<0> Teva Pharmaceutical Industries Ltd.IR:United States 215-591-8912or215-591-3033orIsrael 972 (3) 926-7656orPR:Israel 972 (3) 926-7687orUnited States 215-591-8974or215-284-0213 </0>
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced new data from the open-label Phase IIIb atiramer cetate low frequeny safety and patent xpeience (GLACIER) study, comparing the safety and tolerability of three-times-a-week COPAXONE (glatiramer acetate injection) 40 mg to daily COPAXONE 20 mg in patients with relapsing-remitting multiple sclerosis (RRMS). During a platform presentation this week, the results from the GLACIER study were shared at the MS Boston 2014: Joint ACTRIMS-ECTRIMS Meeting being held in Boston, Massachusetts.
The primary endpoint of the GLACIER study, the adjusted mean annualized rate of injection-related adverse events (IRAEs), was achieved with a 50 percent reduction with the three-times-a-week COPAXONE 40 mg dosing regimen versus the daily COPAXONE 20 mg regimen. In a post-hoc analysis, a similar reduction in moderate/severe IRAEs was observed with the less frequent, three-times-a-week COPAXONE 40 mg arm relative to the daily COPAXONE 20 mg arm.
“We’re pleased these results provide supportive data that fewer injections with three-times-a-week COPAXONE 40 mg resulted in half as many reported IRAEs compared to the number of IRAEs with the COPAXONE 20 mg once-daily dosing regimen,” said Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer.
In the GLACIER study, 209 patients who had received daily COPAXONE 20 mg for an average of 6.7 years, from 30 U.S. sites were randomized to receive COPAXONE 40 mg (n=108) or COPAXONE 20 mg (n=101). Patients were then assessed in the open-label design at months 1, 2 and 4. IRAEs included all local injection-site reactions (ISRs) and symptoms related to immediate post-injection reactions (IPIR; e.g., flushing, palpitations, anxiety, dyspnea) and were determined through patient diaries. Patient reported ISRs were classified as mild, moderate or severe. One patient in the 40 mg COPAXONE arm withdrew due to injection site necrosis. The overall safety was consistent with prior experience, and the study results will be submitted to a peer-reviewed publication.
“The less frequent IRAEs resulting from the reduction of dosing frequency from daily to three-times-a-week is an additional consideration for patients when making treatment decisions,” said Dr. Jerry Wolinsky, Bartels Family and Opal C. Rankin Professor of Neurology at The University of Texas Medical School at Houston and principal investigator of the GLACIER study. “This is useful data for physicians counseling their patients interested in transitioning from a daily to three-times-a-week injection schedule.”
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: 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.
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. 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 postinjection 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 or call 1-800-FDA-1088.
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 about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory 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.