Teva Announces Launch of a Generic Version of Tracleer® (bosentan) Tablets in the United States
2019年6月20日 - 2:00AM
ビジネスワイヤ(英語)
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of a generic version of Tracleer®1 (bosentan)
tablets, 62.5 mg and 125 mg, in the U.S.
Bosentan Tablets are an endothelin receptor antagonist indicated
for the treatment of pulmonary arterial hypertension (PAH, WHO
Group 1) in adults to improve exercise ability and to decrease
worsening of the condition. PAH is high blood pressure in the blood
vessels of the lungs. Due to the risks of liver damage, and serious
birth defects, Bosentan Tablets are available only through a
restricted distribution program called the Bosentan REMS
Program.
“The launch of Bosentan Tablets in the U.S. is an important
addition to Teva’s generics portfolio,” said Brendan O’Grady, EVP
and Head of North America Commercial. “The exact cause of PAH is
unknown with no known cure.2 We are proud to offer another generic
treatment option to patients living with this chronic
condition.”
With nearly 500 generic medicines available, Teva has the
largest portfolio of FDA-approved generic products on the market
and holds the leading position in first-to-file opportunities, with
over 100 pending first-to-files in the U.S. Currently, one in nine
generic prescriptions dispensed in the U.S. is filled with a Teva
generic product.
About Bosentan Tablets
Bosentan Tablets are indicated for the treatment of pulmonary
arterial hypertension (PAH) (WHO Group 1) in adults to improve
exercise ability and to decrease clinical worsening. Studies
establishing effectiveness included predominantly patients with WHO
Functional Class II-IV symptoms and etiologies of idiopathic or
heritable PAH (60%), PAH associated with connective tissue diseases
(21%), and PAH associated with congenital heart disease with
left-to-right shunts (18%).
Important Safety Information
WARNING: Risks of Hepatotoxicity and Embryo-Fetal
Toxicity. Because of the risks of hepatotoxicity and birth
defects, Bosentan Tablets are available only through a restricted
program called the Bosentan REMS Program. Elevations of liver
aminotransferases (ALT, AST) and liver failure have been reported
with bosentan. Bosentan is likely to cause major birth
defects if used by pregnant females based on animal data.
Therefore, pregnancy must be excluded before the start of
treatment with Bosentan Tablets.
Use of bosentan is contraindicated in females who are or may
become pregnant. To prevent pregnancy, females of reproductive
potential must use two reliable forms of contraception during
treatment and for one month after stopping bosentan.
Coadministration of cyclosporine A and bosentan resulted in
markedly increased plasma concentrations of bosentan. Therefore,
concomitant use of bosentan and cyclosporine A is contraindicated.
An increased risk of liver enzyme elevations was observed in
patients receiving glyburide concomitantly with bosentan. Therefore
coadministration of glyburide and bosentan is contraindicated.
Bosentan is contraindicated in patients who are hypersensitive to
bosentan or any component of the product. Observed reactions
include Drug Reaction with Eosinophilia and Systemic Symptoms
(DRESS), anaphylaxis, rash, and angioedema.
Peripheral edema is a known clinical consequence of PAH and
worsening PAH and is also a known effect of bosentan and other
endothelin receptor antagonists. In PAH clinical trials with
bosentan, combined adverse events of fluid retention or edema were
reported in 1.7% (placebo-corrected) of patients. In addition,
there have been numerous postmarketing reports of fluid retention
in patients with pulmonary hypertension occurring within weeks
after starting bosentan. Patients required intervention with a
diuretic, fluid management, or hospitalization for decompensating
heart failure. Pulmonary edema could be the possibility of
associated pulmonary veno-occlusive disease.
Decreased sperm counts have been observed in patients receiving
bosentan. Preclinical data also suggest that bosentan, similar to
other endothelin receptor antagonists, may have an adverse effect
on spermatogenesis. Treatment with bosentan can cause a
dose-related decrease in hemoglobin and hematocrit. There have been
postmarketing reports of decreases in hemoglobin concentration and
hematocrit that have resulted in anemia requiring transfusion.
In clinical trials, the most common adverse reactions (greater
than or equal to 3% and greater than placebo) were respiratory
tract infection, headache, edema, chest pain, syncope, flushing,
hypotension, sinusitis, arthralgia, abnormal serum
aminotransferases, palpitations, and anemia. Respiratory tract
infection and anemia occurred at a rate greater than or equal to 3%
more than placebo.
For more information, please see accompanying Full Prescribing
Information, including the Boxed Warning. 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 the generic version
of Tracleer® (bosentan) tablets 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 our generic version of Tracleer®;
- 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 Tracleer® is a registered trademark of Actelion
Pharmaceuticals Ltd2
https://rarediseases.org/rare-diseases/pulmonary-arterial-hypertension/
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IR ContactsUnited StatesKevin C. Mannix (215)
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