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AstraZeneca ceases fostamatinib filings, returns rights to Rigel

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AstraZeneca has decided not to proceed with regulatory filings for fostamatinib, the first oral spleen tyrosine kinase inhibitor being developed to treat rheumatoid arthritis, based on phase 3 trial results, according to a press release.

The rights to fostamatinib will be returned to Rigel Pharmaceuticals, AstraZeneca announced in the release.

“The results of the late stage trials did not measure up to the promising results we saw earlier in development,” Briggs Morrison, MD, executive vice president of global medicines development and chief executive officer at AstraZeneca, said. “We remain committed to new treatments for patients with rheumatic and inflammatory diseases with phase 2 compounds in rheumatoid arthritis and lupus and phase 3 compounds in gout and psoriasis.”

The results of AstraZeneca’s development efforts with fostamatinib will be reviewed by Rigel, according to a Rigel press release.

“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,” James M. Gower, Rigel chairman and chief executive officer, said.

Patients with rheumatoid arthritis (RA) who had inadequate response to disease-modifying antirheumatic drugs (DMARDs) participated in the OSKIRA-2 study. Fostamatinib, in combination with DMARDs, demonstrated a statistically significant ACR20 response rate at 24 weeks in the 100-mg, twice-daily group of patents and those receiving 100 mg twice daily for 4 weeks followed by 150 mg once daily (39.6%; P<.001, both groups), when compared with placebo patients (24.5%), according to AstraZeneca.

RA patients with inadequate response to methotrexate (MTX) and a single tumor necrosis factor-alpha antagonist participated in the OSKIRA-3 study. Fostamatinib with MTX displayed significant improvements in ACR20 response at 24 weeks with patients receiving 100 mg twice daily (36.2%; P=.004) but not in the group given 100 mg twice daily for 4 weeks followed by 150 mg once daily (27.8%; P=.168) compared with placebo (21.1%).

Safety and tolerability were generally consistent with previous studies. Commonly reported adverse events included hypertension, diarrhea, nausea, headache and nasopharyngitis.

AstraZeneca said it will incur a pre-tax impairment charge of approximately $140 million to research and development expense in the second quarter of 2013 for intangible assets relating to fostamatinib.