AstraZeneca fails endpoint
08.04.2013 - AstraZeneca's arthritis pill fostamatinib is proven inferior to competitor drugs in a late-stage clinical trial.
While the first-in-class oral rheumatoid (RA) arthritis drug proved to be efficient as measured by ACR20 reponse it failed to halt the progression of joint damage as compared with placebo in the OSKIRA-1 Phase III study. In December, fastamatinib was shown to be inferior in efficacy compared to Abbvie’s injectible RA blockbuster antibody Humira (adalimumab),reducing its ability to compete in the US$20bn-plus RA market. AstraZeneca’ RA pill also increased blood pressure and led to diarrhea.
"Our misgiving is that fostamatinib appears to be inferior to Humira on efficacy and now the adverse events seem to pitch it below Pfizer's Xeljanz, (– another RA pill in late-stage development –) so it is hard to see where the product will fit," said Panmure Gordon analyst Savvas Neophytou.
AstraZeneca, which currently announced the restructuring of its R&D, licensed fostamatinib in 2010 from Rigel Pharmaceuticals. However, after the current study results, analysts forecasted only low fostamatinib sales, averaging just US$171m in 2016. Humira, by contrast, has annual worldwide sales of more than $9 billion but has become under pressure by new RA drugs such as Roche’s RoActemra.
With last year's loss of exclusivity on schizophrenia drug Seroquel, and Nexium for stomach acid and cholesterol fighter Crestor set for U.S. patent expiries in 2014 and 2016, AstraZeneca faces one of the industry's steepest "cliffs" of patent expiries.