Teva Settles Track 1 Opioid Cases and Reaches Agreement on Framework to Settle Remaining Litigation
2019年10月22日 - 2:53AM
ビジネスワイヤ(英語)
Teva Pharmaceutical Industries Ltd. and its affiliates today
announced a settlement agreement with both Cuyahoga and Summit
counties of Ohio. The settlement resolves the counties’ claims and
removes Teva from the Track 1 opioid litigation. Under the terms of
the settlement, the Company will provide the two counties with the
critical opioid treatment medication buprenorphine naloxone
(sublingual tablets), known by the brand name Suboxone®, valued at
$25 million (at wholesale acquisition cost) and distributed over
three years to help in the care and treatment of people suffering
from addiction (to be allocated at each county’s discretion) and a
cash payment in the amount of $20 million, to be paid over three
years.
The Company also confirms that there is an agreement in
principle with a group of attorneys general from North Carolina,
Pennsylvania, Tennessee and Texas, as well as certain defendants,
for a global settlement framework. The framework is designed to
provide a mechanism by which the Company attempts to seek
resolution of remaining potential and pending opioid claims by both
the states and political subdivisions. Under this agreement, Teva
would donate buprenorphine naloxone (sublingual tablets), in
quantities of up to the amount needed to meet the majority of the
currently estimated U.S. patient need over the next 10 years, with
a value of approximately $23 billion (at wholesale acquisition
cost). Buprenorphine naloxone is the primary drug used to treat
opioid addiction. The Teva product donation will significantly
contribute to the care and treatment of people suffering from
addiction and assist impacted communities. Teva would also provide
a cash payment of up to $250 million over 10 years.
The Company is pleased to positively contribute to solving the
nationwide opioid epidemic. Teva has consistently committed to
complying with all laws and regulations regarding its manufacture
and sale of opioids. Neither settlement includes an admission of
liability.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that 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 successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; competition for our specialty products, especially
COPAXONE®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; the uncertainty of commercial
success of AJOVY® or AUSTEDO®; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics, including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; the increase in the
number of competitors targeting generic opportunities and seeking
U.S. market exclusivity for generic versions of significant
products; price erosion relating to our products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: failure to
effectively execute our restructuring plan announced in December
2017; uncertainties related to, and failure to achieve, the
potential benefits and success of our senior management team and
organizational structure; harm to our pipeline of future products
due to the ongoing review of our R&D programs; our ability to
develop and commercialize additional pharmaceutical products;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; compliance with
sanctions and other trade control laws; manufacturing or quality
control problems, which may damage our reputation for quality
production and require costly remediation; interruptions in our
supply chain; disruptions of our or third party information
technology systems or breaches of our data security; the failure to
recruit or retain key personnel; variations in intellectual
property laws that may adversely affect our ability to manufacture
our products; challenges associated with conducting business
globally, including adverse effects of political or economic
instability, major hostilities or terrorism; significant sales to a
limited number of customers in our U.S. market; our ability to
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions;
implementation of a new enterprise resource planning system that,
if deficient, could materially and adversely affect our operations
and/or the effectiveness of our internal controls; and our
prospects and opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including: costs
and delays resulting from the extensive governmental regulation to
which we are subject; the effects of reforms in healthcare
regulation and reductions in pharmaceutical pricing, reimbursement
and coverage; increased legal and regulatory action in connection
with public concern over the abuse of opioid medications in the
U.S.; governmental investigations into selling and marketing
practices; potential liability for patent infringement; product
liability claims; increased government scrutiny of our patent
settlement agreements; failure to comply with complex Medicare and
Medicaid reporting and payment obligations; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and 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;
and other factors discussed in this press release, in our
Quarterly Report on Form 10-Q for the second quarter of 2019 and in
our Annual Report on Form 10-K for the year ended December 31,
2018, including in the sections captioned "Risk Factors” and
“Forward Looking Statements.” 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 statements or other
information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
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IR Contacts United States Kevin C. Mannix (215)
591-8912
Israel Ran Meir 972 (3) 926-7516
PR Contacts United States Kelley Dougherty (973)
658-0237
Israel Yonatan Beker 972 (54) 888 5898
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