HAYWARD, Calif.--(BUSINESS WIRE)--Mar. 20, 2009--
Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that Warner
Chilcott Laboratories Ireland Limited, Warner Chilcott Company, Inc.,
Warner Chilcott (US), LLC, and Mayne Pharma International Pty. Ltd.
filed suit for patent infringement against Impax in the United States
District Court for the District of New Jersey in response to Impax’s
challenge of the patent listed in connection with Doryx® (doxycycline
hyclate) delayed-release tablets, 150 mg.
Impax filed its Abbreviated New Drug Application (ANDA) containing a
paragraph IV certification for a generic version of Doryx® 150 mg 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. Based on the filing date of the ANDA, the
Company expects to be entitled to 180-day market exclusivity.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s
generic division, will commercialize the products.
Doryx® is a tetracycline-class antibacterial indicated for rickettsial
infections, sexually transmitted infections, respiratory tract
infections, specific bacterial infections, ophthalmic infections,
anthrax, including inhalational anthrax (post-exposure), alternative
treatment for selected infections when penicillin is contraindicated,
adjunctive therapy in acute intestinal amebiasis and severe acne, and
prophylaxis of malaria. According to Wolters Kluwer Health, U.S. sales
of Doryx® 150 mg were approximately $29 million in the 12 months ended
January 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; ability to timely file periodic reports required by
the Exchange Act; ability to maintain an effective system of internal
control over financial reporting; ability to sustain profitability and
positive cash flows; ability to maintain sufficient capital to fund
operations; any delays or unanticipated expenses in connection with the
construction of our Taiwan facility; ability to successfully develop and
commercialize pharmaceutical products; the uncertainty of patent
litigation; consumer acceptance and demand for new pharmaceutical
products; the impact of competitive products and pricing; the difficulty
of predicting Food and Drug Administration (“FDA”) filings and
approvals; inexperience in conducting clinical trials and submitting new
drug applications; reliance on key alliance agreements; the availability
of raw materials; the regulatory environment; exposure to product
liability claims; fluctuations in operating results and other risks
detailed from time to time in our 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.
Source: Impax Laboratories, Inc.
Impax Laboratories, Inc.
Mark Donohue, Sr. Director Investor
Relations
215-933-3526
www.impaxlabs.com