- Marketing to Begin Immediately -
HAYWARD, Calif.--(BUSINESS WIRE)--Nov. 10, 2006--IMPAX
Laboratories, Inc. (OTC:IPXL) 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 a generic version of
Ditropan(R) XL, Extended-release Tablets, 15 mg (Oxybutynin Chloride
Extended-release Tablets 15 mg). The FDA also awarded the Company
first-to-file status and 180-day market exclusivity for this product.
Alza Pharmaceuticals markets Ditropan XL for the treatment of urge
urinary incontinence. U.S. sales of Ditropan XL 15 mg were
approximately $58 million in the 12 months ended August 31, 2006,
according to Wolters Kluwer Health.
The Company's version of generic Ditropan XL 15 mg 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.
"We are very pleased to now have eight FDA approvals this year and
look forward to working with our partner on the launch of our generic
version of 15 mg Ditropan XL," said Larry Hsu, President and Chief
Executive Officer of IMPAX Laboratories. "We had expected this
approval following the September 2006 appeals court ruling in our
favor in a patent infringement suit brought against us by Alza," he
added.
The Company noted that it continues to have tentative approval for
its 5 mg and 10 mg versions of generic Ditropan XL. Conversion of the
5 mg and 10 mg strengths from tentative approval to final approval is
contingent upon the expiration of any generic marketing exclusivity by
other applicants. Final approval also is dependent upon FDA's
evaluation of any new information subsequent to the tentative
approval. Wolters Kluwer Health estimates that U.S. sales of all
dosage forms of Ditropan XL Extended-release Tablets were
approximately $338 million in the 12 months ended August 31, 2006.
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: Company Contacts:
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,
kgolodetz@lhai.com
212-838-3777
Bruce Voss, bvoss@lhai.com
310-691-7100
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.