Teva launches generic version of Tracleer tablets in the United States

June 20, 2019 Off By BusinessWire

JERUSALEM–(BUSINESS WIRE)–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), [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
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 Ltd
² https://rarediseases.org/rare-diseases/pulmonary-arterial-hypertension/