JERUSALEM--(BUSINESS WIRE)--Jul. 24, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the launch of a generic version of Vagifem®1
(estradiol vaginal inserts), 10 mcg in the U.S.
Estradiol vaginal inserts are an estrogen indicated for the treatment of
atrophic vaginitis due to menopause.
Estradiol vaginal inserts add to Teva’s existing portfolio of more than
70 women’s health 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
generic product.
“Our expanding portfolio of oral contraceptives and hormone replacement
therapies gives women a broader choice of products to manage their
health needs cost-effectively,” said Andy Boyer, CEO and President,
Global Generic Medicines, North America at Teva. “With this addition,
patients and healthcare providers who prefer this unique dosage-form now
have another, more affordable option for treatment.”
Estradiol vaginal inserts had annual sales of approximately $379 million
in the U.S. according to IMS data as of May 2017.
About Estradiol Vaginal Inserts
Estradiol vaginal inserts are indicated for the treatment of atrophic
vaginitis due to menopause.
Important Safety Information
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER
and PROBABLE DEMENTIA. There is an increased risk of endometrial
cancer in a woman with a uterus who uses unopposed estrogens. Estrogen-alone
therapy should not be used for the prevention of cardiovascular disease
or dementia. Increased risks of stroke and deep vein thrombosis
(DVT) and increased risk of probable dementia in postmenopausal women 65
years of age and older have been reported with estrogen-alone therapy.
Estrogen plus progestin therapy should not be used for the prevention
of cardiovascular disease or dementia. Increased risks of stroke,
DVT, pulmonary embolism (PE), myocardial infarction (MI), and invasive
breast cancer and an increased risk of probable dementia in
postmenopausal women 65 years of age and older have been reported with
estrogen plus progestin therapy.
Estradiol should not be used in women with any of the following
conditions: undiagnosed abnormal genital bleeding; known, suspected, or
history of breast cancer; known or suspected estrogen-dependent
neoplasia; active DVT, PE, or history of these conditions; active
arterial thromboembolic disease (for example, stroke, and myocardial
infarction), or a history of these conditions; known anaphylactic
reaction or angioedema to estradiol; known liver impairment or disease;
known protein C, protein S, or antithrombin deficiency, or other known
thrombophilic disorders; or known or suspected pregnancy.
Systemic absorption occurs with the use of estradiol. The warnings,
precautions, and adverse reactions associated with the use of systemic
estrogen-alone therapy should be taken into account. Other serious
adverse reactions associated with estrogen administration include:
increased risk of gallbladder disease; severe hypercalcemia in women
with breast cancer and bone metastases; retinal vascular thrombosis;
elevated blood pressure; hypertriglyceridemia; increased thyroid-binding
globulin (TBG) levels; fluid retention; and hypocalcemia. Estrogen
administration may exacerbate: endometriosis, symptoms of angioedema in
women with hereditary angioedema, asthma, diabetes mellitus, epilepsy,
migraine, porphyria, systemic lupus erythematosus, and hepatic
hemangiomas.
A few cases of local abrasion induced by the estradiol applicator have
been reported, especially in women with severely atrophic vaginal
mucosa. In prospective, randomized, placebo-controlled, double-blind
studies the most common adverse reactions (incidence ≥ 5 percent) were
upper respiratory tract infection, headache, abdominal pain, back pain,
genital pruritus, moniliasis, vulvovaginal mycotic infection and
diarrhea.
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
Vagifem®, 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 estradiol vaginal
inserts ®;
-
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 Vagifem® is a registered trademark of Novo Nordisk Health
Care AG.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170724006098/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
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or
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or
Israel
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or
PR Contacts:
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Iris
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or
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Denise
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