HAYWARD, Calif., Mar 15, 2010 (BUSINESS WIRE) --
Impax Laboratories, Inc.(NASDAQ: IPXL) today confirms
that it has initiated a challenge of the patent listed by Abbott
Laboratories and Fournier Laboratories Ireland Ltd. in connection with
its TRILIPIX(R) (choline fenofibrate) delayed-release capsules,
135 mg and 45 mg.
Impax filed its Abbreviated New Drug Application ("ANDA") containing a
paragraph IV certification for a generic version of TRILIPIX(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 owner of its
paragraph IV certification.
On March 12, 2010, Abbott Laboratories and Fournier Laboratories Ireland
Ltd. 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. 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.
TRILIPIX(R) helps reduce cholesterol and triglycerides (fatty
acids) in the blood. According to Wolters Kluwer Health, U.S. sales of
TRILIPIX(R) were approximately $276 million across both
strengths for the twelve month period ending January 2010.
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, Philadelphia and Taiwan
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, the effect of current economic conditions on the
Company's industry, business, financial position, results of operations
and market value of its common stock, the ability to maintain an
effective system of internal control over financial reporting,
fluctuations in revenues and operating income, reductions or loss of
business with any significant customer, the impact of competitive
pricing and products and regulatory actions on the Company's products,
the ability to sustain profitability and positive cash flows, the
ability to maintain sufficient capital to fund operations, any delays or
unanticipated expenses in connection with the operation of the Taiwan
facility, the ability to successfully develop and commercialize
pharmaceutical products, the uncertainty of patent litigation, consumer
acceptance and demand for new pharmaceutical products, the difficulty of
predicting Food and Drug Administration filings and approvals, the
inexperience of the Company in conducting clinical trials and submitting
new drug applications, reliance on key alliance and collaboration
agreements, the availability of raw materials, the ability to comply
with legal and regulatory requirements governing the healthcare
industry, the regulatory environment, exposure to product liability
claims and other risks described in the Company's 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 Contact:
Mark Donohue
Sr. Director Investor Relations and Corporate Communications
(215) 933-3526
www.impaxlabs.com