HAYWARD, Calif., Mar 07, 2006 (BUSINESS WIRE) -- 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 for Vadova(R)
(carbidopa/levodopa) tablets. The letter cites several deficiencies in
the application including observations resulting from an FDA
inspection of the contract laboratory employed by IMPAX to perform
bioequivalence studies. IMPAX is seeking a meeting with the FDA to
review the comments in detail. The Company is unable to predict
whether, and if so when Vadova might be available for commercial
launch. Commenting on this news, Dr. Larry Hsu, IMPAX's president
stated, "We are disappointed with this development and we will work
diligently with the FDA and the contract laboratory to provide the
additional data required for approval as fast as prudently possible.
We followed the study design described in our Investigational New Drug
application and we believe the results obtained not only present a
valuable product for the patient but are within the regulatory
requirements."
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 intends to market 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:
o 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 and 2005 Form 10-K's and its Form 10-Q's for the
first three quarters of 2005, 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.
IMPAX Laboratories, Inc.
Barry R. Edwards, 215-933-0360
Larry Hsu, Ph.D., 510-476-2000 ext. 1111
Arthur Koch, 215-933-0351
www.impaxlabs.com
or
Lippert/Heilshorn & Associates, Inc. (Investor Relations)
Kim Sutton Golodetz, 212-838-3777
[email protected]
Bruce Voss, 310-691-7100
[email protected]
www.lhai.com