JERUSALEM--(BUSINESS WIRE)--Apr. 17, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE: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. (NYSE: 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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
Israel
Tomer Amitai, 972
(3) 926-7656
or
United States
Ran Meir, 215-591-3033
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974