HAYWARD, Calif.--(BUSINESS WIRE)--Nov. 22, 2006--IMPAX
Laboratories, Inc. (OTC: IPXL) ("IMPAX" or "the Company") today
announced that the United States Court of Appeals for the Federal
Circuit ruled that the district court had erred in deciding, after
trial, that the patent relating to the use of riluzole in treating ALS
(Pat. No. 5,527,814) was valid and has vacated that decision and
remanded it back to the district court for further proceedings related
to the validity issue of anticipation. On December 12, 2002, in an
earlier decision, the United States District Court for the District of
Delaware granted a preliminary injunction motion brought by Aventis on
October 15, 2002, which delayed IMPAX's entry into the market. IMPAX's
ANDA for its generic version of Rilutek(R) (riluzole) 50mg tablets was
approved on January 29, 2003. IMPAX expects to request that the
injunction preventing the Company from launching its generic version
of Rilutek(R) be lifted upon return of the case to the lower court.
Rilutek(R), marketed by Aventis for the treatment of amyotrophic
lateral sclerosis (ALS), also known as Lou Gehrig's disease, had U.S.
sales of approximately $37 million for the 12 months ended August 31,
2006, according to Wolters Kluwer Health.
"We are pleased that the Federal Circuit decided to remand this
case back to the lower court as we believe that it is important to
make an affordable alternative available to patients suffering from
ALS," commented Larry Hsu, Ph.D., President and CEO of IMPAX
Laboratories. "We continue to remain optimistic about the eventual
outcome of this patent validity challenge."
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.
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.