HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it
has initiated a challenge of the patents listed in the Orange Book in
connection with Fentora® (fentanyl buccal tablets, 100 mcg, 200 mcg, 400
mcg, 600 mcg and 800 mcg).
Impax filed its Abbreviated New Drug Application (ANDA) containing a
paragraph IV certification for a generic version of Fentora® with
the U.S. Food & Drug Administration (FDA). Following receipt of the
notice from 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 November 18, 2011, Cephalon, Inc. and CIMA Labs, Inc. filed suit for
patent infringement against Impax Laboratories, Inc. in the District of
Delaware. 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, intends to commercialize the product.
Fentora® is used to treat "breakthrough" cancer pain that is not
controlled by other medicines. According to Wolters Kluwer Health, U.S.
sales of Fentora® were approximately $159 million for the twelve months
ending September 2011.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (“Impax”) 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, including the statements under the
heading “2011 Financial Outlook,” 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 and results of
operations, the ability to maintain an effective system of internal
control over financial reporting, fluctuations in revenues and operating
income, the ability to successfully develop and commercialize
pharmaceutical products, reductions or loss of business with any
significant customer or a reduction in sales of any significant product,
the impact of competition, the ability to sustain profitability and
positive cash flows, any delays or unanticipated expenses in connection
with the operation of the Taiwan facility, the effect of foreign
economic, political, legal and other risks on operations abroad, 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, the
ability to successfully conduct clinical trials, reliance on alliance
and collaboration agreements, the availability of raw materials, the
ability to comply with legal and regulatory requirements governing the
pharmaceuticals and healthcare industries, the regulatory environment,
the ability to protect the Company’s intellectual property, 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.