PARSIPPANY, N.J., Dec. 28,
2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI)
today confirmed that Actavis, Inc., which was acquired by Watson in
October, has filed an Abbreviated New Drug Application (ANDA) with
the U.S. Food and Drug Administration (FDA) seeking approval to
market bortezomib. Actavis' ANDA product is a generic version
of Millennium Pharmaceuticals' Velcade ® (bortezomib),
which is a proteasome inhibitor, for intravenous or subcutaneous
administration, approved for the treatment of patients with
multiple myeloma and patients with mantle cell lymphoma who have
received at least one prior therapy.
Millennium filed suit against Actavis on December 21, 2012, in the U.S. District Court for
the District of Delaware seeking
to prevent Actavis from commercializing its ANDA 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 Actavis' ANDA for up to 30
months from the date the plaintiffs received notice of Actavis'
ANDA filing or until final resolution of the matter before the
court, whichever occurs sooner, subject to any other
exclusivities.
For the 12 months ending October 31,
2012, Velcade® had total U.S. sales of
approximately $740 million according
to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. (NYSE: WPI) is a global,
integrated specialty pharmaceutical company focused on developing,
manufacturing and distributing generic, brand and biosimilar
products. The Company has global and U.S. headquarters in
Parsippany, New Jersey, USA, and
international headquarters in Zug, Switzerland.
Watson is the world's third-largest generics prescription drug
manufacturer, with more than 750 products marketed globally through
operations in more than 60 countries. Watson's global branded
pharmaceutical business develops and markets products principally
in Urology and Women's Health, and is committed to developing
and marketing biosimilars products in Women's Health, Oncology and
other therapeutic categories. In addition, Watson is the
fourth-largest U.S. generic pharmaceutical product distributor
through its Anda, Inc. business, and also develops and out-licenses
generic pharmaceutical products outside of the U.S. through its
Medis third-party business. Watson has announced that it will
adopt a new global name – Actavis – effective in 2013.
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 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 September 30, 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.
Velcade® is a registered trademark of Millennium
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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SOURCE Watson Pharmaceuticals, Inc.