HAYWARD, Calif.--(BUSINESS WIRE)--March 5, 2007--IMPAX
Laboratories, Inc. (OTC:IPXL) ("IMPAX" or "the Company") announced
today that it has settled its patent litigation suit with Biovail
Laboratories International SRL related to IMPAX's version of Bupropion
Hydrochloride Extended-Release Tablets, generic of Wellbutrin(R) XL,
150 mg and 300 mg. The settlement was made pursuant to an agreement
among the Company, Biovail, a subsidiary of Teva Pharmaceutical
Industries Ltd., and Anchen Pharmaceuticals.
The litigation will be dismissed with Biovail granting to Teva an
exclusive license to market the IMPAX 300 mg strength product for the
period from December 13, 2006 until June 13, 2007, and non-exclusive
thereafter. Under their Strategic Alliance agreement, Teva launched
IMPAX's 300 mg product in December 2006 pursuant to an exclusivity
transfer agreement with Anchen, who was awarded first-to-file
exclusivity for both the 300mg and 150mg dosage strengths.
With respect to the 150 mg product, IMPAX has amended its
Strategic Alliance agreement with Teva, such that Teva will market
Anchen's product during Anchen's 180-day period of exclusivity and pay
a royalty to IMPAX rather than any profit share. Following this
180-day period, IMPAX will market the 150 mg dosage strength either
through Teva, or on its own should Teva elect to continue marketing
Anchen's product. The settlement agreement also includes license
grants for the 150mg product, which will commence in 2008 or earlier
under certain specified circumstances.
"This lawsuit has consumed financial resources and management
time, and we are very pleased to put this to rest," said Larry Hsu,
Ph.D., president and chief executive officer of IMPAX.
Wellbutrin XL is marketed by GlaxoSmithKline for the treatment of
depression. The 150 mg and 300 mg versions together had U.S. sales in
excess of $1.8 billion for the 12 months ended December 31, 2006,
according to Wolters Kluwer Health.
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 three 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
Lippert/Heilshorn & Associates, Inc.
Investor Relations:
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.