) recently announced its decision to return the rights to its
rheumatoid arthritis (RA) candidate, fostamatinib to
Rigel Pharmaceuticals, Inc.
). AstraZeneca took this decision based on mixed data from the
OSKIRA phase III program and will no longer pursue regulatory
filings for the candidate.
The OSKIRA phase III program comprised of three phase III
studies: OSKIRA-1 (n ~ 900), OSKIRA-2 (n ~ 900) and OSKIRA-3 (n ~
320). The studies evaluated two dosing regimens of fostamatinib,
100 mg twice daily and 100 mg twice daily for four weeks followed
by 150 mg once daily in RA patients who had responded
inadequately to currently approved therapies such as disease
modifying anti-rheumatic drugs (DMARDs) including methotrexate
(OSKIRA-1 and OSKIRA-2) and TNF-α antagonists (OSKIRA-3).
As per top-line results from OSKIRA-2, fostamatinib demonstrated
statistically significant improvement in the signs and symptoms
of RA, measured using American College of Rheumatology (ACR) 20
response rates, in combination with DMARDs versus placebo in both
In OSKIRA-3, while fostamatinib in combination with methotrexate
showed statistically significant improvement versus placebo, in
100 mg twice daily arm it failed to do so in the other.
In Apr 2013, mixed data from the OSKIRA-1 study was announced.
The study evaluated fostamatinib in combination with
methotrexate. While fostamatinib demonstrated significant
improvement in ACR 20 response rates, it did not show a
statistically significant difference in modified total sharp
In the phase III studies fostamatinib was found to be generally
safe and well tolerated. We remind investors that AstraZeneca was
collaborating with Rigel Pharma for the worldwide development and
commercialization of fostamatinib since Feb 2012.
AstraZeneca's pipeline is currently under severe pressure with
revenues plunging due to generic competition faced by several key
drugs including Seroquel. The company will face additional
pressure once Nexium (2014) and Crestor (2016) start facing
We note that this move does not affect AstraZeneca's 2013
guidance. AstraZeneca continues to expect 2013 revenue to decline
in the mid-to-high, single digit and core earnings to decline
considerably more than revenue.
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