HAYWARD, Calif., Jan 15, 2010 (BUSINESS WIRE) -- Impax Laboratories, Inc.(NASDAQ:IPXL) today confirms that
it has initiated a challenge of patents listed by Daiichi Sankyo, Inc.
in connection with its WELCHOL(R) (Colesevelam HCl) tablets, 625 mg.
Impax filed its Abbreviated New Drug Application ("ANDA") containing a
paragraph IV certification for a generic version of WELCHOL(R) with the
U.S. Food & Drug Administration ("FDA"). Following receipt of the notice
from the FDA that Impax's ANDA had been accepted for filing, Impax
notified the New Drug Application holder and patent owners of its
paragraph IV certification.
On January 14, 2010, Daiichi Sankyo, Inc. and Genzyme Corporation filed
suit for patent infringement against Impax in the United States District
Court for the District of Delaware. This action formally initiates the
patent challenge process under the Hatch-Waxman Act. Based on the filing
date of the ANDA, the Company believes that it is the first to file an
ANDA with a paragraph IV certification and expects to be entitled to 180
days of market exclusivity.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's
generic division, will commercialize the products.
WELCHOL(R) is indicated as an adjunct to diet and exercise to reduce
elevated low-density lipoprotein cholesterol (LDL-C) in adults with
primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in
combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA)
reductase inhibitor (statin), reduce LDL-C levels in boys and
postmenarchal girls, 10 to 17 years of age, with heterozygous familial
hypercholesterolemia as monotherapy or in combination with a statin
after failing an adequate trial of diet therapy, and improve glycemic
control in adults with type 2 diabetes mellitus. According to Wolters
Kluwer Health, U.S. sales of WELCHOL(R) were approximately $308 million
for the twelve-month period ending November 2009.
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 the Company'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; ability to timely file periodic reports required by
the Exchange Act; ability to maintain an effective system of internal
control over financial reporting; ability to sustain profitability and
positive cash flows; ability to maintain sufficient capital to fund
operations; any delays or unanticipated expenses in connection with the
construction of our Taiwan facility; ability to successfully develop and
commercialize pharmaceutical products; the uncertainty of patent
litigation; consumer acceptance and demand for new pharmaceutical
products; the impact of competitive products and pricing; the difficulty
of predicting Food and Drug Administration filings and approvals;
inexperience in conducting clinical trials and submitting new drug
applications; reliance on key alliance agreements; the availability of
raw materials; the regulatory environment; exposure to product liability
claims; fluctuations in operating results and other risks described in
our periodic reports filed 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.
Company Contacts:
Mark Donohue
Sr. Director, Investor Relations
(215) 933-3526
www.impaxlabs.com