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HAYWARD, Calif.(BUSINESS WIRE)
Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that
it has initiated a challenge of the patents listed by Abbott
Laboratories in connection with its TRICOR (fenofibrate) tablets, 48 mg
and 145 mg.
Impax filed its Abbreviated New Drug Application (ANDA?) containing a
Paragraph IV certification for a generic version of TRICOR 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 October 29, 2009, Abbott Laboratories and Laboratoires Fournier S.A.
filed suit for patent infringement against Impax in the United States
District Court for the District of New Jersey. This action formally
initiates the patent challenge process under the Hatch-Waxman Act.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's
generic division, will commercialize the products.
TRICOR is indicated as adjunctive therapy to diet to reduce elevated
LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult
patients with primary hypercholesterolemia or mixed dislipidemia
(Fredrickson Type IIa and IIb). TRICOR is also indicated as adjunctive
therapy to diet for treatment of adult patients with
hypertriglyceridemia (Fredrickson Type IV and V hyperlipidemia).
According to Wolters Kluwer Health, aggregate U.S. sales of TRICOR were
approximately $1.5 billion for the twelve-month period ending August
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 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 and suspension of trading in Impax's stock, Impax's failure
to file any periodic reports subsequent to its quarterly report on Form
10-Q for the quarter ended September 30, 2004, the SEC's revocation of
the registration of Impax's common stock under section 12 of the
Securities Exchange Act of 1934, the actual time that will be required
to,file a registration statement on Form 10 with respect to such stock,
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.
Impax Laboratories, Inc.
Mark Donohue
Sr. Director
Investor Relations
215-933-3526
www.impaxlabs.com
Source: Impax Laboratories, Inc.
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