Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of generic Axiron®1 (testosterone) topical
solution CIII, 30 mg/1.5 mL, in the U.S.
Testosterone topical solution CIII is a prescription medicine
used to treat adult males who have low or no testosterone due to
certain medical conditions. It is supplied in a metered dose pump
with an underarm applicator.
“We are pleased with the result in the district court, which has
helped Teva add yet another product to our industry-leading generic
portfolio, providing savings to our customers and to patients,”
said Andy Boyer, Teva’s President and CEO, Global Generic
Medicines, North America. “Teva continues to lead the industry in
bringing new generic products to the U.S. market.”
Teva is committed to strengthening its generics business through
continued investment in complex, high-quality products. With nearly
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.
Axiron® had annual sales of approximately $247 million in the
U.S., according to IMS data as of May 2017.
About Testosterone Topical Solution CIII
Testosterone topical solution is indicated for replacement
therapy in 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 (FSH, 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 topical
solution in men with “age-related hypogonadism” (also referred to
as “late-onset hypogonadism”) have not been established. Safety and
efficacy of testosterone topical solution in males less than 18
years old have not been established.
Due to lack of controlled studies in women and potential
virilizing effects, testosterone topical solution 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 topical testosterone products. Children should
avoid contact with unwashed or unclothed application sites in men
using testosterone topical solution. Healthcare providers should
advise patients to strictly adhere to recommended instructions for
use.
Testosterone topical solution is contraindicated in men with
carcinoma of the breast or known or suspected carcinoma of the
prostate. Testosterone topical solution is contraindicated in women
who are, or who may become pregnant, or who are breastfeeding.
Testosterone topical solution may cause fetal harm when
administered to a pregnant woman. Testosterone topical solution may
cause serious adverse reactions in nursing infants. If a pregnant
woman is exposed to testosterone topical solution, 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.
In clinical trials, the most common adverse reactions (incidence
greater than 4%) were skin application site reactions, increased
hematocrit, headache, diarrhea, vomiting, and increased serum
prostate specific antigen (PSA).
For more information, please see accompanying Full Prescribing
Information, including Boxed Warning.
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 Axiron®, 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 generic
version of testosterone topical solution;
- 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: uncertainties relating to our recent senior management
changes; 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; variations in
patent laws that may adversely affect our ability to manufacture
our products; adverse effects of political or economic instability,
major hostilities or terrorism on our significant worldwide
operations; and our ability to successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; and
- 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”) and in our other filings with
the U.S. Securities and Exchange Commission (the “SEC”).
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 rely on these forward-looking statements.
You are advised to consult any additional disclosures we make in
our reports to the SEC on Form 6-K, as well as the cautionary
discussion of risks and uncertainties under “Risk Factors” in our
Annual Report. These are factors that we believe could cause our
actual results to differ materially from expected results. Other
factors besides those listed could also materially and adversely
affect us. This discussion is provided as permitted by the Private
Securities Litigation Reform Act of 1995.
1 AXIRON is a registered trademark of Eli Lilly and Company.
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version on businesswire.com: http://www.businesswire.com/news/home/20170818005480/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) 926-7687orUnited
StatesDenise Bradley, 215-591-8974orNancy Leone,
215-284-0213
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