Impax Laboratories Settles Pending Litigation for FLOMAX®
October 07 2009 - 7:00AM
Business Wire
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced
that it has reached agreement with Astellas Pharma Inc. and
Boehringer Ingelheim Pharmaceuticals, Inc. to settle pending U.S.
litigation with regard to US Patent No. 4,703,063 for FLOMAX®
(generic name: tamsulosin hydrochloride) capsules through the entry
of a consent judgment confirming the validity and infringement of
the patent. FLOMAX® is a treatment for the functional symptoms of
benign prostatic hyperplasia.
As a result of this settlement, the case will be terminated by
the consent judgment. The settlement of the litigation
provides Impax with the opportunity to launch a generic tamsulosin
hydrochloride product on March 2, 2010, prior to the expiration of
pediatric exclusivity. Further terms of the settlement will
not be disclosed.
According to Wolters Kluwer Health, U.S. sales of Flomax® 0.4mg
capsules were approximately $1.9 billion for the 12 months ended
August 31, 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.
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