Teva to present further results of twenty-year open-label extension study of glatiramer acetate 20 mg daily for relapsing-remitting Multiple Sclerosis

• Glatiramer acetate (GA) 20 mg daily associated with stable disease activity over the course of the twenty-year study presented at the 29th ECTRIMS congress

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced further results from a long-term, open-label extension study of glatiramer acetate (GA). The extension study was designed to evaluate the long-term neurologic disease course, and the safety and efficacy of glatiramer acetate 20 mg daily, the therapeutic agent in COPAXONE® (glatiramer acetate injection), which is indicated for reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS). Detailed study results will be presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark during poster session P577 on October 3, 2013.

“To our knowledge, glatiramer acetate is the only treatment for multiple sclerosis that has been prospectively studied for nearly two decades in a continuously monitored, long-term study,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd.

In this analysis of 74 patients, the cumulative annualized relapse rate (ARR) over the study period was 0.2, with 24.3 percent of patients remaining relapse-free through the entire observation period. Additionally, 63.3 percent of enrolled patients stayed below EDSS 4, while 79.5 percent stayed below EDSS 6 throughout the course of the study. Advancement to secondary progressive MS (SPMS), defined by a greater than 1.0-point EDSS progression (or greater than 0.5 for patients with baseline scores greater than 6) sustained for greater than or equal to 12 months without relapse, was seen in 35 patients (47 percent). Adverse events (AEs) leading to study discontinuation with incidence greater than one percent over the 20-year observation period were largely related to site reactions, while incidence of serious AEs were notably low, with no unexpected findings.

ABOUT THE OPEN-LABEL EXTENSION STUDY

The open-label extension study is a long-term clinical analysis of patients that participated in the original 36-month, randomized placebo-controlled U.S. Glatiramer Acetate Trial. The objective of the extension study was to evaluate the long-term neurologic disease course, and the safety and efficacy of glatiramer acetate 20 mg daily, in patients with relapsing-remitting multiple sclerosis. Ongoing patients in this study were continuously treated with glatiramer acetate 20 mg daily for a mean of 19.3 years (SD=1.3, range 18-21) with an average disease duration of 27.3 years. Baseline assessments for each patient in this pooled analysis were taken at the start of GA therapy.

ABOUT COPAXONE®

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 the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.

Important Safety Information about COPAXONE®

Patients allergic to glatiramer acetate or mannitol should not take COPAXONE®. Some patients report a short-term reaction right after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, patients should call the emergency phone number in their area. Patients should call their doctor right away if they develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, patients should not give themselves any more injections until their doctor tells them to begin again. Chest pain may occur either as part of the immediate postinjection reaction or on its own. This pain should only last a few minutes. Patients may experience more than one such episode, usually beginning at least one month after starting treatment. Patients should tell their doctor if they experience chest pain that lasts for a long time or feels very intense. A permanent indentation under the skin (lipoatrophy or, rarely, necrosis) at the injection site may occur, due to local destruction of fat tissue. Patients should follow proper injection technique and inform their doctor of any skin changes. 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. These are not all of the possible side effects of COPAXONE®. For a complete list, patients should ask their doctor or pharmacist. Patients should tell their doctor about any side effects they have while taking COPAXONE®.

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.