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Early Study Findings Indicate Improvement in Muscle Stiffness, Pain
and Discomfort and Ability to Walk Following Discontinuation of
Interferon-beta Treatment and Transition to COPAXONE(R)
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Data Presented at the 64th Annual Meeting of the American Academy
of Neurology (AAN) in New Orleans, Louisiana
JERUSALEM, Apr 26, 2012 (BUSINESS WIRE) --Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced
interim data from a prospective, open label survey study evaluating
spasticity in patients with relapsing-remitting multiple sclerosis
(RRMS) who transitioned to COPAXONE(R) (glatiramer acetate
injection) from interferon-beta treatment. These data were presented
today at the 64th Annual Meeting of the American Academy of Neurology
(AAN) in New Orleans, Louisiana.
Interim results for the first 52 of 110 participants revealed a
significant reduction in muscle stiffness, pain and discomfort, as well
as the effect of spasticity on the ability to walk, body movements and
activities of daily living (ADLs). Improvement was also found in
reduction of total spasticity scores during the six month period.
"Spasticity, one of the more common symptoms of RRMS, can often
negatively impact patients' daily lives," said Cira Fraser PhD, RN,
ACNS-BC, Associate Professor and Graduate Faculty, Marjorie K. Unterberg
School of Nursing and Health Studies, Monmouth University, West Long
Branch, New Jersey and Principal Investigator of the study. "These data
may suggest a reduction in the key measures of spasticity in RRMS
patients who discontinued interferon-beta treatment and transitioned to
COPAXONE(R)."
The prospective longitudinal survey research study is evaluating 110
participants utilizing the Multiple Sclerosis Spasticity Scale
(MSSS-88), the Performance Scales, and a socio demographic questionnaire
completed when transitioning between treatments and at month six. Study
criteria included participants who had stopped interferon-beta treatment
within 30 days; were about to start, or started COPAXONE(R)
within the previous 21 days; had spasticity; and were able to ambulate
with unilateral support or without. Of the 52 participants, whose data
are currently being reported, 35 percent were taking medication for
spasticity prior to enrollment and during the six month period.
"These study results contribute to the body of knowledge on the
treatment of RRMS," said Jon Congleton, Teva's Senior Vice President,
Global Brand Strategic Marketing. "Through the ongoing support of
research such as this, Teva is continually working to help improve the
lives of RRMS patients."
ABOUT THE STUDY
Additional detail can be found on the AAN website: http://www.abstracts2view.com/aan/
[P07.074] A Prospective Study of Spasticity in Individuals with
Multiple Sclerosis (MS) in Transition from Interferon-Beta to Glatiramer
Acetate (Session P07: Multiple Sclerosis: Symptoms, April 26 at 2:00
PM) Cira J. Fraser, West Long Branch, NJ
ABOUT COPAXONE(R)
COPAXONE(R) is indicated for the reduction of the frequency of
relapses in relapsing-remitting multiple sclerosis, including patients
who have experienced a first clinical episode and have MRI features
consistent with multiple sclerosis.
IMPORTANT SAFETY INFORMATION
The most common side effects of COPAXONE(R) are redness, pain,
swelling, itching, or a lump at the site of injection, flushing, rash,
shortness of breath, and chest pain.
COPAXONE(R) (glatiramer acetate injection) is now approved in
more than 50 countries worldwide, including the United States, Russia,
Canada, Mexico, Australia, Israel, and all European countries.
ABOUT TEVA
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
largest generic drug maker, with a global product portfolio of more than
1,300 molecules and a direct presence in about 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 46,000 people around the world and reached $18.3 billion
in net revenues in 2011.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements are
based on management's current beliefs and expectations and involve a
number of known and unknown risks and uncertainties that could cause our
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
successfully develop and commercialize additional pharmaceutical
products, the introduction of competing generic equivalents, the extent
to which we may obtain U.S. market exclusivity for certain of our new
generic products and regulatory changes that may prevent us from
utilizing exclusivity periods, potential liability for sales of generic
products prior to a final resolution of outstanding patent litigation,
including that relating to the generic version of Protonix(R), the
extent to which any manufacturing or quality control problems damage our
reputation for high quality production, the effects of competition on
sales of our innovative products, especially Copaxone(R) (including
potential generic and oral competition for Copaxone(R)), the impact
of continuing consolidation of our distributors and customers, our
ability to identify, consummate and successfully integrate acquisitions
(including the acquisition of Cephalon), interruptions in our supply
chain or problems with our information technology systems that adversely
affect our complex manufacturing processes, intense competition in our
specialty pharmaceutical businesses, any failures to comply with the
complex Medicare and Medicaid reporting and payment obligations, our
exposure to currency fluctuations and restrictions as well as credit
risks, the effects of reforms in healthcare regulation, adverse effects
of political or economical instability, major hostilities or acts of
terrorism on our significant worldwide operations, increased government
scrutiny in both the U.S. and Europe of our agreements with brand
companies, dependence on the effectiveness of our patents and other
protections for innovative products, our ability to achieve expected
results through our innovative R&D efforts, the difficulty of predicting
U.S. Food and Drug Administration, European Medicines Agency and other
regulatory authority approvals, uncertainties surrounding the
legislative and regulatory pathway for the registration and approval of
biotechnology-based products, potentially significant impairments of
intangible assets and goodwill, potential increases in tax liabilities
resulting from challenges to our intercompany arrangements, our
potential exposure to product liability claims to the extent not covered
by insurance, the termination or expiration of governmental programs or
tax benefits, current economic conditions, any failure to retain key
personnel or to attract additional executive and managerial talent,
environmental risks and other factors that are discussed in our Annual
Report on Form 20-F and other filings with the U.S. Securities and
Exchange Commission.
SOURCE: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
Israel
Tomer Amitai, 972
(3) 926-7656
or
PR:
United States
Denise Bradley, 215-591-8974
or
Israel
Shir
Altay-Hagoel, 972 (3) 926-7590