JERUSALEM, Israel I April 23, 2015 I Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announces new 36-month data from the placebo-controlled and open-label extension phases of the Glatiramer Acetate Low-frequency Administration (GALA) study evaluating the efficacy and safety of three-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg/mL in patients with relapsing forms of multiple sclerosis. The data will be featured during Poster Session 7 at the 67th American Academy of Neurology (AAN) meeting in Washington, D.C. on Thursday, April 23, 2015 from 2:00 p.m. – 6:30 p.m. ET.
The study compared early start (ES) patients (n=834) who received three-times-a-week COPAXONE® 40 mg/mL for 36 months versus delayed start (DS) patients (n=419), who started COPAXONE® after the 12-month placebo-controlled phase of the trial. The data show the adjusted mean annualized relapse rate was significantly lower for ES over 36 months (0.23 vs 0.30, risk ratio [RR]=0.770; P=0.0052). In addition, early treatment with three-times-a-week COPAXONE® 40 mg/mL resulted in a sustained reduction in lesion activity and the evolution of active lesions to chronic black holes. Adverse events observed in the trial were consistent with the established COPAXONE® 40 mg/mL safety profile.
“We’re pleased to see the sustained results from early treatment with three-times-a-week COPAXONE® 40 mg/mL in this trial,” said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva. “Teva is committed to product innovation and we continue to investigate COPAXONE® to ensure patients and physicians can make informed treatment decisions.”
About COPAXONE®
COPAXONE® (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: www.CopaxonePrescribingInformation.com 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 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 post injection 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.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
SOURCE: Teva Pharmaceutical Industries
