Company Awarded 180-day Market ExclusivityHAYWARD, Calif., Oct 26, 2006 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S.
Food and Drug Administration (FDA) has granted approval of the
Company's Abbreviated New Drug Application (ANDA) for a generic
version of Colestid(R) Tablets (Colestipol Hydrochloride Tablets) 1
gram. The FDA also awarded the Company first-to-file status and
180-day market exclusivity for this product under Paragraph IV of the
Hatch-Waxman amendments. Pharmacia and Upjohn Company (Pfizer) markets
the 1 gram Tablet as adjunctive therapy to diet for the reduction of
elevated serum total and LDL-C in patients with primary
hypercholesterolemia (elevated LDL-C) who do not respond adequately to
diet. Total brand sales of Colestid(R) Tablets 1 gram in the U.S. were
$20 million for the 12 months ended August 31, 2006, according to
Wolters Kluwer Health.
"This is our third ANDA approval this year," commented Larry Hsu,
Ph.D., IMPAX's President and Chief Executive Officer. "We are looking
forward to our Global Pharmaceuticals division marketing our generic
Colestid Tablets very shortly."
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 IMPAX's stock, IMPAX's delay
in filing its 2004 Form 10-K, its Form 10-Q for each of the first
three quarters of 2005, its Form 10-K for 2005, and its Form 10-Q for
each of the first two quarters of 2006, 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.
Larry Hsu,
Ph.D., President & CEO,
510-476-2000 Ext. 1111
Arthur Koch,
CFO,
215-933-0351
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz,
212-838-3777
[email protected]
Bruce Voss,
310-691-7100
[email protected]
www.lhai.com