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Rigel Will Resume Responsibility for Fostamatinib Program
Date:6/3/2013

SOUTH SAN FRANCISCO, Calif., June 4, 2013 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) and AstraZeneca AB (AZ) today announced the topline results from OSKIRA-2 and OSKIRA-3, the remaining pivotal Phase 3 clinical trials investigating fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development for rheumatoid arthritis (RA). 

In the OSKIRA-2 study of patients inadequately responding to disease modifying anti-rheumatic drugs (DMARDs), fostamatinib in combination with DMARDs showed statistically significant improvements in ACR20 response rates at 24 weeks in both the 100 mg twice daily (bid) group and the group receiving 100 mg bid for four weeks followed by 150 mg once daily (qd) compared to placebo.

In the OSKIRA-3 study of patients inadequately responding to methotrexate (MTX) and a single TNF-alpha antagonist, fostamatinib in combination with MTX showed statistically significant improvements in ACR20 response rates at 24 weeks in the 100 mg bid group, but not in the group given 100 mg bid for four weeks followed by 150 mg qd compared to placebo.

Fostamatinib ACR20 Scores  OSKIRA1

OSKIRA2

OSKIRA3100 mg bid

49%, p<0.001

39.6%, p<0.001

36.2%, p=0.004100 mg bid/150 mg qd

44%, p=0.006

39.6%, p<0.001

27.8%, p=0.168Placebo

34%

24.5%

21.1%Fostamatinib continues to be well tolerated by patients. The safety findings in both the OSKIRA-2 and OSKIRA-3 studies were generally consistent with those observed in the prior OSKIRA-1 study as well as the TASKi Phase 2 program.Based on the totality of the results of the OSKIRA Phase 3 program in patients with RA, AZ has decided that it will not proceed with regulatory filings and will return the rights to the compound to Rigel.

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SOURCE Rigel Pharmaceuticals, Inc.
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