HAYWARD, Calif.--(BUSINESS WIRE)--Jan. 30, 2008--IMPAX
Laboratories, Inc. (OTC:IPXL) today announced that it has received a
non-approvable letter from the U.S. Food and Drug Administration (FDA)
concerning its new drug application (NDA) and subsequent submissions
for Vadova(R) (carbidopa/levodopa extended release) tablets. The FDA's
action was primarily based on unresolved issues relating to product
nomenclature and its belief of a likelihood of medication errors
resulting from confusion of Vadova with other marketed forms of
carbidopa/levodopa. The NDA, which was originally filed in April 2005,
was deemed non-approvable in March 2006. IMPAX subsequently filed
responses addressing the FDA's earlier concerns, which included
clinical pharmacology and chemistry, manufacturing and control
components. These concerns were not cited in the most recent
non-approvable letter.
"We are very disappointed with the receipt of this letter, and we
continue to believe that Vadova represents a significant improvement
in the choices available to patients in the treatment of the symptoms
of Parkinson's disease," said Larry Hsu, Ph.D., president and chief
executive officer of IMPAX Laboratories. "We will continue to pursue
discussions with the FDA concerning this decision and we are
evaluating all options for the product."
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, 2006, and
2007, its Form 10-K for 2005 and 2006, 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.
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, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.