Company offers wraparound services to improve
patient access to sildenafil tablets
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the exclusive launch of its generic Viagra®1 (sildenafil
citrate) tablets in the U.S.
Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor
indicated for the treatment of erectile dysfunction (ED).
“The launch of Teva’s sildenafil tablets brings an affordable
generic treatment option to the estimated 18 million men in the
U.S. who are diagnosed with erectile dysfunction,” said Brendan
O’Grady, Executive Vice President, North America Commercial at
Teva. “Our team has made it a priority to ensure that patients are
able to access this medicine—through both traditional and more
innovative channels.”
Teva is also offering wraparound services to support patients,
such as a sildenafil tablets savings card with which people who
meet certain requirements are eligible to participate in the
program and may pay as little as $0 out-of-pocket with a maximum
benefit of up to $100 per fill, for up to six sildenafil tablets
prescriptions.
TevaSildenafil.com includes information on how patients may
order their medicine online and have it shipped directly to them as
well as how to obtain it through traditional retail channels.
Additionally, patients can call Teva customer service, 1-888 TEVA
USA (888 838-2872) for assistance in finding a local pharmacy that
carries Teva’s sildenafil tablets and that can fill their
prescription.
With nearly 600 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 seven
generic prescriptions dispensed in the U.S. is filled with a Teva
generic product.
Viagra® had annual sales of approximately $1.4 billion in the
U.S., according to IMS data as of August 2017.
About Sildenafil Tablets
Sildenafil tablets are indicated for the treatment of erectile
dysfunction.
Important Safety Information
Sildenafil tablets were shown to potentiate the hypotensive
effects of nitrates, and their administration to patients who are
using nitric oxide donors such as organic nitrates or organic
nitrites in any form either regularly and/or intermittently is
contraindicated. Sildenafil tablets are contraindicated in patients
with a known hypersensitivity to sildenafil, as contained in
sildenafil tablets and REVATIO®2, or any component of the tablet.
Do not use sildenafil tablets in patients who are using a GC
stimulator, such as riociguat. Sildenafil tablets may potentiate
the hypotensive effects of GC stimulators.
Due to the potential for cardiac risk, sildenafil tablets should
not be generally used in men for whom sexual activity is
inadvisable because of their underlying cardiovascular status.
Prolonged erection greater than 4 hours and priapism have been
reported infrequently. Sildenafil tablets should be used with
caution in patients with anatomical deformation of the penis (such
as angulation, cavernosal fibrosis or Peyronie’s disease), or in
patients who have conditions which may predispose them to priapism
(such as sickle cell anemia, multiple myeloma, or leukemia).
Other possible serious adverse reactions include: a sudden loss
of vision in one or both eyes which may be a sign of non-arteritic
anterior ischemic optic neuropathy (NAION), a rare condition and a
cause of decreased vision including permanent loss of vision; and a
sudden decrease or loss of hearing, which may be accompanied by
tinnitus and dizziness.
Concomitant use of sildenafil tablets and alpha-blockers or
anti-hypertensives may lead to hypotension. The concomitant
administration of sildenafil tablets and the protease inhibitor
ritonavir substantially increases serum concentrations of
sildenafil. There have been postmarketing reports of bleeding
events in patients who have taken sildenafil.
The most common adverse reactions reported in clinical trials
(≥2%) were headache, flushing, dyspepsia, abnormal vision, nasal
congestion, back pain, myalgia, nausea, dizziness, and rash.
For more information, please see accompanying Full Prescribing
Information.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200
million patients in 60 markets every day. Headquartered in Israel,
Teva is the world’s largest generic medicines producer, leveraging
its portfolio of more than 1,800 molecules to produce a wide range
of generic products in nearly every therapeutic area. In specialty
medicines, Teva has the world-leading innovative treatment for
multiple sclerosis as well as late-stage development programs for
other disorders of the central nervous system, including movement
disorders, migraine, pain and neurodegenerative conditions, as well
as a broad portfolio of respiratory products. Teva is leveraging
its generics and specialty capabilities in order to seek new ways
of addressing unmet patient needs by combining drug development
with devices, services and technologies. Teva's net revenues in
2016 were $21.9 billion. For more information, visit
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 Teva's generic
version of Viagra®, 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:
- commercial success of Teva's generic
version of sildenafil;
- our generics medicines business,
including: that we are substantially more dependent on this
business, with its significant attendant risks, following our
acquisition of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”); our ability to realize the
anticipated benefits of the acquisition (and any delay in realizing
those benefits) or difficulties in integrating Actavis Generics;
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
generic products, both from competing products and as a result of
increased governmental pricing pressures; and our ability to take
advantage of high-value biosimilar opportunities;
- our business and operations in general,
including: uncertainties relating to the potential benefits and
success of our new organizational structure and recent senior
management changes; the potential success and our ability to
effectively execute a restructuring plan; our ability to develop
and commercialize additional pharmaceutical products; 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; the restructuring of our
manufacturing network, including potential related labor unrest;
the impact of continuing consolidation of our distributors and
customers; variations in patent laws that may adversely affect our
ability to manufacture our products; adverse effects of political
or economic instability, major hostilities or terrorism on our
significant worldwide operations; and our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; and
- 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; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; 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.
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”)
and in our other filings with the U.S. Securities and Exchange
Commission (the “SEC”). 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, future events or otherwise. You are cautioned not to
rely on these forward-looking statements. You are advised to
consult any additional disclosures we make in our reports to
the SEC on Form 6-K, as well as the cautionary discussion of
risks and uncertainties under “Risk Factors” in our Annual Report.
These are factors that we believe could cause our actual results to
differ materially from expected results. Other factors besides
those listed could also materially and adversely affect us. This
discussion is provided as permitted by the Private Securities
Litigation Reform Act of 1995.
###
1 Viagra® is a registered trademark of Pfizer Inc.2 Revatio® is
a registered trademark of Pfizer Inc.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171211005614/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7208orUnited
StatesDenise Bradley, 215-591-8974
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