Data on Higher Dose of Copaxone and Data Showing Copaxone is Most Cost Effective
Data Published in Neurology Showed That Higher Dose of Copaxone Increased Efficacy in Relapsing-remitting Multiple Sclerosis (RRMS)
Doubled Dose of COPAXONE Maintained Proven Safety Profile and
Further Reduced Relapses and Lesions
JERUSALEM, Israel, April 17, 2007 – A 9-month, randomized,
double-blind, parallel-group Phase II study of 90 patients
comparing a 40 mg dose of COPAXONE given daily to the
currently approved COPAXONE 20 mg dose showed a 38 percent
greater reduction in inflammatory disease activity as measured by
magnetic resonance images (MRI) of the brain. In addition, patients
taking COPAXONE 40 mg experienced a reduced mean on-trial
relapse rate of 77 percent when compared to annual relapse rate
prior to entry, as compared to 62 percent with COPAXONE 20
mg.
The results of this study, entitled “Randomized,
double-blind, dose-comparison of glatiramer acetate in
relapsing-remitting MS,” were published in a recent issue of
Neurology. The study can be accessed at: http://www.neurology.org/cgi/content/abstract/68/12/939.
"COPAXONE is an established RRMS therapy with more than 12
years of clinical research and experience supporting its efficacy
and safety. The recently published data demonstrated that a 40
mg dose was well tolerated, with a safety profile similar to the
currently available 20 mg dose," said Jeffrey A. Cohen, M.D.,
Director of the Experimental Therapeutics Program at Cleveland
Clinic's Mellen Center for MS Treatment and Research and
Coordinating Principal Investigator of the study. "In addition, the
results suggested that a 40 mg dose of COPAXONE may provide
better control of disease activity, and justify additional research
on the therapeutic effect of higher dosages of this drug."
Based upon the results of this study, a large-scale Phase III study
designed to confirm the higher efficacy of COPAXONE with the
increased dose has been initiated. The study, entitled FORTE (FORTy
mg Efficacy of glatiramer acetate), was launched July, 2006, in 137
centers across North America, Europe, Argentina and Israel.
Recruitment of approximately 1,000 patients is expected to be
completed in May 2007. These dossiers, including these data, are
expected to be submitted to the U.S. Food and Drug Administration
in 2008.
Phase II Study Design and Results
The study was a randomized, double-blind, parallel-group study
conducted at 18 centers in the U.S. in 90 patients with RRMS. The
study evaluated the effect of 40 mg of COPAXONE (glatiramer
acetate injection) given daily versus 20 mg of COPAXONE on
disease activity as measured by MRI and clinical relapses, as well
as the safety and tolerability of the 40 mg dose over a period of 9
months. Patients that qualified for this study had
clinically-definite MS, had experienced a relapse in the previous
year, had at least one Gd-enhancing lesion at screening visit, and
had a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5.
Patients were randomized in equal numbers to receive either 40 mg
or 20 mg of COPAXONE . All patients underwent an MRI at baseline,
and then at months 3, 7, 8 and 9. Neurological examinations were
performed at screening, baseline, and again at months 3, 6 and 9,
and suspected on-trial relapses were confirmed at an unscheduled
visit within 7 days.
COPAXONE 40 mg showed a 38 percent greater reduction of
inflammatory disease activity as measured by mean cumulative number
of Gd-enhancing T1 MRI lesions versus COPAXONE 20 mg
(p=0.0898). The benefit of the 40 mg dose was observed in as soon
as 3 months (p=0.005) through MRI measurement. When compared to
baseline numbers, the risk of having MRI activity (Gd-enhancement)
in the 40 mg group at months 7, 8 and 9 was reduced by 75 percent
(p<0.0001), compared to 65 percent in patients receiving the 20
mg dose (p<0.0001).
Relapse rates were also lower in patients who received the 40 mg
dose of COPAXONE , when compared to those who received 20 mg dose
(0.34 versus 0.57, respectively). Patients on 40 mg dose of
COPAXONE experienced a reduced on-trial mean relapse rate of
77 percent when compared to the annual relapse rate prior to entry,
versus patients who received the 20 mg dose (62 percent reduction).
The time to the first relapse was significantly delayed from 80
days in the 20 mg group to 213 days in the 40 mg group (p =
0.0367). The overall safety profile was similar to that of the 20
mg dose. Some features of injection site reactions and immediate
post-injection reactions were more common.
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 two
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 COPAXONE
COPAXONE is indicated for the reduction of the frequency of
relapses in RRMS. The most common side effects of COPAXONE
are redness, pain, swelling, itching, 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 47 countries worldwide, including
the United States, Canada, Mexico, Australia, Israel, and all
European countries. In North America, COPAXONE is marketed by
Teva Neuroscience, Inc., which is a subsidiary of Teva
Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe,
COPAXONE is marketed by Teva Pharmaceutical Industries Ltd.
and sanofi-aventis. COPAXONE is a registered trademark of
Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is
among the top 20 pharmaceutical companies in the world and is the
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. Close to 90 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.
See additional important information at http://www.copaxone.com/pi/index.html
or call 1-800-887-8100 for electronic releases. For hardcopy
releases, please see enclosed full prescribing information.
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 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 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, potential
liability for sales of generic products prior to a final resolution
of outstanding patent litigation, including that relating to the
generic versions of Allegra and Neurontin , 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,
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.
Jeffrey Cohen, M.D., is a member of Teva’s Scientific
Advisory Board.
###
Contacts:
Dan Suesskind
Chief Financial Officer
Teva Pharmaceutical Industries Ltd.
(011) 972-2-589-2840
George Barrett
President and CEO
Teva North America
(215) 591-3030
Liraz Kalif / Kevin Mannix
Teva Investor Relations
(011) 972-3-926-7281 / (215) 591-8912
Posted: April 2007
