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Teva Announces Launch of a Generic Version of Letairis® (ambrisentan) Tablets in the United States

May 1, 2019 Off By BusinessWire

JERUSALEM–(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), [email protected],
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.