JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the launch of a generic version of VESIcare ®1
(solifenacin succinate) Tablets, 5 mg and 10 mg, in the U.S.
Solifenacin Succinate Tablets are a muscarinic antagonist indicated for
the treatment of overactive bladder with symptoms of urge urinary
incontinence, urgency, and urinary frequency. Overactive bladder (OAB)
is most often characterized by a strong sudden urge to urinate that is
difficult to control.
“About 33 million Americans have overactive bladder.2 We’re
proud to offer another treatment option for this common condition,” 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.
VESIcare® Tablets have annual sales of more than $955 million
in the U.S., according to IQVIA data as of February 2019.
About Solifenacin Succinate Tablets
Solifenacin Succinate Tablets are a muscarinic antagonist indicated for
the treatment of overactive bladder with symptoms of urge urinary
incontinence, urgency, and urinary frequency.
IMPORTANT SAFETY INFORMATION
Solifenacin Succinate Tablets are contraindicated in patients with
urinary retention, gastric retention, uncontrolled narrow-angle
glaucoma, and in patients who have demonstrated hypersensitivity to the
drug.
Angioedema of the face, lips, tongue, and/or larynx have been reported
with solifenacin. Angioedema associated with upper airway swelling may
be life threatening. Anaphylactic reactions have been reported rarely in
patients treated with solifenacin succinate. Solifenacin Succinate
Tablets should not be used in patients with a known or suspected
hypersensitivity to solifenacin succinate.
Solifenacin succinate should be administered with caution to patients
with clinically significant bladder outflow obstruction because of the
risk of urinary retention. Solifenacin succinate should be used with
caution in patients with decreased gastrointestinal motility.
Solifenacin succinate is associated with anticholinergic central nervous
system (CNS) effects. A variety of CNS anticholinergic effects have been
reported, including headache, confusion, hallucinations and somnolence.
Solifenacin succinate should be used with caution in patients being
treated for narrow-angle glaucoma.
Solifenacin succinate should be used with caution in patients with
hepatic or renal impairment. Doses of solifenacin succinate greater than
5 mg are not recommended in patients with moderate hepatic impairment or
severe renal impairment. Solifenacin succinate is not recommended for
patients with severe hepatic impairment. Solifenacin succinate should be
used with caution in patients with a known history of QT prolongation or
patients who are taking medications known to prolong the QT interval.
In clinical trials, the most common adverse reactions (> 4% and >
placebo) were dry mouth, and constipation at both 5 mg and 10 mg doses;
and urinary tract infection, and blurred vision at the 10 mg dose.
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), 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 VESIcare®,
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 VESIcare
®, including due to a potential launch of an authorized
generic version;
- The uncertainty of the commercial success of our generic version of VESIcare
-
- 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 ability to successfully compete in the marketplace, including:
-
- 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 substantial indebtedness, which may limit our ability to incur
-
- 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 ;
- our business and operations in general, including: failure to
-
- 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;
- compliance, regulatory and litigation matters, including: costs and
-
- 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;
- other financial and economic risks, including: our exposure to
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 VESIcare® is a registered trademark of Astellas
Pharma, Inc.
2 Urology Care Foundation: https://www.urologyhealth.org/urologic-conditions/overactive-bladder-(oab)
Contacts
IR
United States
Kevin C. Mannix
(215)
591-8912
Israel
Ran Meir
972 (3) 926-7516
PR
United
States
Kelley Dougherty
(973) 658-0237
Israel
Yonatan
Beker
972 (54) 888 5898