Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that 14 company-sponsored COPAXONE ® and laquinimod abstracts, including three oral presentations, were highlighted at the 66th annual American Academy of Neurology (AAN) meeting in Philadelphia, Pa. New data presented adds to the understanding of the clinical utility of three-times-a-week COPAXONE ® 40 mg/mL and provides additional findings on its efficacy, safety, and tolerability profile.
Results from the open-label Phase IIIb GLatiramer Acetate low frequen Cy safety and pat Ient Expe Rience (GLACIER) study, comparing the safety and tolerability of new three-times-a-week COPAXONE ® 40 mg/mL to daily COPAXONE ® 20 mg/mL, were presented during an oral session today by principal investor, Dr. Jerry Wolinsky, Bartels Family and Opal C. Rankin Professor of Neurology at The University of Texas Medical School at Houston.
“The clinical and real-world significance of the data presented underscore Teva’s commitment to developing solutions to address unmet patient needs,” said Dr. Michael Hayden, president and chief scientific officer at Teva Pharmaceutical Industries, Ltd. “Our historical leadership, and deep understanding of MS patients' needs, keeps us at the leading edge of MS therapy development, with a single-minded focus on supporting the MS community in the provision of the highest standards of care possible, now and in the future.”
Additional data presented elucidate the potential therapeutic role of the investigational drug laquinimod in relapsing and progressive forms of MS.Data highlights from Teva’s MS franchise (Results available through the AAN at http://www.abstracts2view.com/aan/sessionindex.php): COPAXONE ® (glatiramer acetate injection):
- [S31.002] GLACIER: An open-label, randomized, multicenter study to assess safety and tolerability of glatiramer acetate 40 mg/1ml 3-times weekly versus 20 mg/1ml daily in patients with relapsing-remitting multiple sclerosis (Platform Session: General Neurology I, Wednesday, April 30, 2:15 p.m.) J. Wolinsky, T. Borresen, D. Dietrich, B. Gilder, Y. Sidi, V. Knappertz, S. Kolodny
- [S31.003] 24-Month efficacy and safety of glatiramer acetate 40mg/1ml 3-times weekly: Open-label extension study of the GALA trial in subjects with relapsing-remitting multiple sclerosis (Platform Session: General Neurology I, Wednesday, April 30, 2:30 p.m.) O. Khan, P. Rieckmann, A. Boyko, K. Selmaj, H. Barkay, S. Kolodny, R. Zivadinov
- [P1.212] Gene expression studies comparing glatiramer acetate and proposed generics (Poster Session I: MS and CNS Inflammatory Disease: Treatment Mechanisms of Action, Monday, April 28, 3:00 p.m.-6:30 p.m.) B. Zeskind, F. Towfic, J. Funt, K. Fowler, S. Bakshi, E. Blaugrund, S. Kolitz, M. Artyomov, M. Hayden, I. Grossman, L. Hayardeny, R. Schwartz
- [P3.026] Conversion of new active MRI lesions at 6 months to T1 Hypointense 'black holes' at 12 months in RRMS subjects from the GALA study (Poster Session III: General Neurology II, Tuesday, April 29, 3:00 p.m.-6:30 p.m.) R. Zivadinov, J. Steinerman, V. Knappertz, H. Barkay, O. Khan
- [P3.196] MRI correlates of disability: Neuroimaging substudy at 20 years in the ongoing US glatiramer acetate open-label extension study (Poster Session III: MS and CNS Inflammatory Disease: Clinical Trials Outcomes, Tuesday, April 29, 3:00 p.m.-6:30 p.m.) O. Khan, F. Bao, M. Shah, G. Ramesh, C. Caon, C. Santiago, Z. Latif, R. Aronov, I. Zak, Y. Sidi, S. Kolodny
- [S4.001] Rationale for advancing laquinimod for progressive MS: Evidence from large clinical trials in RRMS (Platform Session: MS and CNS Inflammatory Disease: Clinical Trials, Tuesday, April 29, 1:00 p.m.) G.Comi, M. Pia Sormani, G. Giovannoni, D. Ladkani, N. Sasson, T. Gorfine, V. Knappertz
- [P3.195] Mediation of the effect of laquinimod on disability progression in relapsing-remitting multiple sclerosis (RRMS) (Poster Session III: MS and CNS Inflammatory Disease: Clinical Trials Outcomes, Tuesday, April 29, 3:00 p.m.-6:30 p.m.) G. Comi, D. Ladkani, T. Vollmer, M. Pia Sormani, Y. Sidi, V. Knappertz
- [P1.203] Laquinimod modulates genes encoding cell migration in multiple sclerosis (Poster Session I: MS and CNS Inflammatory Disease: Treatment Mechanisms of Action, Monday, April 28, 3:00 p.m.-6:30 p.m.) R. Zilkha-Falb, M. Gurevich, L. Hayardeny Nisimov, A. Achiron