Five-year Study Findings Published in the Journal of the Neurological Sciences
JERUSALEM, Israel, Oct 11, 2011 (BUSINESS WIRE) --
Results from a five-year study of treatment-naive patients with
relapsing-remitting multiple sclerosis (RRMS) demonstrated that patients
treated with COPAXONE(R) (glatiramer acetate injection) showed
significant reduced loss of brain volume compared to patients treated
with other disease modifying therapies (DMTs).
Though all DMT treatment arms resulted in a reduction in brain volume
loss compared to the control group of non-treated patients, COPAXONE(R)
had a significantly better effect than both low and high dose
interferons, in reducing loss of brain volume. A paper published by Dr.
Omar Khan, detailing the study findings, "Effect of disease-modifying
therapies on brain volume in relapsing--remitting multiple sclerosis:
Results of a five-year brain MRI study," was recently published in the Journal
of the Neurological Sciences.
"These data represent the importance of ongoing research in a practical
clinical setting to better understand multiple sclerosis and the impact
of therapy on the course of the disease ," said Jon Congleton, Senior
Vice President and General Manager, Teva Neuroscience. "Not only does
this study highlight the benefit of COPAXONE(R) in reducing
brain volume loss, it underscores the value of early treatment in
influencing long-term outcomes."
Brain volume loss in multiple sclerosis patients exceeds the rate of
healthy control groups. Brain volume loss, sometimes referred to as
atrophy, may be correlated with cognitive and physical deficits. Modern
magnetic resonance (MR) techniques can reliably measure loss of brain
volume over time.
ABOUT THE STUDY
In the study, the COPAXONE(R) treatment arm resulted in a -2.27
percent change in brain volume (PCVB) as compared to baseline versus
-2.62 percent for Avonex(R) (low-dose interferon), -3.21
percent for Betaseron(R)/Rebif(R) (high-dose
interferon).
This was a retrospective study in which the brain magnetic resonance
imaging (MRI) scans of 275 RRMS patients treated with DMTs were examined
with Structural Image Evaluation, using Normalization of Atrophy
(SIENA). Data analysis was conducted in 2007-08 and the study period
included patients who started DMTs in 2001-02 and subsequently received
the same DMT for five years. Inclusion criteria for the study were
diagnosis of clinically definite RRMS, disease duration of five years or
less at the time of initiating DMT and treatment-naive prior to
initiation of DMT at onset of study observation period. Untreated RRMS
patients with follow-up ranging from eight to 24 months were enrolled as
controls. All untreated patients also had prior brain MRI scans on no
therapy that could be analyzed with SIENA, so that their rate of brain
volume loss was annualized and then projected over five years assuming a
constant rate of brain volume loss over five years.
121 patients in the study were treated with COPAXONE(R), 101
were treated with Betaseron(R) or Rebif(R) and 53 were
treated with Avonex(R). All patients had brain MRI scans (at
onset of DMT and five years later) on the same 1.5T scanner. Image
analysis was performed blinded to treatment allocation.
The study was supported by Wayne State University Neuroscience Program.
Preliminary results from this study were presented at the American
Academy of Neurology annual meeting in 2008.
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. 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. In North America,
COPAXONE(R) is marketed by Teva Neuroscience, Inc., which is a
subsidiary of Teva Pharmaceutical Industries Ltd. In Europe, COPAXONE(R)
is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis.
COPAXONE(R) is a registered trademark of Teva Pharmaceutical
Industries Ltd.
See additional important information at:
http://www.sharedsolutions.com/pdfs/PrescribingInformation.aspx
or call 1-800-887-8100 for electronic releases.
ABOUT TEVA
Teva Pharmaceutical Industries Ltd.
/quotes/zigman/64731/quotes/nls/teva TEVA
+0.58%
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 neurological, respiratory and women's health
therapeutic areas as well as biologics. Teva currently employs
approximately 42,000 people around the world and reached $16.1 billion
in net sales in 2010.
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.