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Teva Pharmaceutical Industries Ltd.
TEVA announced today that its
subsidiary Teva Pharmaceuticals USA, Inc. has entered into a settlement with
Pfizer related to Teva's generic version of Celebrex® (celecoxib) 50, 100, 200
and 400 mg capsules in the United States. Under the terms of the settlement,
Teva may launch its generic versions in December, 2014, or earlier under
certain circumstances. Teva has received tentative approval from the U.S. Food
and Drug Administration (FDA) for all strengths and believes that it is
first-to-file on at least the 100, 200 and 400 mg capsules. Sales of Celebrex®
were $2.2 billion in the U.S. according to IMS data as of December, 2013.
About Teva
Teva Pharmaceutical Industries Ltd.
TEVA is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic drugs as
well as innovative and specialty pharmaceuticals and active pharmaceutical
ingredients. Headquartered in Israel, Teva is the world's leading generic drug
maker, with a global product portfolio of more than 1,000 molecules and a
direct presence in approximately 60 countries. Teva's branded businesses focus
on CNS, oncology, pain, respiratory and women's health therapeutic areas as
well as biologics. Teva currently employs approximately 45,000 people around
the world and reached $20.3 billion in net revenues in 2013.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation
Reform Act of 1995:
This release contains forward-looking statements, which are based on
management's current beliefs and expectations and involve a number of known
and unknown risks and uncertainties that could cause our future results,
performance or achievements to differ significantly from the results,
performance or achievements expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to such
differences include risks relating to: our ability to develop and
commercialize additional pharmaceutical products; competition for our
innovative products, especially COPAXONE^®(including competition from
orally-administered alternatives, as well as from potential purported generic
equivalents); the possibility of material fines, penalties and other sanctions
and other adverse consequences arising out of our ongoing FCPA investigations
and related matters; our ability to achieve expected results from the research
and development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent and during
the timeframe intended by our cost reduction program; our ability to identify
and successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the extent to
which any manufacturing or quality control problems damage our reputation for
quality production and require costly remediation; our potential exposure to
product liability claims that are not covered by insurance; increased
government scrutiny in both the U.S. and Europe of our patent settlement
agreements; our exposure to currency fluctuations and restrictions as well as
credit risks; the effectiveness of our patents, confidentiality agreements and
other measures to protect the intellectual property rights of our specialty
medicines; the effects of reforms in healthcare regulation and pharmaceutical
pricing, reimbursement and coverage; governmental investigations into sales
and marketing practices, particularly for our specialty pharmaceutical
products; uncertainties related to our recent management changes; the effects
of increased leverage and our resulting reliance on access to the capital
markets; any failure to recruit or retain key personnel, or to attract
additional executive and managerial talent; adverse effects of political or
economical instability, major hostilities or acts of terrorism on our
significant worldwide operations; interruptions in our supply chain or
problems with internal or third-party information technology systems that
adversely affect our complex manufacturing processes; significant disruptions
of our information technology systems or breaches of our data
security; competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
competition for our specialty pharmaceutical businesses from companies with
greater resources and capabilities; decreased opportunities to obtain U.S.
market exclusivity for significant new generic products; potential liability
in the U.S., Europe and other markets for sales of generic products prior to a
final resolution of outstanding patent litigation; any failures to comply with
complex Medicare and Medicaid reporting and payment obligations; the impact of
continuing consolidation of our distributors and customers; significant
impairment charges relating to intangible assets and goodwill; potentially
significant increases in tax liabilities; the effect on our overall effective
tax rate of the termination or expiration of governmental programs or tax
benefits, or of a change in our business; variations in patent laws that may
adversely affect our ability to manufacture our products in the most efficient
manner; environmental risks; and other factors that are discussed in our
Annual Report on Form 20-F for the year ended December 31, 2013 and in our
other filings with the U.S. Securities and Exchange Commission.
Forward-looking statements speak only as of the date on which they are made
and we assume no obligation to update or revise any forward-looking statement,
whether as a result of new information, future events or otherwise.
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