“The results of the late-stage trials did not measure up to the promising results we saw earlier in development.”
AstraZeneca said it will not proceed with a regulatory filing and will return to Rigel Pharmaceuticals all rights to fostamatinib, an oral treatment for rheumatoid arthritis. The drugmaker said its decision is based on mixed top-line results in two pivotal trials in patients that had not responded adequately to currently approved treatment regimens.
The termination could deal a significant blow to Rigel, which has no other near-term commercialization prospects in its pipeline. Its deal with AstraZeneca, announced in February 2010, had come with a $100 million upfront payment to Rigel and the potential for another $1.1 billion in development and commercialization milestones. Shares of the company, already down 30 percent from their price at the beginning of the year, dropped 18 percent on the news.
The announcement was not unexpected, as data from the trials suggested that fostamatinib would have a difficult time competing with drugs currently on the market. Although response rates to regimens of fostamatinib in combination with other treatments were generally positive compared to the other treatments alone, they were not good enough to warrant going further. The drug is the first SYK tyrosine kinase inhibitor in development to treat rheumatoid arthritis.
“The results of the late-stage trials did not measure up to the promising results we saw earlier in development,” says Briggs Morrison, AstraZeneca’s chief medical officer. Response rates were not as good as those in patients using Xeljanz, Pfizer’s oral pill approved last year.
AstraZeneca had hoped that fostamatinib would be able to compete against rheumatoid arthritis market leader Humira, which is injected, and new entrant Xeljanz.
Now the drugmaker will halt development and take a pre-tax impairment charge of $140 million to R&D expenses in the second quarter of 2013 for the intangible assets relating to fostamatinib. Because this charge is excluded from its core financial measures, it will not impact its current financial guidance for 2013, according to the company.
Rigel says it still has hopes for fostamatinib, its most advanced oral SYK inhibitor in development, and believes it still may have potential in rheumatoid arthritis, as well as other indications.
“Fostamatinib continues to demonstrate positive patient outcomes and a reasonable safety profile,” says James Gower, Rigel’s chairman and CEO. “We are looking forward to receiving and evaluating the full aggregation of AstraZeneca’s efforts on this program this summer as we consider the appropriate next steps with this product candidate.”
June 05, 2013
http://www.burrillreport.com/article-astrazeneca_ends_development_of_rigels_ra_drug.html