Data presented at the 63rd Annual Meeting of the American Academy of Neurology (AAN) in Honolulu, HI

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced preliminary data from two studies, Coptimize and QualiCop. 
The global Coptimize study, which followed 688 patients from 19 countries, demonstrated that patients who switched to Copaxone® (glatiramer acetate injection) from other approved disease modifying therapies experienced a significant reduction of 61 percent (p<0.0001; signed rank test) in ARR. Switching to Copaxone® treatment also halted the progression of disability of patients in the trial. A majority of patients reported better overall wellbeing and less adverse events after switching to Copaxone®.

The QualiCop study indicated a significant improvement of cognitive function and depressive symptoms over 24 months. Additionally, patients on Copaxone® experienced improved overall multiple sclerosis functional composite (MSFC) scores; the MSFC measures leg function/ambulation, arm/hand function and cognitive function. The study followed 734 patients who were either treatment nave or previously-treated with other approved injectable and infused disease modifying therapies for relapsing-remitting multiple sclerosis. In both studies, patients treated with Copaxone also demonstrated stable EDSS (no disease progression) during the study periods.

"These data provide evidence that multiple sclerosis (MS) patients who are not responding optimally to other therapies may benefit from treatment with glatiramer acetate (GA)," said Professor Tjalf Ziemssen, MD, Head of MS center Dresden, Germany and principal investigator on both the Coptimize and QualiCop studies. "These data demonstrated beneficial effects of Copaxone® treatment beyond the already established effect on clinical disease activity and safety profile. Improvements in factors that impact patients' quality of life measures such as mobility, depression and cognitive performance, may lead to improved compliance and adherence to therapy." 
The results of both the Coptimize and QualiCop studies were presented this week at the 63rd Annual Meeting of the American Academy of Neurology (AAN) in Honolulu, Hawaii

About the Coptimize Study

The Coptimize study is an international, non-interventional, longitudinal study, recruiting relapsing-remitting multiple sclerosis (RRMS) patients switching to Copaxone® from other injectable and infused disease modifying therapies approved for RRMS within three to six months of screening. The 150 clinics in 19 countries participating in the Coptimize study collected data from about 688 enrolled patients, and leveraged a web-based database to document patients' switch rationale and outcomes, including relapse rate, expanded disability status scale (EDSS), magnetic resonance imaging (MRI), QoL, fatigue and depression, as well as safety and tolerability measures. 

The median disease duration of patients in the study was one year, and the median EDSS score at the time of switch was 2.5. The analysis included 648 patients, most of whom reported better efficacy and safety profiles following a switch to Copaxone® treatment (p<0.0001; binomial test). 

Among 428 patients who had at least one visit post month 0, there was a significant reduction of 61 percent in ARR from 0.85 pre-switch to 0.33 post-switch to COPAXONE® (p<0.0001; signed rank test). Disability progressions as measured by EDSS were stable during the 12 months. 

About the QualiCop Study 

The QualiCop study is a prospective, observational, open label, multicenter non-interventional study of treatment-na’ve and previously treated RRMS patients. Over the course of the two-year study, a series of 11 examinations were conducted using various assessments and questionnaires to evaluate QoL (functional assessment of multiple sclerosis, FAMS), fatigue (fatigue scale for motor and cognitive functions, FSMC) and cognition (Paced Auditory Serial Addition Test, PASAT) and Multiple Sclerosis Inventory Cognition, MUSIC tests).
Compared to baseline findings indicate that treatment with Copaxone® resulted in improved overall MSFC scores. A robust improvement in cognitive function in patients treated with Copaxone® was observed as measured by the PASAT and MUSIC test (p<0.001). 

ABOUT COPAXONE® 

Copaxone® 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. 

Copaxone® (glatiramer acetate injection) is now approved in more than 50 countries worldwide, including the United States, Russia, 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. In Europe, Copaxone® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.