Impax Laboratories Confirms Patent Challenge Relating to Fenoglide® 40 and 120 mg Tablets
April 29 2010 - 9:00AM
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® (fenofibrate)
tablets, 40 and 120 mg.
Impax filed its Abbreviated New Drug Application (ANDA) for a
generic version of Fenoglide® 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® 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® 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® 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.
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