Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of generic version of Syprine®1 (trientine
hydrochloride) capsules, 250 mg, in the U.S.
Trientine hydrochloride is used in the treatment of patients
with Wilson’s disease who are intolerant of penicillamine.
Wilson’s disease is a genetic disease that prevents the body
from removing extra copper. The body needs a small amount of copper
from food to stay healthy, but over time, high copper levels can
cause life-threatening organ damage. Wilson’s disease is a rare
disorder that affects approximately 1 in 30,000 individuals.2
“The launch of trientine hydrochloride capsules illustrates
Teva’s commitment to serving patient populations in need—whether
it’s a medicine that could be taken by millions of individuals, or
one focused on a rare condition disorder like Wilson’s disease,”
said Brendan O’Grady, Executive Vice President and Head of North
America Commercial at Teva.
“Trientine hydrochloride capsules were included on the FDA’s
recent publication of a list of off-patent, off-exclusivity branded
drugs without approved generics,” said Hafrun Fridriksdottir,
Executive Vice President, Global R&D, Teva. “Teva filed our
ANDA more than two years ago and we are pleased that the FDA has
now approved our applications and we are able to offer a lower-cost
generic alternative to patients. We look forward to working closely
with the FDA on their review of our many other generic
applications.”
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.
Trientine hydrochloride had annual sales of approximately $155
million in the U.S. according to IMS data as of November 2017.
About Trientine Hydrochloride Capsules
Trientine hydrochloride capsules are indicated in the treatment
of patients with Wilson's disease who are intolerant of
penicillamine. Clinical experience with trientine hydrochloride is
limited and alternate dosing regimens have not been
well-characterized; all endpoints in determining an individual
patient's dose have not been well defined. Trientine hydrochloride
and penicillamine cannot be considered interchangeable. Trientine
hydrochloride should be used when continued treatment with
penicillamine is no longer possible because of intolerable or life
endangering side effects.
Unlike penicillamine, trientine hydrochloride is not recommended
in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl
moiety renders it incapable of binding cystine and, therefore, it
is of no use in cystinuria. In 15 patients with rheumatoid
arthritis, trientine hydrochloride was reported not to be effective
in improving any clinical or biochemical parameter after 12 weeks
of treatment. Trientine hydrochloride is not indicated for
treatment of biliary cirrhosis.
Important Safety Information
Trientine hydrochloride capsules are contraindicated in patients
with hypersensitivity to this product. Patients should be observed
closely for signs of possible hypersensitivity. There have been
reports of asthma, bronchitis and dermatitis occurring after
prolonged environmental exposure with other uses of trientine
hydrochloride.
Patient experience with trientine hydrochloride is limited.
Patients receiving trientine hydrochloride capsules should remain
under regular medical supervision throughout the period of drug
administration. Patients (especially women) should be closely
monitored for evidence of iron deficiency anemia. Trientine
hydrochloride should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
The following adverse reactions have been reported in a clinical
study in patients with Wilson's disease who were on therapy with
trientine hydrochloride: iron deficiency, systemic lupus
erythematosus. In addition, the following adverse reactions have
been reported in marketed use: dystonia, muscular spasm, myasthenia
gravis. The following adverse reactions have been reported in a
clinical study for another use of trientine hydrochloride capsules:
heartburn; epigastric pain and tenderness; thickening, fissuring
and flaking of the skin; hypochromic microcytic anemia; acute
gastritis; aphthoid ulcers; abdominal pain; melena; anorexia;
malaise; cramps; muscle pain; weakness; rhabdomyolysis.
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 millions of patients
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 a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2017 were $22.4 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 Syprine®, 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 trientine hydrochloride, including due to a potential
launch of an Authorized Generic version;
- 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 Syprine® is a registered trademark of Valeant Pharmaceuticals
North America LLC.
2
https://www.niddk.nih.gov/health-information/liver-disease/wilson-disease
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version on businesswire.com: http://www.businesswire.com/news/home/20180209005252/en/
Teva Pharmaceutical Industries Ltd.IR:United
StatesKevin C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7208orUnited StatesElizabeth DeLuca, 267-468-4329
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