EX. 99.1
[LOGO]
COMPANY CONTACTS: INVESTOR RELATIONS CONTACTS:
IMPAX Laboratories, Inc. Lippert/Heilshorn & Associates, Inc.
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Barry R. Edwards, CEO Kim Sutton Golodetz (kgolodetz@lhai.com)
(215) 933-0323 Ext. 4360 (212) 838-3777
Larry Hsu, Ph.D. President Bruce Voss (bvoss@lhai.com)
(510) 476-2000 Ext. 1111 (310) 691-7100
Cornel C. Spiegler, CFO www.lhai.com
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(215) 289-2220 Ext. 1706
www.impaxlabs.com
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Draft 1 -Semi-Final
2/24/05
IMPAX FILES MOTION TO INTERVENE AS DEFENDANT IN CASE RELATED TO
GENERIC ALLEGRA-D(R)
HAYWARD, CALIF. (FEBRUARY 28, 2005) -- IMPAX LABORATORIES, INC. (NASDAQ: IPXL)
today announced that it has filed a motion in the United States District Court
for the District of Columbia to intervene as a defendant in a lawsuit by Barr
Laboratories, Inc. against the United States Food and Drug Administration (FDA).
Earlier this month, Barr Laboratories, a subsidiary of Barr Pharmaceuticals Inc.
(NYSE: BRL), brought suit against the FDA in an attempt to prevent the agency
from granting final approval to IMPAX's Abbreviated New Drug Application (ANDA)
for its Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended
Release Tablets, a generic version of Allegra-D(R). IMPAX was granted tentative
approval of the generic product in February 2004. Aventis Pharmaceuticals
markets Allegra-D for the treatment of the symptoms associated with seasonal
allergic rhinitis. According to NDCHealth, U.S. sales of Allegra-D were
approximately $425 million in the 12 months ended December 31, 2004.
"In effect, Barr is attempting to rewrite the rules of the Hatch-Waxman
amendments, which were designed to increase competition in the pharmaceutical
industry," said Barry R. Edwards, IMPAX Laboratories' Chief Executive Officer.
"Under the laws governing Paragraph IV certifications, both IMPAX and Barr are
eligible to share 180 days of exclusivity because we believe both companies were
"first to file" Paragraph IV Certifications for different patents listed for
Allegra-D. Because Barr's suit against the FDA potentially affects us, we have
requested that IMPAX be allowed to intervene as a defendant in this matter to
protect our rights."
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.
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