Impax Laboratories Confirms Patent Challenge Relating to ORACEADelayed-Release Capsules, 40mg
HAYWARD, Calif.--(Business Wire)--
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.
Impax Laboratories, Inc.
Mark Donohue, 215-933-3526
Sr. Director Investor Relations
www.impaxlabs.com
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