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Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that key data from the Company’s multiple sclerosis (MS) franchise will be featured in over 20 presentations at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, October 2-5, 2013. Data presentations will provide new clinical insights on the effects of treatment with COPAXONE
® (glatiramer acetate injection), the world’s leading relapsing-remitting multiple sclerosis (RRMS) treatment, and the novel effects of laquinimod, Teva’s investigational oral compound, when used to treat RRMS.
"With our sixteen year legacy in providing a safe and effective treatment for RRMS, Teva continues to discover and develop treatments that positively impact patients living with this complex, debilitating disease,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd. “The continued investigation of the long-term open-label study of COPAXONE and investigation of laquinimod’s effect in MS demonstrate our ongoing focus on increasing the body of scientific knowledge available to neurologists for making appropriate treatment decisions in a rapidly evolving landscape.”
In addition to presenting data at the Congress, Teva will host two satellite symposia, “Emerging Insights in Multiple Sclerosis: Re-evaluating the Treatment Algorithm” on Thursday, October 3, 2013 from 13:00 - 14:00 CET and “Multiple Sclerosis Management: Have We Got the Focus Right?” on Friday, October 4, 2013 from 19:15 - 20:15 CET. Also during the Congress, Teva will host a roundtable event for credentialed journalists focused on the future of the MS treatment landscape and patient journey.
Data Highlights from the Teva MS Franchise
Key data being presented during ECTRIMS from Teva’s MS franchise will include twenty-year long-term clinical results from the US open-label extension study of COPAXONE
® in RRMS, analyses of pooled data from the Phase 3 BRAVO and ALLEGRO clinical trials of laquinimod and results from the open-label extension phase of the BRAVO study.
® (glatiramer acetate injection):
[P 577] Twenty years of continuous treatment of multiple sclerosis with glatiramer acetate 20mg daily: long-term clinical results of the US open-label extension study (Poster Session: Long-term treatment monitoring, October 03, 15:30 - 17:00 CET) C. Ford, D. Ladkani on behalf of the US Open-Label Glatiramer Acetate Study Group
[P 606] Bayesian analysis of laquinimod's effect on relapses and disability (Poster Session: Tools for detecting therapeutic response, October 03, 15:45 - 17:00 CET) G. Cutter, G. Comi, T. Vollmer, D. Ladkani, N. Sasson, V. Knappertz (Birmingham, US; Milan, IT; Aurora, US; Petah Tikva, Netanya, IL; Düssseldorf, DE / Frazer, US)
[P 1036] Disease progression in relapse-free patients treated with laquinimod (Poster Session: Long-term treatment monitoring, October 04, 15:30 - 17:00 CET) G. Comi, T. Vollmer, G. Cutter, N. Sasson, D. Ladkani, T. Gorfine (Milan, IT; Aurora, Birmingham, US; Netanya, Petah Tikva, IL)
[P 1055] Results of switching to laquinimod in the open-label extension phase of the BRAVO study (Poster Session: Long-term treatment monitoring, October 04, 15:30 - 17:00 CET) T. Vollmer, P.S. Sorensen, K. Selmaj, F. Zipp, E. Havrdova, J. Cohen, Y. Sidi, T. Gorfine, D. Arnold for the BRAVO Study Group
[P 1080] Evaluating the relationship between laquinimod's effects on relapse and disability progression (Poster Session: Tools for detecting therapeutic response, October 04, 15:30 - 17:00 CET) M.P. Sormani, G. Cutter, G. Comi, T. Vollmer, P.S. Sorensen, D. Ladkani, N. Sasson, V. Knappertz (Genoa, IT; Birmingham, US; Milan, IT; Aurora, US; Copenhagen, DK; Petah Tikva, Netanya, IL; Düsseldorf, DE / Frazer, US)
® (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with 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
http://copaxone.com/pdfs/PrescribingInformation.aspx. 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.
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 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
www.fda.gov/medwatch or call 1-800-FDA-1088.
Laquinimod is an oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS. The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase III laquinimod trial, CONCERTO, is evaluating two doses of the investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months. The primary outcome measure will be time to confirmed disability progression as measured by the EDSS.