Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the launch of a generic version of AndroGel ®i
(testosterone gel) 1.62% CIII in the U.S.
Testosterone Gel 1.62% CIII is indicated for replacement therapy
in adult males for conditions associated with a deficiency or
absence of endogenous testosterone: primary hypogonadism
(congenital or acquired), and hypogonadotropic hypogonadism
(congenital or acquired).
With nearly 500 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 eight
generic prescriptions dispensed in the U.S. is filled with a Teva
generic product.
Testosterone Gel 1.62% CIII has annual sales of more than $911
million in the U.S., according to IQVIA data as of February
2019.
About Testosterone Gel 1.62% CIII
Testosterone gel 1.62% is indicated for replacement therapy in
adult males for conditions associated with a deficiency or absence
of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular
failure due to conditions such as cryptorchidism, bilateral
torsion, orchitis, vanishing testis syndrome, orchiectomy,
Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol
or heavy metals. These men usually have low serum testosterone
concentrations and gonadotropins (follicle-stimulating hormone
[FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired):
gonadotropin or luteinizing hormone-releasing hormone (LHRH)
deficiency or pituitary-hypothalamic injury from tumors, trauma, or
radiation. These men have low testosterone serum concentrations,
but have gonadotropins in the normal or low range.
Limitations of use: Safety and efficacy of testosterone gel
1.62% in men with “age-related hypogonadism” (also referred to as
“late-onset hypogonadism”) have not been established. Safety and
efficacy of testosterone gel 1.62% in males less than 18 years old
have not been established. Topical testosterone products may have
different doses, strengths, or application instructions that may
result in different systemic exposure.
Due to the lack of controlled evaluations in women and potential
virilizing effects, testosterone gel 1.62% is not indicated for use
in women.
IMPORTANT SAFETY INFORMATION
WARNING: Secondary Exposure to Testosterone. Virilization has
been reported in children who were secondarily exposed to
testosterone gel. Children should avoid contact with unwashed or
unclothed application sites in men using testosterone gel.
Healthcare providers should advise patients to strictly adhere to
recommended instructions for use.
Testosterone gel 1.62% is contraindicated in men with carcinoma
of the breast or known or suspected carcinoma of the prostate.
Testosterone gel 1.62% is contraindicated in women who are or may
become pregnant, or who are breastfeeding. Testosterone gel 1.62%
may cause fetal harm when administered to a pregnant woman.
Testosterone gel 1.62% may cause serious adverse reactions in
nursing infants. Exposure of a fetus or nursing infant to androgens
may result in varying degrees of virilization. Pregnant women or
those who may become pregnant need to be aware of the potential for
transfer of testosterone from men treated with testosterone gel
1.62%. If a pregnant woman is exposed to testosterone gel 1.62%,
she should be apprised of the potential hazard to the fetus.
Other serious risks include: worsening of benign prostatic
hyperplasia, potential risk of prostate cancer, polycythemia,
venous thromboembolism, cardiovascular risk, potential for adverse
effects on spermatogenesis, hepatic adverse effects, edema,
gynecomastia, sleep apnea, changes in serum lipid profile,
hypercalcemia, and decreased thyroxine-binding globulin.
Testosterone has been subject to abuse, typically at doses
higher than recommended for the approved indication and in
combination with other anabolic androgenic steroids. Anabolic
androgenic steroid abuse can lead to serious cardiovascular and
psychiatric adverse reactions.
Alcohol based products, including testosterone gel 1.62%, are
flammable; therefore, patients should be advised to avoid fire,
flame or smoking until the testosterone gel 1.62% has dried.
In clinical trials, the most common adverse reaction (incidence
greater than or equal to 5%) was an increase in prostate specific
antigen (PSA).
For more information, please see accompanying Full Prescribing
Information, including Boxed Warning. A copy may be requested from
Teva U.S. Medical Information at 888-TEVA-USA (888-838-2872),
druginfo@tevapharm.com, or Teva’s Public Relations or Investor
Relations contacts.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 35,000
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. 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 the launch and potential benefits of the generic version
of AndroGel ®, 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 AndroGel ®,
- 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; the uncertainty of commercial
success of AJOVY® or AUSTEDO®; 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 substantial indebtedness, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, 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 our 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 selling 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, 2018, including the sections
thereof captioned "Risk Factors." 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.
i AndroGel ® is a registered trademark of AbbVie, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20190411005514/en/
IR ContactsUnited StatesKevin C. Mannix(215)
591-8912
IsraelRan Meir972 (3) 926-7516
PR ContactsUnited StatesKelley Dougherty(973)
658-0237
IsraelYonatan Beker972 (54) 888 5898
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