HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 2, 2005--IMPAX
Laboratories, Inc. (OTC:IPXL) today announced that Alza Corporation
and McNeil-PPC, Inc. have filed a complaint against the Company in the
United States District Court for the District of Delaware, alleging
patent infringement related to IMPAX's filing for a generic version of
Concerta(r). The plaintiffs have not served IMPAX with the complaint.
IMPAX has submitted its 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
Concerta(r) tablets do not infringe the listed patents or that the
listed patents are invalid or unenforceable.
Concerta is marketed by McNeil Consumer & Specialty
Pharmaceuticals, a division of Johnson & Johnson as a once-daily
treatment for attention deficit disorder/attention deficit
hyperactivity disorder. According to NDCHealth, U.S. sales of Concerta
tablets were approximately $770 million in the 12 months ended July,
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 common stock trading through the "pink
sheets" and making required filings with the Securities and Exchange
Commission and otherwise satisfying Nasdaq listing standards in order
to regain the listing of its common stock. 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 for the first quarter 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, CEO, 215-933-0323 Ext. 4360
Arthur A. Koch, Jr., CFO, 215-933-0351
Larry Hsu, Ph.D., President, 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
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.