JERUSALEM--(BUSINESS WIRE)--Jul. 28, 2017--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170728005111/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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or
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or
Israel
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or
PR Contacts:
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Iris
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or
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