Teva Announces Launch of 1% Sodium Hyaluronate in the United States
2019年7月1日 - 9:30PM
ビジネスワイヤ(英語)
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the launch of 1% Sodium Hyaluronate. The product received
approval from the Center for Devices and Radiological Health of the
U.S. Food and Drug Administration. 1% Sodium Hyaluronate is
indicated for the treatment of pain in osteoarthritis (OA) of the
knee in patients who have failed to respond adequately to
conservative non-pharmacologic therapy and simple analgesics (e.g.,
acetaminophen).
The safety and effectiveness of 1% Sodium Hyaluronate was
evaluated in a double-blind, prospective, multi-site, randomized,
three-arm, parallel group, pivotal trial in adults. The primary
objective of the trial was to evaluate the effectiveness of three
weekly intra-articular injections of 2 mL of 1% Sodium Hyaluronate
into the knee as compared to placebo for the treatment of pain in
subjects with OA. The safety and effectiveness of 1% Sodium
Hyaluronate was also compared with Euflexxa®1 (1% sodium
hyaluronate).
Individuals receiving 1% Sodium Hyaluronate reported a
statistically significant decrease in pain scores from baseline to
week 26 compared to individuals in the placebo group. Overall,
treatment-emergent adverse events were similar across all three
study arms with the most common being pain in the knee or at the
injection site. Effectiveness scores were similar between 1% Sodium
Hyaluronate and Euflexxa®.
“The launch of 1% Sodium Hyaluronate is a great example of using
the expertise within Teva to bring together skills from both our
generic and specialty business,” said Brendan O’Grady, EVP and Head
of North America Commercial. “We are proud to bring an additional
offering to the physicians and patients seeking treatment options
for OA knee pain.”
1% Sodium Hyaluronate is supplied in a 3 mL disposable prefilled
syringe containing 2 mL of 1% sodium hyaluronate, and packaged as
three syringes to a carton. For details on ordering call Teva
Customer Service at 1-888-838-2872.
About 1% Sodium
Hyaluronate
1% sodium hyaluronate is indicated for the treatment of pain in
osteoarthritis (OA) of the knee in patients who have failed to
respond adequately to conservative non-pharmacologic therapy and
simple analgesics (e.g., acetaminophen).
IMPORTANT SAFETY INFORMATION
Do not use 1% sodium hyaluronate to treat patients who have a
known hypersensitivity to hyaluronan preparations. Do not use to
treat patients with knee joint infections or to treat patients with
infections or skin disease in the area of the injection site.
Do not concomitantly use disinfectants containing quaternary
ammonium salts or chlorhexidine for skin preparations because
hyaluronan can precipitate in their presence. Do not inject
intravascularly because intravascular injections of 1% sodium
hyaluronate may cause systemic adverse events.
The safety and effectiveness of 1% sodium hyaluronate has not
been established in pregnant women. It is not known if 1% sodium
hyaluronate is excreted in human milk. The safety and effectiveness
of 1% sodium hyaluronate has not been established in lactating
women or in children (21 years of age or younger).
The most common target-knee related treatment-emergent adverse
event (TEAE) was arthralgia. The most common device-related and
injection-related TEAE was injection site joint pain.
For more information, please see accompanying Full Prescribing
Information. A copy may be requested from Teva US Medical
Information at 888-TEVA-USA (888-838-2872), druginfo@tevapharm.com,
or Teva’s Public Relations or Investor Relations contacts.
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 35,000
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
regarding the launch and potential benefits of 1% sodium
hyaluronate 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:
- The uncertainty of the commercial success of 1% sodium
hyaluronate;
- 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 new 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; 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; 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 our Annual Report on Form 10-K
for the year ended December 31, 2018, including the sections
thereof captioned "Risk Factors." 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.
1 Euflexxa is a registered trademark of Ferring BV
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