Teva Pharmaceutical Industries and Active Biotech have presented a mixed set of late-stage data on their investigational oral multiple sclerosis drug laquinimod which has got analysts wondering whether the treatment has much of a future and how important it is to the Israeli major's fortunes.
Initial results from the Phase III BRAVO study, the second of two late-stage trials on laquinimod, show that the drug failed to meet its primary endpoint of reducing the annualised relapse rate when compared with placebo. However, Teva noted that the placebo and treatment study groups showed dissimilarity "in two baseline magnetic resonance imaging" characteristics and following a "pre-specified sensitivity analysis", when this imbalance was corrected, laquinimod demonstrated a significant reduction in the annualised relapse rate (21.3%) in the risk of disability progression and in brain volume loss (27.5%).
The 1131-patient study also included a reference arm in which patients were treated with Biogen Idec's Avonex (interferon beta-1a) and the data showed that patients who took Avonex had a reduction in annualised relapse rates compared to placebo. However Teva noted that the trial "was not designed to provide direct statistical comparisons of efficacy endpoints between the two active arms".
Teva still plans filings
Still, Teva was pretty enthusiastic and said the BRAVO findings support the direct effect of laquinimod and are in line with the results of the first Phase III trial, ALLEGRO. Yitzhak Peterburg, head of the firm's global branded products, said "we are encouraged by the overall outcomes achieved in the laquinimod Phase III clinical development programme, and plan to submit applications to regulatory authorities in the USA and Europe".
However his enthusiasm is not shared by most analysts. Judson Clark at Edward Jones told PharmaTimes World News that his concern is not that the drug itself is any more or less effective as a result of this study, but that the US Food and Drug Administration will not consider the adjusted data when evaluating the application. "Teva has said they don't feel they will need another supporting trial, but if regulators send them back to the drawing board, that could prove costly and time-consuming".
Way behind Novartis' Gilenya
With Novartis' MS pill Gilenya (fingolimod) already on the market and Biogen's oral treatment BG-12 (dimethyl fumarate) showing positive results, Mr Clark believes laquinimod, if approved, "could find itself behind the curve".
He added that "importantly, we continue to find the market's reaction to news surrounding the MS franchise to be interesting" as investors "seemingly write off the future of the franchise while ignoring the positive tailwinds Teva has at its back". The generic drug business is well positioned, while its MS blockbuster Copaxone (glatiramer acetate) continues to exceed expectations in the near-term. Mr Clark concluded by claiming: "Add to that a company that is reducing its dependency on its largest drug, and we see a stock that we find very attractive".