<0> Teva Pharmaceutical Industries Ltd.IR:United States, 215-591-8912, 215-591-3033orIsrael, 972 (3) 926-7656orPR:Israel, 972 (3) 926-7687orUnited States, 215-591-8974, 215-284-0213 </0>
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced that it has received a positive outcome in the decentralized procedure for its new, three-times-a-week COPAXONE (glatiramer acetate) 40 mg/ml formulation for the treatment of adults with relapsing forms of multiple sclerosis (RMS). The outcome follows a Positive Assessment Report from the United Kingdom, the Reference Member State’s Medicines and Healthcare Products Regulatory Agency (MHRA), and all Concerned Member States (CMS) in Europe who were involved in the procedure. Granting of national authorizations will happen in the near future.
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 Europe as early as the first quarter of 2015 with expected launches in Germany, Netherlands and Denmark. Launches in other EU countries are expected throughout 2015.”
Three-times-a-week COPAXONE 40 mg/ml was approved by the U.S. Food and Drug Administration in January, 2014 and, since launch, has been prescribed to more than 40,000 patients.
“Teva has been committed to the pursuit of MS research, and the development of COPAXONE, for more than 20 years,” commented Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We are proud to be able to bring to patients in Europe the option of this new, three-times-a-week-COPAXONE 40 mg/ml formulation which we believe will offer patients and their physicians flexibility in choosing a dosing regimen that works best for them.”
The RMS’s Positive Assessment Report was based primarily on data from the Phase III latiramer cetate ow-Frequency dministration (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 Europe.
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: . 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.
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.