HAYWARD, Calif., Feb 28, 2005 (BUSINESS WIRE) -- 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 lawsuit 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.
SOURCE: IMPAX Laboratories, Inc.
Company Contacts:
IMPAX Laboratories, Inc.
Barry R. Edwards, 215-933-0323 Ext. 4360
Larry Hsu, Ph.D., 510-476-2000 Ext. 1111
Cornel C. Spiegler, 215-289-2220 Ext. 1706
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