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JERUSALEM--(BUSINESS WIRE)--Feb. 9, 2018--
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
“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
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 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
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
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
1 Syprine® is a registered trademark of Valeant
Pharmaceuticals North America LLC.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180209005252/en/
Source: Teva Pharmaceutical Industries Ltd.
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