Dampening already low expectations for an oral drug against rheumatoid arthritis, AstraZeneca ($AZN) reported today that its midstage study of fostamatinib from partner Rigel failed to show noninferiority to Abbott's ($ABT) injected blockbuster Humira. Yet the London-based drug giant, which has shown weakness in its late-stage pipeline this year, is pushing ahead with ongoing late-stage studies that will provide a case for regulatory submissions.
As AstraZeneca points out, the Phase IIb trial reporting top-line results today was intended to gauge the impact of fostamatinib as a single agent against RA. Results were mixed. Though the 280-patient study showed benefits over placebo with certain doses of the experimental kinase inhibitor, all doses of the treatment failed to match treatment with the anti-TNF therapy Humira on a score of signs and symptoms of the joint-attacking disease.
The mixed top-line results come as AstraZeneca plows ahead with a large Phase III program for fostamatinib, on which rests the company's chances to break into the market for new oral therapies against RA. Yet Pfizer ($PFE) already crossed the finish line with FDA approval last month of a different kind of oral drug called Xeljanz, which is projected to be a blockbuster seller. AstraZeneca needs a new hit drug as much as any Big Pharma player, but the prospects of fostamatinib providing such a boost have dimmed.
These latest results are "likely to limit the product's commercial potential," said Panmure Gordon analyst Savvas Neophytou, as quoted by Reuters.
AstraZeneca has been hungry for deals and collaborations to revive its pipeline after its blockbuster Seroquel fell off the patent cliff and a series of late-stage setbacks such as the failed Phase III program for the experimental antidepressant TC-5214 from Targacept ($TRGT).
Yet the company seems willing to shoot for an approval of fostamatinib even though the drug lacks the profile of a potential $1 billion annual product. It's reporting results from Phase III studies of the drug in combination with other treatments in the first half of 2013, with plans to shoot for regulatory filings for approval in the second half of next year.
- here's the release
- check out the Reuters article