HAYWARD, Calif., Feb 27, 2004 (BUSINESS WIRE) -- IMPAX
Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug
Administration (FDA) has granted tentative approval to the Company's
Abbreviated New Drug Application (ANDA) for its generic version of
Allegra(R)-D (Fexofenadine Hydrochloride and Pseudoephedrine
Hydrochloride 60mg/120mg) Extended Release Tablets. Aventis
Pharmaceuticals (Aventis) 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 $459 million in
the 12 months ended December 31, 2003.
Final approval is contingent upon the earlier of the resolution of
pending patent-infringement litigation brought by Aventis against
IMPAX, or the expiration of the 30-month stay process under the
Hatch-Waxman Amendments; and the expiration of any generic marketing
exclusivity. Final approval is also dependent upon FDA's evaluation of
any new information subsequent to this tentative approval.
IMPAX Laboratories previously announced FDA acceptance of the
Company's ANDA filing for Fexofenadine Hydrochloride and
Pseudoephedrine Hydrochloride 60mg/120mg Extended Release Tablets in
February 2002 and commented on the filing of a lawsuit by Aventis
alleging patent infringement relating to the ANDA in April 2002. The
litigation with Aventis is still ongoing.
"This tentative approval is our second ANDA approval this year,"
said Larry Hsu, Ph.D., President of IMPAX Laboratories. "We are
pleased to see our new product pipeline continue to progress through
FDA."
IMPAX currently has 20 applications pending at the FDA, including
six tentatively approved, which address over $6.8 billion in U.S.
branded product sales for the 12 months ended December 31, 2003.
Fifteen 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.
SOURCE: IMPAX Laboratories, Inc.
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
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz (kgolodetz@lhai.com)
212-838-3777
Bruce Voss (bvoss@lhai.com)
310-691-7100
www.lhai.com
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