JERUSALEM--(BUSINESS WIRE)--Sep. 25, 2017--
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced the
reintroduction of the generic equivalent to Depo-Provera®1
Contraceptive Injection (medroxyprogesterone acetate injectable
suspension, USP) 150 mg/mL, in the United States. Medroxyprogesterone
acetate injectable suspension is a progestin indicated only for the
prevention of pregnancy.
“This reintroduction brings an additional product to a market that was
previously lacking in options,” said Dr. Hafrun Fridriksdottir,
Executive Vice President, President of Global Generics R&D. “In addition
to its importance to patients who will benefit from access to this
medicine, this reintroduction holds significant importance to Teva and
our generics R&D priorities.”
Teva has been committed to strengthening its generic injectable business
globally, by making continued investment in newer, higher-value generic
injectable 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 seven
generic prescriptions dispensed in the U.S. is filled with a Teva
generic product.
Medroxyprogesterone acetate injectable suspension, USP 150 mg/mL had
annual sales of approximately $211 million in the United States,
according to IMS data as of July 2017.
About Medroxyprogesterone Acetate Injectable Suspension, USP
Medroxyprogesterone acetate injectable suspension is indicated only for
the prevention of pregnancy. The loss of bone mineral density (BMD) in
women of all ages and the impact on peak bone mass in adolescents should
be considered, along with the decrease in BMD that occurs during
pregnancy and/or lactation, in the risk/benefit assessment for women who
use medroxyprogesterone acetate injectable suspension long-term.
Important Safety Information
Women
who use medroxyprogesterone acetate injectable suspension may lose
significant bone mineral density. Bone loss is greater with increasing
duration of use and may not be completely reversible.
Medroxyprogesterone acetate injectable suspension should not be used as
a long-term birth control method (i.e., longer than 2 years) unless
other birth control methods are considered inadequate.
The use of medroxyprogesterone acetate injectable suspension is
contraindicated in the following conditions: known or suspected
pregnancy or as a diagnostic test for pregnancy; active
thrombophlebitis, or current or past history of thromboembolic
disorders, or cerebral vascular disease; known or suspected malignancy
of breast; known hypersensitivity to medroxyprogesterone acetate
injectable suspension or any of its other ingredients; significant liver
disease; or undiagnosed vaginal bleeding.
Studies have shown an increased risk of breast cancer in women using
medroxyprogesterone acetate injectable suspension. Serious thrombotic
events; anaphylaxis and anaphylactoid reaction; injection site
reactions; convulsions; weight gain; and decreased glucose tolerance
have been reported with the use of medroxyprogesterone acetate
injectable suspension.
In clinical trials the most common adverse reactions (incidence > 5%)
were: menstrual irregularities (bleeding or spotting), abdominal
pain/discomfort, dizziness, headache, nervousness, and decreased libido.
Medroxyprogesterone acetate injectable suspension does not protect
against HIV infection (AIDS) and other sexually transmitted diseases.
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 over 60 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
Depo-Provera®, 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 medroxyprogesterone
acetate injectable;
-
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 Depo-Provera® is a registered trademark of Pfizer, Inc.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170925006258/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
Kevin C.
Mannix, United States, 215-591-8912
Ran Meir, United
States, 215-591-3033
Tomer Amitai, Israel, 972 (3)
926-7656
or
PR Contacts:
Iris Beck Codner, Israel,
972 (3) 926-7208
Denise Bradley, United States,
215-591-8974