quarters of 2005, 2006, and
2007, its Form 10-K for 2005 and 2006, the actual time that will be
required to complete the filing of IMPAX's delinquent periodic
reports, 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.
CONTACT: 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
SOURCE: IMPAX Laboratories, Inc.