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|December 04, 2014 10:29 a.m.|
|Teva Receives Positive Outcome in Europe for Three-Times-a-Week COPAXONE® (Glatiramer Acetate) 40 mg/ml for the Treatment of Relapsing Forms of Multiple Sclerosis (RMS)|
MHRA and other EU Member States Issue Positive Assessment Report under the Decentralized Procedure for New, Three-Times-A-Week COPAXONE® 40 mg/ml Formulation
The three-times-a-week COPAXONE® 40 mg/ml formulation will allow for an improved, less-frequent, subcutaneous dosing regimen for adults with RMS. The new formulation reduces the total number of injections by almost 60 percent, while maintaining the known benefits of once daily COPAXONE® 20 mg/ml.
“We welcome the opportunity to make COPAXONE® 40 mg/ml
available to patients with RMS in Europe,” said Rob Koremans, MD,
President and CEO of Global Specialty Medicines at Teva.
“Three-times-a-week COPAXONE® 40 mg/ml will be available in
Three-times-a-week COPAXONE® 40 mg/ml was approved by the
“Teva has been committed to the pursuit of MS research, and the
development of COPAXONE®, for more than 20 years,” commented
The RMS’s Positive Assessment Report was based primarily on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study. In the GALA study which included more than 1400 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.
Daily COPAXONE® 20 mg/ml, approved in the EU in 2000,
continues to be available in
COPAXONE® (glatiramer acetate) 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.
COPAXONE® is now approved in more than 50 countries
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially COPAXONE®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents); the possibility of
material fines, penalties and other sanctions and other adverse
consequences arising out of our ongoing FCPA investigations and related
matters; our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent and
during the timeframe intended by our cost reduction program; our ability
to identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.