Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced top-line results
from a Phase III study designed to assess the efficacy, safety and tolerability
of glatiramer acetate (GA) 40mg as compared to the approved COPAXONE
20mg in the treatment of relapsing-remitting multiple sclerosis (RRMS). The 40mg
dose did not demonstrate increased efficacy in reducing the relapse rate;
however, the higher dose maintained the favorable safety and tolerability
profile of COPAXONE® 20mg.
Seventy-eight percent (78%) of COPAXONE® 20mg
treated patients remained relapse-free throughout the study. Moreover, patients
that completed one year of treatment with COPAXONE® 20mg experienced a very low
annualized relapse rate of 0.27. This robust effect was also reflected in a
remarkable reduction of inflammatory activity as measured by MRI.
the trial did not demonstrate an enhanced efficacy at the higher dose level, the
study reaffirms that COPAXONE® 20mg, the leading multiple sclerosis therapy,
remains the optimal treatment dose with unmatched long term efficacy confirmed
over 10 years," said Moshe Manor, Group Vice President - Global Innovative
Resources. "Teva is committed to ongoing research in the field of multiple
sclerosis and will continue to move forward towards providing additional
treatment options to multiple sclerosis patients".
Teva will continue to
analyze the study results to better understand the effect of GA 40mg on
patients. The Company is also evaluating the use of GA for additional
indications. About the Study
A randomized, double-blind
study, designed to assess the efficacy, safety and tolerability of 40mg
glatiramer acetate, as compared to the currently approved COPAXONE® (glatiramer
acetate) 20mg dose.
The study was conducted in 136 centers in North
America, Argentina, Europe and Israel, and included 1,155 patients with RRMS.
The trial's primary clinical outcome measure was rate of confirmed relapses.
Current data suggest COPAXONE®
(glatiramer acetate injection) is a selective MHC (Major Histocompatability
Complex) class II modulator. COPAXONE® is indicated for the reduction of the
frequency of relapses in RRMS. COPAXONE® is very well tolerated and the most
common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump
or an indentation at the site of injection, weakness, infection, pain, nausea,
joint pain, anxiety and muscle stiffness.
COPAXONE® is now approved in
51 countries worldwide, including the United States, all European countries,
Canada, Mexico, Australia and Israel. In Europe, COPAXONE® is marketed by Teva
Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE®
is marketed by Teva Neuroscience, Inc.
See additional important
information at http://www.COPAXONE.com/pi/index.html
or call 1-800-887-8100
for electronic releases. About Multiple Sclerosis
Multiple Sclerosis (MS) is the leading cause of neurological
disability in young adults. It is estimated that 400,000 people in the United
States are affected by this disease, and that over one million people are
affected worldwide. MS is a progressive, demyelinating disease of the central
nervous system affecting the brain, spinal cord and optic nerves.
Patients with MS may experience physical symptoms and/or cognitive
impairments, including weakness, fatigue, ataxia, physical dysfunction, bladder
and bowel problems, sensory effects, and visual impairment. MS also has a
significant impact on the sufferers' social functioning and overall quality of
life. About Teva
Teva Pharmaceutical Industries Ltd.,
headquartered in Israel, is among the top 20 pharmaceutical companies in the
world and is the world's leading generic pharmaceutical company. The Company
develops, manufactures and markets generic and innovative human pharmaceuticals
and active pharmaceutical ingredients, as well as animal health pharmaceutical
products. Over 80 percent of Teva's sales are in North America and Europe.
Teva's innovative R&D focuses on developing novel drugs for diseases of the
central nervous system. http://www.tevapharm.comSafe Harbor Statement under
the U. S. Private Securities Litigation Reform Act of 1995
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 Teva's 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: Teva's ability to accurately predict future market conditions,
potential liability for sales of generic products prior to a final resolution of
outstanding patent litigation, including that relating to the generic versions
®, Lotrel®, Famvir
®, Teva's ability to successfully develop and
commercialize additional pharmaceutical products, the introduction of competing
generic equivalents, the extent to which Teva may obtain U.S. market exclusivity
for certain of its new generic products and regulatory changes that may prevent
Teva from utilizing exclusivity periods, competition from brand-name companies
that are under increased pressure to counter generic products, or competitors
that seek to delay the introduction of generic products, the impact of
consolidation of our distributors and customers, the effects of competition on
our innovative products, especially Copaxone® sales, the impact of
pharmaceutical industry regulation and pending legislation that could affect the
pharmaceutical industry, the difficulty of predicting U.S.
Food and Drug
Administration, European Medicines Agency and other regulatory authority
approvals, the regulatory environment and changes in the health policies and
structures of various countries, our ability to achieve expected results though
our innovative R&D efforts, Teva's ability to successfully identify,
consummate and integrate acquisitions (including the pending acquisition of
Bentley Pharmaceuticals, Inc.), potential exposure to product liability claims
to the extent not covered by insurance, dependence on the effectiveness of our
patents and other protections for innovative products, significant operations
worldwide that may be adversely affected by terrorism, political or economical
instability or major hostilities, supply interruptions or delays that could
result from the complex manufacturing of our products and our global supply
chain, environmental risks, fluctuations in currency, exchange and interest
rates, and other factors that are discussed in Teva's Annual Report on Form 20-F
and its other filings with the U.S. Securities and Exchange Commission.
Forward-looking statements speak only as of the date on which they are made and
the Company undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or otherwise.
Pharmaceutical Industries Ltd.