JERUSALEM–(BUSINESS WIRE)–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 ®,
- The uncertainty of the commercial success of our generic version of
-
- 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 ability to successfully compete in the marketplace, including:
-
- 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 substantial indebtedness, which may limit our ability to incur
-
- 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;
- our business and operations in general, including: failure to
-
- 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;
- compliance, regulatory and litigation matters, including: costs and
-
- 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;
- other financial and economic risks, including: our exposure to
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.
Contacts
IR Contacts
United States
Kevin C. Mannix
(215)
591-8912
Israel
Ran Meir
972 (3) 926-7516
PR Contacts
United States
Kelley Dougherty
(973)
658-0237
Israel
Yonatan Beker
972 (54) 888 5898