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.
23.10.2014 Jean-Claude Juncker can breathe a sigh of relief as MEPs voted “yes” by a large majority to his team of European Union Commissioners. Previous to the vote, Juncker had shifted the EMA back to the health commissioner in response to protests.
21.10.2014 Yet another European company is looking for money on the US stock exchange – French DBV Technologies SA is all set up for its secondary listing on NASDAQ. The French biotech company hopes to rake in US$98m for its peanut allergy patches.