AstraZeneca abandons late-stage RA drug
pharmafile | June 5, 2013 | News story | Research and Development, Sales and Marketing | AstraZeneca, RA, Rigel
AstraZeneca is to exit development of a new rheumatoid arthritis drug, after Phase III trials produced disappointing results.
The Anglo-Swedish firm is returning rights to the drug to its partner Rigel, and the move is yet another damaging late-stage failure for the company.
Fostamatinib, is the first treatment to target the spleen tyrosine kinase (SYK) inhibitor, and as an oral treatment, promised to offer a convenient alternative to injectable drugs in the field.
But topline results from OSKIRA-2 and OSKIRA-3, the remaining pivotal Phase 3 clinical trials produced underwhelming results in patients who had failed to respond to DMARDs or to methotrexate (MTX) and a single TNF-alpha antagonist.
Briggs Morrison, MD, Executive Vice President of Global Medicines Development and Chief Medical Officer at AstraZeneca said: “The results of the late stage trials did not measure up to the promising results we saw earlier in development. We remain committed to the search for new treatments for patients with rheumatic and inflammatory diseases, with Phase II compounds in rheumatoid arthritis and lupus and Phase III compounds in gout and psoriasis.”
The decision means AstraZeneca will spend $140 million writing off the intangible assets relating to the drug, though this cost will not affect its 2013 financial guidance.
Meanwhile Rigel is not ready to give up on the drug, and says it may have applications in RA patients as well as other potential indications. The firm is to collect and review results from AZ’s development efforts in the next few months before making a decision on the molecule’s future.
Andrew McConaghie
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