Teva Announces Launch of Generic Epiduo® in the United States
28 Juillet 2017 - 2:00PM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of generic Epiduo®1 (adapalene and benzoyl
peroxide) gel, 0.1%/2.5% in the U.S.
Adapalene and benzoyl peroxide gel 0.1%/2.5% is a combination of
adapalene, a retinoid, and benzoyl peroxide, and is indicated for
the topical treatment of acne vulgaris in patients 9 years of age
and older.
“I am very pleased that Teva is introducing another first
generic product, bringing value to our patients and savings to the
US healthcare system,” said Andy Boyer, President & CEO, Global
Generic Medicines, North America.”
Teva was the first company to file a generic application for
Epiduo and is expected to benefit from 180-days of generic product
exclusivity. This launch marks the most recent addition to Teva’s
portfolio of over 40 dermatology products.
“This is an extremely important development for Teva in our
desire to make a meaningful difference to the millions of patients
who suffer from acne in the U.S.,” said Hafrun Fridriksdottir,
Ph.D., EVP, President of Global Generics R&D.
With close to 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 six
generic prescriptions dispensed in the U.S. is filled with a Teva
product.
Adapalene and benzoyl peroxide gel 0.1%/2.5% had annual sales of
approximately $251 million in the U.S. according to IMS data as of
March 2017.
About Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%
Adapalene and benzoyl peroxide gel 0.1%/2.5% is indicated for
the topical treatment of acne vulgaris in patients 9 years of age
and older.
Important Safety Information
Exposure to sunlight, including sunlamps, should be minimized
during use. Patients with high levels of sun exposure and those
with inherent sensitivity to sun should exercise particular
caution. Use of sunscreen products and protective apparel are
recommended when exposure cannot be avoided. Erythema, scaling,
dryness, and stinging/burning may be experienced with use. These
are most likely to occur during the first four weeks of treatment,
are mostly mild to moderate in intensity, and usually lessen with
continued use of the medication. Irritant and allergic contact
dermatitis may occur. The product should not be applied to cuts,
abrasions, eczematous or sunburned skin. Avoid concomitant use of
other potentially irritating topical products. In clinical trials,
the most commonly reported adverse events (greater than or equal to
1%) were dry skin, contact dermatitis, application site burning,
application site irritation and skin irritation.
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 100 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 Epiduo®, 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 adapalene
and benzoyl peroxide gel, 0.1%/2.5%;
- 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: 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,
including those who joined us as part of the Actavis Generics
acquisition; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products;
- 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”),
including in the section captioned "Risk Factors," and in our other
filings with the U.S. Securities and Exchange Commission which
are available at www.sec.gov and www.tevapharm.com. 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 put undue reliance on these forward looking
statements. .
1 Epiduo® is a registered trademark of Galderma Laboratories,
L.P.
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version on businesswire.com: http://www.businesswire.com/news/home/20170728005111/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912orRan 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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