Laquinimod's modest efficacy means it is no threat to Novartis' Gilenya in MS, says Nomura

Commenting on the failure of Teva Pharmaceutical Industries’ (Nasdaq: TEVA) Phase III trial for multiple sclerosis drug candidate laquinimod (BRAVO) to meet the primary endpoint of reducing annualized relapse rates (ARR) versus placebo (The Pharma Letter August 2), Nomura analyst Amit Roy sees the drug as no threat to Swiss drug major Novartis’ (NOVN: VX) already marketed Gilenya (fingolimod). He has a buy rating on Novartis, with a share price target of 65.00 Swiss francs, compared to the current 48.50 franc level.

He pointed out that, only when study arms were adjusted to re-balance certain baseline criteria (brain lesions measured by MRI) did laquinimod show modest reduction in ARR (21.3% versus placebo), which appears no better than Avonex (interferon beta 1a), 27% reduction versus placebo. In Dr Roy’s view, post-study adjustments may introduce bias and be questioned by regulators, noting that:

• Adjusted BRAVO data is in line with Phase II ALLEGRO trial, where relapse rate reduction with laquinimod (-75% from 1.2 to 0.305) is not much higher than the 70% reduction (1.3 to 0.395) observed with placebo. This modest benefit equates to one relapse every 2.5 years versus Gilenya‘s every 5.5 years versus placebo (or 6.25 years vs Avonex). Laquinimod’s best-case Avonex-like efficacy and reduction in disability progression fails to differentiate it from Gilenya; he awaits safety data.