Teva Enhances ADHD Product Line with Generic INTUNIV® in the United States
02 Juin 2015 - 4:00PM
Business Wire
Teva adds the first nonstimulant therapy to
existing line of seven ADHD products
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced
the launch of the generic equivalent to INTUNIV® (guanfacine) 1 mg,
2 mg, 3 mg, and 4 mg, in the United States. Guanfacine
extended-release tablets are a nonstimulant medication for the
treatment of attention deficit hyperactivity disorder (ADHD) that
can be used alone, or as an add-on to stimulant medications.
ADHD is the most common neurobehavioral disorder diagnosed in
children in the United States. ADHD affects 1 in 10 U.S. children
and half of these children are diagnosed by the age of six.
“Guanfacine extended-release tablets join Teva’s current generic
line of seven ADHD products,” commented Brendan O’Grady, President
and CEO, North America Generic Medicines. “We recognize the need to
make affordable generic treatment options available to patients
with ADHD.”
INTUNIV® (guanfacine) 1 mg, 2 mg, 3 mg, and 4 mg, had total
market sales of approximately $804 million in the United States,
according to IMS data as of March 2015.
About Guanfacine Extended-Release
Tablets
Guanfacine extended-release tablets are indicated for the
treatment of attention deficit hyperactivity disorder (ADHD) as
monotherapy and as adjunctive therapy to stimulant medications.
Safety and efficacy of guanfacine extended-release tablets in
pediatric patients less than 6 years of age have not been
established.
Important Safety Information
Guanfacine extended-release tablets are contraindicated in
patients with a history of a hypersensitivity reaction to
guanfacine extended-release tablets or its inactive ingredients, or
other products containing guanfacine. Rash and pruritus have been
reported.
Treatment with guanfacine extended-release tablets can cause
dose-dependent decreases in blood pressure and heart rate.
Orthostatic hypotension and syncope have been reported. Somnolence
and sedation were commonly reported adverse reactions in clinical
studies. The sympatholytic action of guanfacine extended-release
tablets may worsen sinus node dysfunction and atrioventricular (AV)
block, especially in patients taking other sympatholytic drugs.
Most common adverse reactions (≥ 5% and at least twice placebo
rate) in clinical trials: somnolence, fatigue, hypotension, nausea,
lethargy, abdominal pain, insomnia, dizziness, dry mouth,
irritability, vomiting, and bradycardia.
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 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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version on businesswire.com: http://www.businesswire.com/news/home/20150602006231/en/
Teva Pharmaceutical Industries Ltd.IR:Kevin C. Mannix,
215-591-8912United StatesorRan Meir, 215-591-3033United
StatesorTomer Amitai, 972 (3) 926-7656IsraelorPR:Iris
Beck Codner, 972 (3) 926-7687IsraelorDenise Bradley,
215-591-8974United States
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