HAYWARD, Calif.--(BUSINESS WIRE)--Oct. 24, 2005--IMPAX
Laboratories, Inc. (OTC:IPXL) today announced that an affiliate of
Britain's Shire Pharmaceuticals Group Plc ("Shire") has filed a
complaint against the Company in the United States District Court for
the Southern District of New York, alleging patent infringement
related to a third patent for Adderall XR. The Company has not yet
been served with the complaint. IMPAX has submitted its ANDA filing
with the U.S. Food and Drug Administration (FDA) under Paragraph IV of
the Hatch-Waxman Amendments, stating that it believes its generic
versions of Adderall XR tablets do not infringe the two patents listed
in the FDA's "Orange Book" or that those two listed patents are
invalid or unenforceable. The Company is currently in litigation with
Shire in the United States District Court for the District of Delaware
regarding Shire's claim that the Company's ANDA infringes the two
Orange Book listed patents, with a trial date scheduled for February,
2006. The patent at issue in this recent complaint was not listed in
the FDA "Orange Book" and therefore was not included in the Company's
previous Paragraph IV certification, however, the Company believes
that its generic versions of Adderall XR tablets do not infringe this
third patent or that this patent is also invalid or unenforceable.
Adderall XR is marketed by Shire for attention deficit
hyperactivity disorder (ADHD). According to NDCHealth, U.S. sales of
Adderall XR tablets were approximately $770 million in the 12 months
ended July 31, 2005.
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 intends to market 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. In particular, the forward-looking statements include
statements about IMPAX's estimated timelines and new application
filing goals. 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 IMPAX's stock, IMPAX's delay
in filing its 2004 Form 10-K and its Form 10-Q's for the first two
quarters of 2005, 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.
Barry R. Edwards, 215-933-0323 Ext. 4360
Arthur A. Koch, Jr., 215-933-0351
Larry Hsu, Ph.D., 510-476-2000 Ext. 1111
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.