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|October 10, 2012|
|Teva to Present Positive Data for Glatiramer Acetate 40 mg/1 ml Given Three Times Weekly for Relapsing-Remitting Multiple Sclerosis|
- Glatiramer acetate (GA) 40 mg/1 ml three times weekly significantly
reduced annualized relapse rates (ARR)
“We are excited about the potential to offer RRMS patients another safe
and effective treatment option for this chronic and debilitating
disease,” said Dr.
In the GALA study, a one-year randomized, double-blind, placebo controlled study, GA 40 mg/1 ml significantly reduced annualized relapse rates (ARR) by 34.4 percent (p<0.0001) versus placebo. Additionally, a significant 34.4 percent reduction in the cumulative number of new and enlarging T2 lesions (p<0.0001) and a significant 44.8 percent reduction in the cumulative number of gadolinium-enhancing (GdE) legions (p<0.0001) was observed in patients treated with GA 40 mg/1 ml versus placebo. At 12 months, there was no significant difference in percent change of brain volume between GA and placebo. Discontinuation rates among the GA and placebo patient cohorts were comparable.
GA 40 mg/1 ml demonstrated a favorable safety and tolerability profile. The overall frequency of adverse events was comparable to those observed in the placebo group. The most commonly reported adverse events were injection site reactions, headaches and nasopharyngitis.
“The GALA study was aimed at evaluating an alternative dosing regimen of
COPAXONE® (20 mg/1 ml glatiramer acetate daily subcutaneous
injection), an RRMS therapy that physicians and patients have relied on
for almost two decades,” said lead study author, Dr.
Further analyses are ongoing in an open-label extension of the trial through pre-planned follow-up beyond the initial 12-month placebo-controlled phase. Teva plans to work with health authorities to determine next steps.
About the GALA Study
COPAXONE® (glatiramer acetate injection) 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® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.
See additional important information at: http://www.sharedsolutions.com/redirect/PrescribingInformation.pdf. For hardcopy releases, please see enclosed full prescribing information.
COPAXONE® is now approved in more than 50 countries
Teva's Safe Harbor Statement under the
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, including statements relating to the results
of the GALA phase III trial and the potential efficacy or future market
or marketability of glatiramer acetate 40 mg/1 ml. Following further
analysis, Teva's interpretation of the results could differ materially
depending on a number of factors, and we caution investors not to place
undue reliance on the forward-looking statements contained in this press
release as there can be no guarantee that the results from the phase III
trial discussed in this press release will be confirmed upon full
analysis of the results of the trial and additional information relating
to the safety, efficacy or tolerability of glatiramer acetate 40 mg/1 ml
may be discovered upon further analysis of data from the phase III
trial. Even if the results described in this release are confirmed upon
full analysis of the GALA study, we cannot guarantee that glatiramer
acetate 40 mg/1 ml will be approved for marketing in a timely manner, if
at all, by regulatory authorities in the EU or in the U.S. Important
factors that could cause or contribute to such differences include risks
relating to: our ability to develop and commercialize additional
pharmaceutical products, competition for our innovative products,
especially Copaxone® (including competition from innovative
orally-administered alternatives, as well as from potential generic
equivalents), competition for our generic products (including from other
pharmaceutical companies and as a result of increased governmental
pricing pressures), competition for our specialty pharmaceutical
businesses, our ability to achieve expected results through our
innovative R&D efforts, the effectiveness of our patents and other
protections for innovative products, decreasing opportunities to obtain
U.S. market exclusivity for significant new generic products, our
ability to identify, consummate and successfully integrate acquisitions
(including the acquisition of Cephalon), the effects of increased
leverage as a result of the acquisition of Cephalon, the extent to which
any manufacturing or quality control problems damage our reputation for
high quality production and require costly remediation, our potential
exposure to product liability claims to the extent not covered by
insurance, increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.