HAYWARD, Calif.--(BUSINESS WIRE)--April 14, 2008--IMPAX
Laboratories, Inc. (OTC:IPXL) today announced that the Company has
begun work to develop a next-generation carbidopa/levodopa product.
The decision follows a meeting with the U.S. Food and Drug
Administration (FDA) to address the Agency's previously disclosed
concerns over product nomenclature and the potential for medication
errors that might result from confusion of the Company's Vadova(R)
tablets with other marketed forms of carbidopa/levodopa. Following an
extensive analysis by the Company and discussion with the FDA, IMPAX
has decided to cease work with the current formulation of the product.
Michael Nestor, president of IMPAX's Branded Products Division,
commented, "Our R&D team, headed by Dr. Suneel Gupta, is at work on a
next-generation carbidopa/levodopa product that will benefit from the
regulatory experience and formulation experience we have gained
through this process. In addition, we are prioritizing our other
pipeline candidates. Our sales force has been establishing meaningful
relationships in the marketplace since mid-2006, and we look to
capitalize on those relationships with additional product offerings.
We also are actively seeking in-licensing opportunities and other
alliances to continue these valuable relationships. We remain fully
committed to developing products that address critical patient needs
in neurology and central nervous system indications."
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, 2006 and 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.
CONTACT: IMPAX Laboratories, Inc.
Larry Hsu, Ph.D., President & CEO
510-476-2000, x1111
or
Arthur A. Koch, Jr., Sr. VP & CFO
215-933-0351
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.