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Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Results of Study on Laquinimod


Thursday, 21 Mar 2013 08:00am EDT 

Active Biotech AB announced that Teva Pharmaceutical Industries Ltd and Active Biotech announced on March 21, 2013 top-line results from the open-label extension of the Phase III ALLEGRO study that assessed progression of disability and safety of oral laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis (RRMS) patients. The study compared 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 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. During the entire 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 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. 

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