Teva Announces Launch of a Generic Version of Letairis® (ambrisentan) Tablets in the United States
May 01 2019 - 3:01PM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of a generic version of Letairis®1
(ambrisentan) Tablets, 5 mg and 10 mg, in the U.S.
Ambrisentan is an endothelin receptor antagonist indicated for
the treatment of pulmonary arterial hypertension (PAH) (WHO Group
1) to improve exercise ability and delay clinical worsening. In
combination with tadalafil, ambrisentan is indicated to reduce the
risks of disease progression and hospitalization for worsening PAH,
and to improve exercise ability. For all female patients,
ambrisentan tablets are only available through a restricted program
called the Ambrisentan Risk Evaluation & Mitigation Strategy
(REMS) due to the risk of fetal harm.
“The launch of ambrisentan tablets in the U.S. is an important
addition to Teva’s growing generic portfolio of nearly 60
cardiovascular medicines,” said Brendan O’Grady, EVP and Head of
North America Commercial. “Our ability to help treat this disease
is a testament to our commitment to providing affordable, generic
treatment options to people living with chronic, life-long
conditions.”
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 eight
generic prescriptions dispensed in the U.S. is filled with a Teva
generic product.
Letairis® has annual sales of nearly $247 million in the U.S.,
according to IQVIA data as of February 2019.
About Ambrisentan Tablets
Ambrisentan tablets are indicated for the treatment of pulmonary
arterial hypertension (PAH) (WHO Group 1) to improve exercise
ability and delay clinical worsening. In combination with
tadalafil, ambrisentan tablets are indicated to reduce the risks of
disease progression and hospitalization for worsening PAH, and to
improve exercise ability. Studies establishing effectiveness
included predominantly patients with WHO Functional Class II–III
symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH
associated with connective tissue diseases (34%).
IMPORTANT SAFETY INFORMATION
WARNING: Embryo-Fetal Toxicity. Do not administer
ambrisentan to a pregnant female because it may cause fetal harm.
Ambrisentan is very likely to produce serious birth defects if used
by pregnant females, as this effect has been seen consistently when
it is administered to animals. Exclude pregnancy before the
initiation of treatment with ambrisentan. Females of reproductive
potential must use acceptable methods of contraception during
treatment with ambrisentan and for one month after treatment.
Obtain monthly pregnancy tests during treatment and 1 month after
discontinuation of treatment. Because of the risk of
embryo-fetal toxicity, females can only receive ambrisentan through
a restricted program called the Ambrisentan REMS program.
Ambrisentan is contraindicated in patients with Idiopathic
Pulmonary Fibrosis (IPF), including IPF patients with pulmonary
hypertension (WHO Group 3). Peripheral edema is a known class
effect of endothelin receptor antagonists, and is also a clinical
consequence of PAH and worsening PAH. In the placebo-controlled
studies, there was an increased incidence of peripheral edema in
patients treated with doses of 5 or 10 mg ambrisentan compared to
placebo. Peripheral edema/fluid retention is more common with
ambrisentan plus tadalafil than with ambrisentan or tadalafil
alone. Acute pulmonary edema during initiation of therapy with
vasodilating agents, such as ambrisentan, could be the possibility
of pulmonary veno-occlusive disease.
Decreased sperm counts have been observed in human and animal
studies with another endothelin receptor antagonist and in animal
fertility studies with ambrisentan. Ambrisentan may have an adverse
effect on spermatogenesis. Decreases in hemoglobin concentration
and hematocrit have followed administration of other endothelin
receptor antagonists and were observed in clinical studies with
ambrisentan.
In clinical trials, the most common adverse reactions for
ambrisentan (>3% compared to placebo) were peripheral edema,
nasal congestion, sinusitis, and flushing. When used in combination
with tadalafil, most common adverse reactions (>5% compared with
either monotherapy) were peripheral edema, headache, nasal
congestion, cough, anemia, dyspepsia, and bronchitis.
For more information, please see accompanying Full Prescribing
Information, including the Boxed Warning. A copy may be requested
from Teva U.S. 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 Letairis®, 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 Letairis®, including due
to a potential launch of an authorized generic version;
- 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 Letairis® is a registered trademark of Gilead Sciences,
Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190501005918/en/
IR ContactsUnited StatesKevin C. Mannix(215)
591-8912Ran Meir972 (3) 926-7516
PR ContactsUnited StatesKelley Dougherty(973)
658-0237IsraelYonatan Beker972 (54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024