HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 29, 2005--IMPAX
Laboratories, Inc. (OTC:IPXL) announced that it has prevailed in its
defense of a lawsuit brought by Alza Corporation, a Johnson & Johnson
(NYSE:JNJ) unit, alleging 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.
"In February of this year, we received tentative approval from the
U.S. Food and Drug Administration on our ANDA for the 5, 10 and 15 mg
dosage forms of our generic version of Ditropan XL," commented Larry
Hsu, Ph.D., President of IMPAX. "We believe that we were first to file
on the 15 mg dosage form."
According to NDCHealth, sales of Ditropan XL tablets were $395
million, with the 15 mg accounting for $66 million, in the 12 months
ended July 2005.
The lawsuit against IMPAX was brought in the United States
District Court, Northern District of California. In a previous
stipulation, Alza and IMPAX agreed to be bound by the decision as to
patent validity in a case involving the same patent brought by Alza
against Mylan Laboratories alleging patent infringement on the generic
versions of Ditropan XL manufactured by Mylan. Mylan announced on
September 28, 2005 that a West Virginia federal district court ruled
that Mylan's version does not infringe Alza's patent and that the
patent is invalid. Because the patent was found to be invalid, under
the stipulation IMPAX will be entitled to judgment in its favor. Final
FDA approval of our ANDA, however, may be subject to FDA's resolution
of an August 2005 petition filed by Johnson & Johnson to block
approval.
Alza has also announced that it intends to appeal this decision.
In this event, we believe the IMPAX and Mylan cases will be heard
together on appeal.
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.