) announced top-line data from the phase III study (OSKIRA-1: n =
923) on its rheumatoid arthritis (RA) candidate fostamatinib. The
study assessed the safety and efficacy of the candidate for a
period of 24 weeks.
The study 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 combination with methotrexate versus
methotrexate along with placebo.
The study revealed mixed results on fostamatinib. While
fostamatinib demonstrated significant improvement in the signs
and symptoms of RA, measured using American College of
Rheumatology (ACR) 20 response rates, it did not show a
statistically significant difference in modified total sharp
Data from two other studies on fostamatinib, OSKIRA-2 and
OSKIRA-3, are expected in the second quarter of 2013. We note
that AstraZeneca licensed the candidate from
Rigel Pharmaceuticals, Inc.
) in Feb 2010.
Last month AstraZeneca initiated a major overhaul of its R&D
and selling, general and administrative (SG&A) segments. As
per the proposed plans, the company's R&D activities will be
primarily centered in three facilities including UK (Cambridge),
US (Gaithersburg) and Sweden (Mölndal).
The proposed initiative will result in relocation and
termination of approximately 2,500 and 1,600 roles, respectively,
in the 2013-2016 timeframe and cost approximately $1.4 billion.
The SG&A segment will also be optimized with the help of
restructuring activities, which will result in the termination of
approximately 2,300 employees.
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