HAYWARD, Calif., Oct 04, 2007 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC:IPXL) today confirmed reports that
it has provided notice to Endo Pharmaceuticals Holdings Inc. and
Penwest Pharmaceuticals Co. that it has submitted an Abbreviated New
Drug Application (ANDA) for oxymorphone hydrochloride extended-release
tablets CII, generic of Opana(R) ER, to the U.S. Food and Drug
Administration (FDA). IMPAX's ANDA, as amended, contains a Paragraph
IV certification stating that the Company believes its product does
not infringe US Patent No. 7,276,250, or that the patent is invalid or
unenforceable. Following an acceptance for filing by the FDA the
Company was informed by the agency that it has rescinded its initial
acceptance. IMPAX believes that the rescission is inappropriate and is
working with the FDA to correct any deficiencies of the ANDA.
Endo Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co.
manufacture and market Opana ER for the treatment of moderate to
severe pain. According to Wolters Kluwer Health, U.S. sales of Opana
ER tablets were approximately $42.9 million in the 12 months ended
August 31, 2007.
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 and 2006,
its Form 10-K for 2005 and 2006, and its Form 10-Q for the first
quarter of 2007, the actual time that will be required to complete the
filing of IMPAX's delinquent periodic reports, 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.
SOURCE: IMPAX Laboratories, Inc.
Company Contacts:
IMPAX Laboratories, Inc.
Larry Hsu, Ph.D. President & CEO
510-476-2000, Ext. 1111
Arthur A. Koch, Jr. 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