JERUSALEM--(BUSINESS WIRE)--Aug. 18, 2017--
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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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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