Teva Announces Launch of a Generic Version of Ranexa® (ranolazine) Extended-Release Tablets in the United States
May 28, 2019JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of a generic version of Ranexa®1
(ranolazine) Extended-Release Tablets, 500 mg and 1000 mg, in the U.S.
Ranolazine Extended-Release Tablets are indicated for the treatment of
chronic angina.
“We’re pleased to add to our portfolio of generic medicines that offer
another treatment option for people living with chronic conditions like
angina,” said Brendan O’Grady, EVP and Head of North America Commercial.
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.
Ranolazine Extended-Release Tablets has annual sales of nearly $938
million in the U.S., according to IQVIA data as of February 2019.
About Ranolazine Extended-Release Tablets
Ranolazine Extended-Release Tablets are indicated for the treatment of
chronic angina. Ranolazine Extended-Release Tablets may be used with
beta-blockers, nitrates, calcium channel blockers, anti-platelet
therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin
receptor blockers.
IMPORTANT SAFETY INFORMATION
Ranolazine Extended-Release Tablets are contraindicated in patients
taking strong inhibitors of CYP3A; patients taking inducers of CYP3A;
and patients with liver cirrhosis.
Ranolazine blocks IKr and prolongs the QTc interval in a
dose-related manner. Clinical experience in an acute coronary syndrome
population did not show an increased risk of proarrhythmia or sudden
death. However, there is little experience with high doses (greater than
1,000 mg twice daily) or exposure, other QT-prolonging drugs, potassium
channel variants resulting in a long QT interval, in patients with a
family history of (or congenital) long QT syndrome, or in patients with
known acquired QT interval prolongation. Acute renal failure has been
observed in some patients with severe renal impairment (creatinine
clearance less than 30 mL/min) while taking Ranolazine Extended-Release
Tablets.
In controlled clinical trials of angina patients, the most frequently
reported treatment-emergent adverse reactions (greater than 4% and more
common on Ranolazine Extended-Release Tablets than on placebo) were
dizziness, headache, constipation, and nausea. Dizziness may be
dose-related.
For more information, please see accompanying Full
Prescribing Information. 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
Ranexa®, 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
Ranexa®, -
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 Ranexa® is a registered trademark of Gilead
Sciences, Inc.
Contacts
IR Contacts
United States
Kevin C. Mannix
(215)
591-8912
Israel
Ran Meir
972 (3) 926-7516
PR Contacts
United States
Kelley Dougherty
(973)
658-0237
Israel
Yonatan Beker
972 (54) 888 5898