Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced new results from
the PreCISe study, which demonstrated that early treatment with COPAXONE®
(glatiramer acetate injection) significantly reduced the risk of developing
clinically definite multiple sclerosis (CDMS) by 45 percent compared to placebo
(hazard ratio 0.55, p=0.0001). These data were presented as late-breaking
science at the 60th Annual Meeting of the American Academy of Neurology (AAN) in
Chicago.
Based on the PreCISE results, an application for marketing
authorization in Europe to the Medicines and Healthcare products Regulatory
Agency (MHRA) for the extension of its indication to include the treatment of
patients with a first clinical event suggestive of MS, was submitted and is
currently under review. A similar application requesting an expanded label for
COPAXONE® will also be submitted shortly with the U.S. Food and Drug
Administration (FDA).
"Clinically isolated syndrome, or CIS, is a first
neurologic episode, usually caused by inflammation or demyelination, which is
indicative of possible development of multiple sclerosis," said Giancarlo Comi,
M.D., University Vita-Salute San Raffaele, Scientific Institute San Raffaele,
Milan, Italy, and principal investigator. "The PreCISe study results clearly
demonstrate that early treatment with COPAXONE®, as early as CIS, reduces the
risk of developing MS" he added.
COPAXONE®, currently indicated for
RRMS, is a unique disease modifying treatment with a dual mode of action that
has over 10 years of prospective clinical trial data demonstrating long-term
clinical treatment benefits and good safety profile. The PreCISe results now
extend COPAXONE® effect to CIS patients, demonstrating a reduced risk of
developing Clinically Definite MS (CDMS). Furthermore, the safety profile of
COPAXONE® in the PreCISe study was consistent with the well-established safety
profile of the product based on many years of post-marketing surveillance and
over 100,000 patients treated globally with COPAXONE®.
Moshe Manor,
Group Vice President, Global Innovative Resources of Teva Pharmaceutical
Industries, Ltd., said, "These impressive results clearly demonstrate the
potency of COPAXONE® in treating early phases of multiple sclerosis. Along with
its lasting efficacy, confirmed over 10 years, it positions COPAXONE® as the
preferred treatment option for multiple sclerosis patients."
About
the Study
The multi-national, multi-center, prospective,
double-blind, randomized, Phase III study was conducted in approximately 100
centers located in the U.S., Europe, Argentina, Israel, Nordic countries,
Australia and New Zealand. It included a total of 481 patients presenting with a
single clinical episode and MRI suggestive of MS. Patients included were those
who had a unifocal disease manifestation (i.e., clinical evidence of a single
lesion). Patients received either COPAXONE® 20mg/day or placebo as a
subcutaneous injection and continued treatment for up to 36 months, unless a
second attack was experienced and they were diagnosed with CDMS. Patients who
converted to CDMS continued the trial on active treatment for an additional two
years. The primary efficacy outcome was time to CDMS, based on a second clinical
attack.
COPAXONE® (glatiramer acetate injection) was also demonstrated
to be very well tolerated in the PreCISe study, with only 16 percent overall
dropouts during the up to three-year study period, similar to that observed in
RRMS patients treated with COPAXONE®. All patients in the study participated in
a follow-up study with COPAXONE® to prospectively assess the impact of early
versus delayed treatment with COPAXONE® on the long-term course of the disease
for a total observation time of up to five years.
A pre-planned interim
analysis was performed on data accumulated from approximately 80 percent of the
three-year placebo-controlled study exposure. Results of the interim analysis,
announced in December 2007, demonstrated the proportion of patients developing
CDMS was reduced from 43 percent in the placebo group to only 25 percent in the
COPAXONE® group (p< 0.0001). The PreCISe study also demonstrated that the
25th percentile of number of days to conversion to CDMS has more than doubled by
COPAXONE® from 336 days to 722 days (hazard ratio 0.55, p=0.0005) compared with
placebo.
At the time of this analysis, the data monitoring committee
(DMC) stopped the placebo arm of the study, as COPAXONE® successfully met the
efficacy endpoint of the study.
About COPAXONE®
Current
data suggest COPAXONE® 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 COPAXONEv 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. For hardcopy releases, please see enclosed full
prescribing information.
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.
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: when and whether the proposed acquisition will be consummated,
Teva's ability to rapidly integrate Bentley's operations with its own operations
and achieve expected synergies, the diversion of management time on
merger-related issues, 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 of Allegra®,
Neurontin®, Lotrel®, Famvir®
and Protonix®, 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, 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.
Teva Pharmaceutical Industries Ltd.
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