Teva Announces Launch of a Generic Version of VESIcare® (solifenacin succinate) Tablets in the United States

April 22, 2019 Off By BusinessWire

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), [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 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;

- 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 VESIcare^®is a registered trademark of Astellas
Pharma, Inc.
² Urology Care Foundation: https://www.urologyhealth.org/urologic-conditions/overactive-bladder-(oab)