HAYWARD, Calif.--(BUSINESS WIRE)--Sep. 21, 2009--
Impax Laboratories, Inc. today confirms that it has initiated a
challenge of the patents listed by Galderma Laboratories, L.P. in
connection with its ORACEA® (doxycycline) delayed-release capsules, 40
mg.
Impax filed its Abbreviated New Drug Application (“ANDA”) containing a
paragraph IV certification for a generic version of ORACEA® 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 owners of its
paragraph IV certification.
On September 18, 2009, The Research Foundation of State University of
New York; New York University; Galderma Laboratories Inc.; and Galderma
Laboratories, L.P. 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.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s
generic division, will commercialize the product.
ORACEA® is indicated for the treatment of only inflammatory lesions
(papules and pustules) of rosacea in adult patients. According to
Wolters Kluwer Health, U.S. sales of ORACEA® were approximately $104
million for the twelve-month period ending July 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 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; 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 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 described in
our Annual Report on Form 10-K for the year ended December 31, 2008.
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, 215-933-3526
Sr.
Director Investor Relations
www.impaxlabs.com