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Teva Pharmaceutical Industries: Teva Announces Approval Of Three-Times-A-Week COPAXONE

The following excerpt is from the company's SEC filing.

40 mg/mL in Russia

for the Treatment of Relapsing-Remitting Multiple Sclerosis

JERUSALEM, October 08, 2015

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Russian Ministry of Health has approved the Marketing Authorization license (MA) for three-times-a-week COPAXONE

(glatiramer acetate injection) 40 mg/mL, a new dose of COPAXONE

, for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). This formulation of COPAXONE

will allow for a less frequent dosing regimen for patients with RRMS in Russia.

For more than 20 years, Teva has been committed to safe and tolerable treatments options for patients with multiple sclerosis. The availability of three-times-a-week COPAXONE

40 mg/mL is a significant advancement for the multiple sclerosis patient community in Russia, said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. The new three-times-a-week COPAXONE

40 mg/mL is the same therapy that patients and physicians know and trust with almost 60 percent fewer injections per year compared to the current daily COPAXONE

20 mg/mL formulation. In the U.S., for example, more than 70 percent of patients currently receiving glatiramer acetate treatment are receiving the COPAXONE

40 mg/mL formulation.

The Russian Ministry of Health approval was based primarily on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study. In the GALA study, which included more than 1,400 patients, the 40 mg/ml dosage of COPAXONE

administered subcutaneously three times per week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with RRMS.


20 mg, approved in Russia in 2010, continues to be available in Russia.


(glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of 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:

. For hardcopy releases, please see enclosed full prescribing information. The COPAXONE

brand is 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...