-Marketing to Begin Immediately-
HAYWARD, Calif.--(BUSINESS WIRE)--May 9, 2007--IMPAX Laboratories,
Inc. (OTC: IPXL) ("IMPAX" or "the Company") today announced that the
U.S. Food and Drug Administration (FDA) has granted final approval of
the Company's Abbreviated New Drug Application (ANDA) for generic
versions of Ditropan(R) XL, (Oxybutynin Chloride) 5 mg and 10 mg
Extended-release Tablets. Alza Pharmaceuticals markets Ditropan XL for
the treatment of urge urinary incontinence. U.S. sales of both the
branded and generic 5 mg and 10 mg dosage forms were approximately
$233 million in the 12 months ended March 2007, according to Wolters
Kluwer Health.
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. (Nasdaq: TEVA). Teva
plans to begin marketing the product immediately.
"This is our second FDA approval this year and we look forward to
working with our partner on the launch of our generic version of 5 mg
and 10 mg Ditropan XL," said Larry Hsu, Ph.D., IMPAX's president and
chief executive officer. "We are pleased to add these dosage forms to
our 15 mg version, which received approval and 180-day marketing
exclusivity last November," Dr. Hsu added.
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 and suspension of trading in
IMPAX's stock, the SEC proceeding to determine whether to suspend or
revoke the registration of IMPAX's securities under section 12 of the
Securities Exchange Act, 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, its Form 10-Q for each of the first three quarters of
2006, and its Form 10-K for 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.