In the battle to catch up with Novartis' Gilenya in the multiple sclerosis pill market, Teva and Biogen Idec have presented late-stage data on their respective oral offerings.
Teva's pill, laquinimod, met the main goal in the late-stage 1106-patient ALLEGRO trial, demonstrating a 23% reduction in annualised relapse rates (AAR) compared to placebo. In addition, the study showed that patients on laquinimod had a 36% reduction in progression of disability and a 33% decrease in brain atrophy, compared to placebo. There were more cases of elevated liver enzymes among patients treated with the Teva drug, which is partnered with Active Biotech of Sweden, relative to placebo, but the increases did not lead to any signs of liver problems.
The response from analysts was mixed, with many expressing disappointment that the 23% reduction in ARR was a little lower than expected. However, others focused on the reduction in progression of disability, which would appear to better than Gilenya (fingolimod), Novartis' drug which is already approved and has shown that it reduces relapses of MS by 54%.
Teva and Active Biotech plan to file for regulatory approval of laquinimod once results from the Phase III BRAVO trial are released in the third quarter. The Israeli firm's injectable drug Copaxone (glatiramer acetate) is presently the world's best-selling MS treatment.
As for Biogen, it presented positive top-line results from DEFINE, the first of two Phase III trials evaluating BG-12 (dimethyl fumarate) as an oral monotherapy in people with relapsing-remitting MS. Results showed that 240 mg of BG-12, administered either twice or three times a day, met the primary study endpoint, demonstrating a highly statistically significant reduction in the proportion of patients who relapsed at two years compared with placebo. Further analyses of DEFINE are ongoing, and detailed data will be presented at a future medical meeting.