HAYWARD, Calif.--(BUSINESS WIRE)--Oct. 7, 2009--
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.
Source: Impax Laboratories, Inc.
Impax Laboratories, Inc.
Mark Donohue, 215-933-3526
Sr.
Director Investor Relations
www.impaxlabs.com