HAYWARD, Calif., Apr 29, 2010 (BUSINESS WIRE) --Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that it has
initiated a challenge of a patent listed by Shionogi Pharma, Inc. in
connection with its Fenoglide(R) (fenofibrate) tablets, 40 and
120 mg.
Impax filed its Abbreviated New Drug Application (ANDA) for a generic
version of Fenoglide(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 and the listing of the patent
in the FDA Publication, Approved Drug Products with Therapeutic
Equivalence Evaluations (commonly referred to as the "the Orange
Book"), Impax submitted a paragraph IV certification to FDA and notified
the New Drug Application holder and patent owner of its certification.
On April 28, 2010, Shionogi Pharma, Inc. and LifeCycle Pharma A/S 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 date
of the paragraph IV certification, 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.
Fenoglide(R) 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 hyperlipidemia or mixed
dyslipidemia. Fenoglide(R) is also indicated as adjunctive
therapy to diet for treatment of adult patients with
hypertriglyceridemia. According to Wolters Kluwer Health, U.S. sales of
Fenoglide(R) were approximately $36 million for the
twelve-month period ending February 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.
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
215-933-3526
www.impaxlabs.com