HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 7, 2006--IMPAX
Laboratories, Inc. (OTC:IPXL) announced that the U.S. Court of Appeals
for the Federal Circuit upheld a lower court ruling in favor of IMPAX
in its defense of a lawsuit brought by Alza Corporation, a Johnson &
Johnson (NYSE:JNJ) unit. The suit alleged patent infringement related
to IMPAX's filing of an Abbreviated New Drug Application (ANDA) for a
generic version of Ditropan(R) XL (Oxybutynin Chloride) tablets, 5, 10
and 15 mg. Alza Pharmaceuticals markets Ditropan XL for the treatment
of urge urinary incontinence. U.S. sales of Ditropan XL were
approximately $350 million in the 12 months ended May 31, 2006,
according to Wolters Kluwer Health.
"We are pleased that yet another court has seen through Alza's
attempt to delay the availability to patients of a lower priced
alternative to the branded drug," commented Larry Hsu, Ph.D.,
president of IMPAX. "We received tentative approval for Oxybutynin
Chloride 5, 10 and 15 mg Extended Release Tablets in February 2005.
Final approval is now dependent on the U.S. Food and Drug
Administration's (FDA) resolution of a Citizen's Petition brought by
Johnson & Johnson, and on the expiration of any marketing exclusivity.
We believe that we were first to file an ANDA on the 15 mg dosage
form, and thus could have 180 days of marketing exclusivity following
final FDA approval."
The Company's version of generic Ditropan XL is one of 12 products
covered under its strategic alliance entered into in June 2001 with a
subsidiary of Teva Pharmaceutical Industries Ltd. Following final FDA
approval and the Company's decision to launch, Teva is expected to
market the product.
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 IMPAX's stock, IMPAX's delay
in filing its 2004 Form 10-K, its Form 10-Q for each of the first
three quarters of 2005, its Form 10-K for 2005, and its Form 10-Q for
each of the first two quarters of 2006, 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,
215-933-0360
Larry Hsu, Ph.D.,
510-476-2000, Ext. 1111
Arthur Koch,
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.