Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of a generic version of Elidel®1
(pimecrolimus) Cream, 1% in the U.S.
Pimecrolimus Cream, 1% is a topical prescription medicine to be
used as second-line therapy for the short-term and non-continuous
chronic treatment of mild to moderate eczema (atopic dermatitis) in
non-immunocompromised adults and children 2 years of age and older
who have failed to respond adequately to other topical prescription
treatments, or when those treatments are not advisable.
Brendan O’Grady, EVP and Head of North America Commercial at
Teva said, “We’re proud to offer another affordable treatment
option. This launch represents an important addition to our
generics portfolio and underscores our commitment to ensuring that
patients have more treatment options.”
With over 550 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
product.
Elidel® Cream, 1% had annual sales of approximately $218.4
million in the US, according to IQVIA data as of October 2018.
About Pimecrolimus Cream, 1%
Pimecrolimus Cream, 1% is indicated as second-line therapy for
the short-term and non-continuous chronic treatment of mild to
moderate atopic dermatitis in non-immunocompromised adults and
children 2 years of age and older, who have failed to respond
adequately to other topical prescription treatments, or when those
treatments are not advisable.
IMPORTANT SAFETY INFORMATION
WARNING: Long-term Safety of Topical Calcineurin Inhibitors
Has Not Been Established. Although a causal relationship has
not been established, rare cases of malignancy (e.g., skin and
lymphoma) have been reported in patients treated with topical
calcineurin inhibitors, including Pimecrolimus Cream, 1%.
Continuous long-term use of topical calcineurin inhibitors,
including Pimecrolimus Cream, 1%, in any age group should be
avoided, and application limited to areas of involvement with
atopic dermatitis. Pimecrolimus Cream, 1% is not indicated
for use in children less than 2 years of age.
Pimecrolimus Cream, 1% is contraindicated in individuals with a
history of hypersensitivity to pimecrolimus or any of the
components of the cream. Pimecrolimus Cream, 1% should not be used
in immunocompromised adults and children, including patients on
systemic immunosuppressive medications. The use of pimecrolimus
cream, 1% should be avoided on malignant or pre-malignant skin
conditions. Malignant or pre-malignant skin conditions, such as
cutaneous T-cell lymphoma (CTCL), can present as dermatitis.
Pimecrolimus Cream, 1% should not be used in patients with
Netherton’s Syndrome or other skin diseases where there is the
potential for increased systemic absorption of pimecrolimus. The
safety of Pimecrolimus Cream, 1% has not been established in
patients with generalized erythroderma.
Before commencing treatment with Pimecrolimus Cream, 1%,
bacterial or viral infections at treatment sites should be
resolved. The use of Pimecrolimus Cream, 1% may cause local
symptoms such as skin burning (burning sensation, stinging,
soreness) or pruritus. During the course of treatment, it is
prudent for patients to minimize or avoid natural or artificial
sunlight exposure, even while Pimecrolimus Cream, 1% is not on the
skin. The potential effects of Pimecrolimus Cream, 1% on skin
response to ultraviolet damage are not known.
In clinical trials, cases of lymphadenopathy were reported while
using Pimecrolimus Cream, 1%. The safety and efficacy of
Pimecrolimus Cream, 1% in immunocompromised patients have not been
studied. In clinical trials, the most commonly reported adverse
reactions (greater than or equal to 1%) were application site
burning, headache, nasopharyngitis, cough, influenza, pyrexia and
viral infection.
For more information, please see accompanying Full Prescribing
Information, including Boxed Warning. A copy may be requested from
Teva US Medical Information at 888-4-TEVA-USA (888-838-2872) or
druginfo@tevapharm.com, or Teva’s Public Relations or Investor
Relations contacts.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
global leader in generic medicines, with innovative treatments in
select areas, including CNS, pain and respiratory. We deliver
high-quality generic products and medicines in nearly every
therapeutic area to address unmet patient needs. We have an
established presence in generics, specialty, OTC and API, building
on more than a century-old legacy, with a fully integrated R&D
function, strong operational base and global infrastructure and
scale. We strive to act in a socially and environmentally
responsible way. Headquartered in Israel, with production and
research facilities around the globe, we employ 45,000
professionals, committed to improving the lives of millions of
patients. Learn more at 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 Teva's generic version of Elidel®2, 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:
- The uncertainty of the commercial
success of our generic version of pimecrolimus cream.
- our ability to successfully compete in
the marketplace, including: that we are substantially dependent on
our generic products; competition for our specialty products,
especially COPAXONE®, our leading medicine, which faces competition
from existing and potential additional generic versions and
orally-administered alternatives; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; 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 products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our substantially increased
indebtedness and significantly decreased cash on hand, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, and may result in
a further downgrade of our credit ratings; and our inability to
raise debt or borrow funds in amounts or on terms that are
favorable to us;
- our business and operations in general,
including: failure to effectively execute the restructuring plan
announced in December 2017; uncertainties related to, and failure
to achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the ongoing review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; 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;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; and our prospects and opportunities for growth if we
sell assets;
- 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; governmental investigations
into sales and marketing practices; potential liability for patent
infringement; 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;
- other financial and economic risks,
including: our exposure to currency fluctuations and restrictions
as well as credit risks; potential impairments of our intangible
assets; potential significant increases in tax liabilities; and 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;
and other factors discussed in our Annual Report on Form 10-K
for the year ended December 31, 2017, 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 ELIDEL® is a registered trademark of Meda Pharma S.A.R.L. used
under license © 2017 Valeant Pharmaceuticals North America LLC.2
ELIDEL® is a registered trademark of Meda Pharma S.A.R.L. used
under license © 2017 Valeant Pharmaceuticals North America LLC.
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IR ContactsUnited StatesKevin C. Mannix(215)
591-8912
IsraelRan Meir(215) 591-3033
PR ContactsUnited StatesElizabeth DeLuca(267)
468-4329
IsraelYonatan Beker972 (54) 888 5898
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