) and its partner
) recently announced top-line data from the phase IIb OSKIRA-4
study evaluating the use of oral fostamatinib for rheumatoid
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The OSKIRA (Oral Syk Inhibition in Rheumatoid Arthritis)-4 study
evaluated fostamatinib as a monotherapy in patients who had never
been prescribed a disease-modifying anti-rheumatic drug (DMARD),
or are intolerant or show insufficient response to DMARDs. The
study enrolled 280 patients with primary objectives to establish
superiority of fostamatinib against placebo at 6 weeks and
non-inferiority in comparison to
) Humira (adalimumab) at 24 weeks.
In the six-month study, fostamatinib was evaluated in three dose
regimens (100mg twice daily for 4 weeks followed by 100mg twice
daily, 150mg once daily and 100mg once daily for the rest of the
Fostamatinib demonstrated superiority over placebo at two
regimens but failed to do so at 100mg twice daily followed by
100mg once daily. The candidate failed to show non-inferiority to
Humira at all dose regimes.
With the candidate failing to show non-inferiority to Humira,
investors have reacted negatively and the share price of
AstraZeneca and Rigel Pharma plunged 2.9% and 34.6%,
The pivotal phase III OSKIRA program is ongoing, results from
which are expected in the first half of 2013. AstraZeneca plans
to submit marketing application in the second half of 2013.
We note that competition is tough in the RA market, with players
Johnson & Johnson
) and Abbott Labs. Competition increased with the approval of an
oral RA treatment,
) Xeljanz in November 2012.
Neutral on AstraZeneca
We are encouraged by the company's focus on high-potential
emerging markets and are pleased with its effort to drive the
bottom line through cost-cutting initiatives and share buybacks.
However, we remain concerned about the generic competition faced
by the company's key products. In 2011, the company lost revenues
worth almost $2 billion to generic competition. The weak
late-stage pipeline coupled with the slow Brilinta uptake also
Currently, we have a Neutral stance on AstraZeneca in the long
run. The stock carries a Zacks #3 Rank (Hold) in the short run.
Large-cap pharma stocks currently holding a Zacks #2 Rank include
), Johnson & Johnson and