New Copaxone (Glatiramer Acetate) Formulation Launched in UK

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New Copaxone® (glatiramer acetate) formulation launched in UK

Castleford, June, 2015 – Teva UK Limited (“Teva”) has announced the launch today of Copaxone® 40mg/ml three-times weekly injection.

Copaxone® 20mg/ml is currently approved for the treatment of relapsing-remitting multiple sclerosis (RRMS).1With this new formulation, patients will only have to inject themselves three times per week – compared to daily injections with the existing formulation.1

Approval was granted in December 2014 and was based on the findings from Teva’s Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study, which involved over 1,400 patients. Results demonstrated that patients dosed three-times weekly with Copaxone® 40 mg/ml experienced significantly reduced relapse rates compared to placebo at 12 months, with a safety and tolerability profile similar to that of Copaxone® 20mg/ml daily.2

Robyn Hughes, Specialty Director at Teva UK Limited, said: “We welcome the opportunity to make Copaxone®40 mg/ml available to patients with RRMS in the UK.”
DrEwan Walters, Teva UK’s Medical Director, said: “Teva has been committed to the pursuit of MS research, and the development of Copaxone®, for more than 20 years. We are proud to be able to bring to patients in the UK the option of this new, three-times weeklyCopaxone® 40 mg/ml formulation which we believe will offer patients and their healthcare professionals flexibility in choosing a dosing regimen that works best for them.”

Copaxone has been available in the UK since 2000. The three-times weekly 40 mg/ml formulation gives patients a convenient treatment option. Clinical studies have shown three-times weekly Copaxone® can maintain the benefits of relapse reduction of the once-a-day formulation, with 57 percent fewer injections.

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For media enquiries, contact the Teva UK Limited Communications team on 01977 628500, or email

Notes to Editors:

About Teva UK Limited

Teva UK Limited is one of the UK’s top ten pharmaceutical manufacturers, with a presence in the generics, branded respiratory, CNS and hospitals markets. It has the widest range of any UK generic pharmaceutical company and markets solid and liquid dose, injectable and respiratory medicines to healthcare professionals. The company is part of Teva Pharmaceutical Industries Ltd. For more information, visit

References:

1)Copaxone 40mg/ml Summary of Product Characteristics, January 2015

2)Khan O et al. Ann Neuro 2013;73:705–713

About Teva Pharmaceutical Industries Ltd

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