HAYWARD, Calif.--(BUSINESS WIRE)--May 17, 2004--IMPAX
Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food
and Drug Administration (FDA) has granted final approval to the
Company's Abbreviated New Drug Application (ANDA) for
Carbidopa/Levodopa Extended Release Tablets, its generic version of
Sinemet(R) CR tablets. Bristol-Myers Squibb (NYSE:BMY) markets Merck &
Co.'s (NYSE:MRK) Sinemet CR exclusively in the U.S. for the treatment
of Parkinsonism. According to NDCHealth, U.S. prescription sales of
Sinemet CR and the one currently marketed generic equivalent were $126
million in the 12 months ended February 29, 2004. IMPAX's Global
Pharmaceuticals division will begin marketing the product shortly.
"As only the second generic approval, this illustrates our
strategy of applying our drug delivery technology to compounds with
limited competition," said Larry Hsu, Ph.D., IMPAX's President. "We
are also pleased to note that this is our sixth approval this year."
IMPAX currently has 16 applications pending at the FDA, including
five tentatively approved, which address approximately $5.3 billion in
U.S. market sales for the 12 months ended February 29, 2004 as
reported in NDCHealth data. Twelve of these filings were made under
Paragraph IV of the Hatch-Waxman Amendments.
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:
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, 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.
Barry R. Edwards, 215-289-2220 Ext. 1771
Larry Hsu, Ph.D., 510-476-2000 Ext. 1111
Cornel C. Spiegler, 215-289-2220 Ext. 1706
www.impaxlabs.com
or
Lippert/Heilshorn & Associates, Inc. (Investor Relations)
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.