JERUSALEM--(BUSINESS WIRE)--Oct. 12, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced the
exclusive launch of the generic equivalent to Avodart®
(dutasteride) capsules, 0.5 mg, in the United States. Dutasteride is a 5
alpha-reductase enzyme inhibitor and works by lowering production of a
hormone called dihydrotestosterone (DHT). Dutasteride capsules are used
to treat the symptoms of benign prostatic hyperplasia (BPH) in men with
an enlarged prostate.
Teva was first to file and expects to be exclusive for several weeks.
Avodart® (dutasteride) capsules, marketed by GlaxoSmithKline,
had annual sales of approximately $467 million in the United States,
according to IMS data as of July 2015.
About Dutasteride Capsules
Dutasteride
capsules are indicated for the treatment of symptomatic BPH in men with
an enlarged prostate to: improve symptoms, reduce the risk of acute
urinary retention and reduce the risk of the need for BPH-related
surgery. Dutasteride capsules in combination with the alpha adrenergic
antagonist, tamsulosin, are indicated for the treatment of symptomatic
BPH in men with an enlarged prostate. Dutasteride capsules are not
approved for the prevention of prostate cancer.
Important Safety Information
Dutasteride
capsules are for use for men only. Dutasteride capsules are
contraindicated for use in: pregnancy and women of childbearing
potential; pediatric patients; and patients with previously
demonstrated, clinically significant hypersensitivity (e.g., serious
skin reactions, angioedema) to dutasteride or other 5 alpha-reductase
inhibitors.
Dutasteride reduces serum prostate-specific antigen (PSA) concentration
by approximately 50%. However, any confirmed increase in PSA while on
dutasteride may signal the presence of prostate cancer and should be
evaluated, even if those values are still within the normal range for
untreated men. Dutasteride may increase the risk of high-grade prostate
cancer. Prior to initiating treatment with dutasteride, consideration
should be given to other urological conditions that may cause similar
symptoms. Women who are pregnant or could become pregnant should not
handle dutasteride capsules due to potential risk to a male fetus.
Patients should not donate blood until 6 months after their last dose of
dutasteride.
The most common adverse reactions, reported in ≥ 1% of subjects treated
with dutasteride and more commonly than in subjects treated with
placebo, are impotence, decreased libido, ejaculation disorders, and
breast disorders
For more information, please see the 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 to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 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 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially Copaxone® (including
competition from orally-administered alternatives, as well as from
potential purported generic equivalents) and our ability to migrate
users to our 40 mg/mL version; the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; our ability to
achieve expected results from the research and development efforts
invested in our pipeline of specialty and other products; our ability to
reduce operating expenses to the extent and during the timeframe
intended by our cost reduction program; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the extent
to which any manufacturing or quality control problems damage our
reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and Europe of our patent
settlement agreements; our exposure to currency fluctuations and
restrictions as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the effects of
reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with internal
or third-party information technology systems that adversely affect our
complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
competition for our specialty pharmaceutical businesses from companies
with greater resources and capabilities; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; potentially significant increases in tax
liabilities; 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; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2014 and in our other filings with the U.S. Securities and Exchange
Commission. 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 statement, whether as a result of new information,
future events or otherwise.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
or
Nancy Leone, 215-284-0213