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/
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) 926-7208orUnited
StatesDenise Bradley, 215-591-8974
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024