PARSIPPANY, N.J., May 24, 2012 /PRNewswire/ -- Watson
Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its
subsidiary, Watson Laboratories, Inc., filed an Abbreviated New
Drug Application (ANDA) with the U.S. Food and Drug Administration
(FDA) seeking approval to market Testosterone Gel, 1%. Watson's 1%
testosterone gel product is a generic version of Auxilium
Pharmaceuticals, Inc.'s Testim® 1%. Testim®1% is indicated for
testosterone replacement therapy in males for conditions associated
with a deficiency or absence of endogenous testosterone.
Auxilium Pharmaceuticals, Inc. and FCB I LLC filed suit against
Watson on May 23, 2012 in the United
States District Court for the District of New Jersey seeking to prevent Watson from
commercializing its 1% testosterone gel product prior to the
expiration of certain U.S. patents. The lawsuit was filed
under the provisions of the Hatch-Waxman Act, resulting in a stay
of final FDA approval of Watson's ANDA for up to 30
months from the date the plaintiffs received notice of Watson's
ANDA filing or until final resolution of the matter before the
court, whichever occurs sooner, subject to any other
exclusivities.
For the twelve months ending March 31,
2012, Testim® had total U.S. sales of approximately
$260 million according to IMS Health
data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is an integrated global
specialty pharmaceutical company. The Company is engaged in the
development, manufacturing, marketing and distribution of generic
pharmaceuticals and specialized branded pharmaceutical products
focused on Urology and Women's Health. The Company is also
developing biosimilar products in Women's Health and
Oncology. Additionally, Watson distributes generic and
branded pharmaceuticals through its Anda, Inc. distribution
business. Watson has operations in many of the world's established
and growing international markets.
For press release and other company information,
visit Watson Pharmaceuticals' Web site
at http://www.watson.com.
Forward-Looking Statement
Statements contained in this press release that refer to
non-historical facts are forward-looking statements that reflect
Watson's current perspective of existing information as of the date
of this release. It is important to note that Watson's goals and
expectations are not predictions of actual performance. Actual
results may differ materially from Watson's current expectations
depending upon a number of factors, risks and uncertainties
affecting Watson's business. These factors include, among others,
the difficulty of predicting the timing or outcome of product
development efforts, including FDA and other regulatory
agency approvals and actions, if any; the difficulty of predicting
the timing and outcome of the pending patent litigation; the impact
of competitive products and pricing; the timing and success of
product launches; difficulties or delays in manufacturing; the
availability and pricing of third party sourced products and
materials; successful compliance with FDA and other
governmental regulations applicable to Watson and its third party
manufacturers' facilities, products and/or businesses; changes in
the laws and regulations,
including Medicare and Medicaid, affecting among
other things, pricing and reimbursement of pharmaceutical products;
and such other risks and uncertainties detailed in Watson's
periodic public filings with the Securities and Exchange
Commission, including but not limited to Watson's Quarterly Report
on Form 10-Q for the quarter ended March 31, 2012 and
Watson's Annual Report on Form 10-K for the year
ended December 31, 2011. Except as expressly required by law,
Watson disclaims any intent or obligation to update these
forward-looking statements.
Testim® is a registered trademark of Auxilium Pharmaceuticals,
Inc.
CONTACTS:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Charlie
Mayr
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(862)
261-8030
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http://photos.prnewswire.com/prnh/20100121/LA41294LOGO )
SOURCE Watson Pharmaceuticals, Inc.