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|October 08, 2012 8:01 a.m.|
|New Data Presented at the 28th ECTRIMS Congress Showcase Teva’s Ongoing Commitment to Multiple Sclerosis Research|
Highlights Include Late-Breaking Presentation of the Phase III GALA Results Evaluating Glatiramer Acetate 40 mg/1 ml
"For more than 20, years Teva has been at the forefront of MS research and development focused on providing effective and safe treatments aimed at meeting the needs of patients’ living with this complex, often debilitating disease,” said Dr.
In addition to the data being presented at the
Teva-Sponsored Data Highlights Include:
The multinational randomized, double-blind placebo-controlled
Laquinimod is an oral, once-daily investigational central nervous system (CNS)-active immunomodulator with a novel mechanism of action in development for the treatment of RRMS. Multiple presentations at ECTRIMS further demonstrate the clinical benefits of this unique compound. Ongoing analyses from the open-label extension phase of the ALLEGRO trial assessing the effect on disease course in patients treated with laquinimod for three years, as well as in patients originally treated with placebo and switched to laquinimod treatment for one year, may provide further possible evidence surrounding the effectiveness of the compound in decreasing relapse rates. Further analyses on other clinical endpoints such as disability and safety will be discussed. Results from an additional study using several magnetic resonance imaging (MRI) techniques sensitive to irreversible tissue damage such as measurements of brain volume or magnetic transfer ratio (MTR) were consistent with the positive impact on disability progression demonstrated with the therapy. Key posters include:
Results from the Therapy Optimization in Multiple Sclerosis (TOP MS) study, the largest prospective Phase IV study conducted in MS, provide insight into the impact of adherence to therapy as well as the effect of progression of symptoms on MS patients’ health outcomes and daily activities. Presentation of data will show that better adherence to disease-modifying treatment (DMT) was associated with fewer relapses, as measured by the medication possession ratio (MPR). Additionally, independent of non-adherence to therapy, prior use of one or more MS therapies was associated with increased risk of relapse. In terms of MS symptom effects, a separate presentation will show that change in fatigue severity scale (FSS) was observed as a significant predictor of percent time missed from work. Key posters include:
The North American Research Committee on Multiple Sclerosis (NARCOMS) is a global longitudinal MS registry that collects information regarding the long-term effects of DMT among an active database of over 35,000 MS patients. Researchers analyzed data from the registry to describe the disease characteristics of MS patients who have continuously taken the same DMT for a minimum of five years and to evaluate the likelihood of changes in Patient-Determined Disease Steps (PDDS) and Performance Scales (PS). Results will reveal factors that may inform treatment decisions among clinicians. Key posters include:
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 worldwide, including
Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of MS. In animal models, laquinimod crosses the blood-brain barrier to potentially have a direct effect on the neurodegenerative processes of MS. The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies, ALLEGRO and
In addition to the MS clinical studies, laquinimod is currently in Phase II of development for Crohn's disease and Lupus.
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