JERUSALEM--(BUSINESS WIRE)--May 5, 2017--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that data suggests that women with relapsing forms of multiple
sclerosis (RMS) who were exposed to COPAXONE® 20 mg/mL daily
during pregnancy are not at higher risk for congenital anomalies
compared to reference rates for abnormal pregnancy outcomes reported in
two large databases representing the general population. These data
appeared as an “Online First” article on the Website of the International
Journal of MS Care (IJMSC) and represent the largest published
analysis of pregnancy pharmacovigilance data for an RMS treatment.
MS is more common among women of childbearing age compared with any
other age group. The average age of diagnosis is 30, and many women go
on to have children after diagnosis. Approximately half of pregnancies
are unintended, which means that women with MS may become pregnant
unexpectedly while taking an MS treatment. None of the MS therapies are
approved for use during pregnancy.
“Physicians now have this data to consider as they consult with their
RMS patients planning a family or already pregnant, to make individual
treatment decisions,” said Patricia K. Coyle, M.D., professor and vice
chair (clinical affairs) of neurology, and the director of the Multiple
Sclerosis Comprehensive Care Center at the Stony Brook University
Medical Center, Stony Brook, New York.
The analysis published in IJMSC compared 5,025 pregnancy cases with
known outcomes from the Glatiramer Acetate (GA) Pharmacovigilance
Database to two other databases of healthy women, the Metropolitan
Atlanta Congenital Defects Program (MACDP)1 and the European
Surveillance of Congenital Anomalies (EUROCAT)2. When
compared to the rate of congenital anomalies from the MACDP database,
the rate for prospective pregnancies among women exposed to COPAXONE®
while pregnant from the GA Pharmacovigilance Database was comparable to
the general U.S. population. Similarly, the comparison between the GA
Pharmacovigilance and EUROCAT data indicated that the rate of congenital
anomalies is very similar to that of the general European population.
“With more than 20 years of data collected on COPAXONE®, we
are able to share this important analysis with physicians to consider
and counsel their patients of child-bearing age,” said Rob Koremans,
M.D., President and CEO, Teva Global Specialty Medicines. “We are
pleased to put forward this data that may help facilitate that
conversation.”
The publication, “Pregnancy Outcomes from the Branded Glatiramer Acetate
Pregnancy Database,” is available online at http://ijmsc.org/doi/abs/10.7224/1537-2073.2016-079.
The International Journal of MS Care is the official
peer-reviewed publication of the Consortium of Multiple Sclerosis
Centers (CMSC).
About COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the
treatment of patients with relapsing forms of multiple sclerosis. The
most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing, rash,
shortness of breath, and chest pain. COPAXONE® is rated as
Pregnancy Category B. There are no adequate and well-controlled studies
in pregnant women. Administration of glatiramer acetate by subcutaneous
injection to pregnant rats and rabbits resulted in no adverse effects on
offspring development. Animal reproduction studies are not always
predictive of human response, therefore COPAXONE® should be
used during pregnancy only if clearly needed. See additional important
information at: www.CopaxonePrescribingInformation.com.
For hardcopy releases, please see enclosed full prescribing information.
The COPAXONE® brand is approved in more than 50 countries
worldwide, including the United States, Russia, Canada, Mexico,
Australia, Israel, and all European countries.
Important Safety Information about COPAXONE®
Patients allergic to glatiramer acetate or mannitol should not take
COPAXONE®. Some patients report a short-term reaction right
after injecting COPAXONE®. This reaction can involve flushing
(feeling of warmth and/or redness), chest tightness or pain with heart
palpitations, anxiety, and trouble breathing. These symptoms generally
appear within minutes of an injection, last about 15 minutes, and go
away by themselves without further problems. During the postmarketing
period, there have been reports of patients with similar symptoms who
received emergency medical care. If symptoms become severe, patients
should call the emergency phone number in their area. Patients
should call their doctor right away if they develop hives, skin rash
with irritation, dizziness, sweating, chest pain, trouble breathing, or
severe pain at the injection site. If any of the above occurs, patients
should not give themselves any more injections until their doctor tells
them to begin again. Chest pain may occur either as part of the
immediate postinjection reaction or on its own. This pain should only
last a few minutes. Patients may experience more than one such episode,
usually beginning at least one month after starting treatment. Patients
should tell their doctor if they experience chest pain that lasts for a
long time or feels very intense. A permanent indentation under the skin
(lipoatrophy or, rarely, necrosis) at the injection site may occur, due
to local destruction of fat tissue. Patients should follow proper
injection technique and inform their doctor of any skin changes. The
most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing, rash,
shortness of breath, and chest pain. These are not all of the possible
side effects of COPAXONE®. For a complete list, patients
should ask their doctor or pharmacist. Patients should tell their doctor
about any side effects they have while taking COPAXONE®.
Patients are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
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 potential benefits of COPAXONE® 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:
-
our specialty medicines business, including: competition for our
specialty products, especially Copaxone®, our
leading medicine, which faces competition from existing and potential
additional generic versions and orally-administered alternatives; our
ability to achieve expected results from investments in our product
pipeline; competition from companies with greater resources and
capabilities; and the effectiveness of our patents and other measures
to protect our intellectual property rights;
-
our business and operations in general, including: 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
restructuring of our manufacturing network, including potential
related labor unrest; the impact of continuing consolidation of our
distributors and customers; and variations in patent laws that may
adversely affect our ability to manufacture our products;
-
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”), including in the section
captioned “Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at www.sec.gov
and www.tevapharm.com.
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 put undue reliance on these forward-looking
statements.
1 Population-based tracking system for birth defects. The
MACDP was established in 1967 by the Centers for Disease Control and
Prevention (CDC), Emory University, and the Georgia Mental Health
Institute.
2 European network of population-based registries for the
epidemiologic surveillance of congenital anomalies
View source version on businesswire.com: http://www.businesswire.com/news/home/20170505005363/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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