Teva Pharmaceutical’s new investigational treatment for MS

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today top-line results from the open-label extension of the Phase III ALLEGRO study that assessed the progression of disability and safety of oral laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis (RRMS) patients. The study compared the effectiveness of laquinimod in patients who received 36 months (early-start) versus those who received 24 months of laquinimod treatment (delayed-start).

Laquinimod is an oral, once daily, investigational drug in Phase III studies for RRMS.

Of the 864 RRMS patients who participated in the original double-blind ALLEGRO trial, 97% participated in the open-label extension and 87% completed one year of the open-label phase. Overall, during the entire conduct of the study (double blind and open label phase), early start patients were less likely to experience disease progression than those with a delayed start of Laquinimod (11.8% risk of confirmed disability progression vs 16.7%, HR = 0.62, p < 0.0038).

“The results of this longer-term study of laquinimod suggest a robust benefit in terms of early treatment for RRMS and in potentially delaying disability, which is a primary goal of RRMS treatment,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries, Ltd. “The development of laquinimod’s clinical profile has been full of exciting revelations about the compound’s unique mechanism of action, and we were dually encouraged by the preclinical data which demonstrated a potential direct effect on neuroregenerative processes.”

The study also supports a favorable safety and tolerability profile of laquinimod in RRMS patients. No new safety concerns arose during the open-label phase.

Additionally, a preclinical study in animal models demonstrated the ability of laquinimod to increase the myelinated axons and mature oligodendrocytes in the brain. This data suggests laquinimod has potential restorative and anti-inflammatory properties.

Results of both studies will be shared with the scientific community following a full analysis of the data.

ABOUT THE STUDIES

Additional detail can be found on the AAN website: http://www.abstracts2view.com/aan/

[S41.004] Comparison of Early and Delayed Oral Laquinimod in Patients with Relapsing-Remitting Multiple Sclerosis: Effects on Disability Progression at 36 Months in the ALLEGRO Trial

Giancarlo Comi, Milan, Italy, Douglas Jeffery, Advance, NC, Ludwig Kappos, Basel, Switzerland, Xavier Montalban, Barcelona, Spain, Alexey Boyko, Moscow, Russian Federation, Maria Rocca, Milan, Italy, Massimo Filippi, Milan, Italy

[P05.197] Therapeutic Laquinimod Treatment Restores Axon Myelination, Callosal Conduction and Motor Deficit in a Chronic Mouse Model of Multiple Sclerosis Spencer Moore, Los Angeles, CA, Gemmy Hannsun, Los Angeles, CA, Jane Yoon, Los Angeles, CA, Rhusheet Patel, Los Angeles, Timothy Yoo, Los Angeles, CA, Anna Khalaj, Los Angeles, CA, Seema Tiwari-Woodruff, Los Angeles, CA

ABOUT LAQUINIMOD

Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of MS. In animal models laquinimod crosses the blood brain barrier to potentially have a direct effect on resident CNS inflammation and neurodegeneration. 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, after which patients will continue to an active treatment period with laquinimod for additional 24 months The primary outcome measure will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).

In addition to the MS clinical studies, laquinimod is currently in clinical development for Crohn’s disease and Lupus.

ABOUT MULTIPLE SCLEROSIS

MS is the leading cause of neurological disability in young adults. It is estimated that more than 400,000 people in the United States are affected by the disease and that two million people may be affected worldwide. Multiple sclerosis is a degenerative disease of the central nervous system in which inflammation and axonal damage and loss result in the development of progressive disability.