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Anthera's Varespladib Meets Primary Endpoint in Phase 2 FRANCIS Trial for the Treatment of Acute Coronary Syndrome
Date:5/6/2009

- Favorable results for secondary endpoints support outcomes benefit

HAYWARD, Calif., May 6 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression), a clinical trial designed to examine the impact of 500mg of varespladib when administered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event, met its primary endpoint of a reduction in Low Density Lipoprotein Cholesterol (LDL-C). All patients in the FRANCIS trial received once daily doses of 80mg of Lipitor (atorvastatin calcium), plus 500mg of varespladib or matching placebo. Varespladib is a potent and highly selective oral inhibitor of secretory phospholipase A2 (sPLA2), an inflammatory enzyme implicated in ACS, vascular inflammation, atherosclerosis and adverse lipid profiles.

The pre-specified primary endpoint analysis was conducted when 500 patients reached at least eight weeks of treatment after an ACS event. In addition to meeting the primary endpoint, additional efficacy analyses at a variety of time points showed positive results for all clinically important secondary endpoints. The initial data review demonstrated:

- A statistically significant reduction in LDL-C at all prospectively defined time points and statistically significant reductions in total cholesterol and non-HDL cholesterol

- Varespladib's immediate and selective inhibition of sPLA2 effectively suppressed inflammation following the index event and was further evidenced by a statistically significant reduction in C-reactive protein.

- A statistically significant greater proportion of patients treated with varespladib achieved LDL-C levels of 70mg/dL or less (a target established by the American Treatment Program III for high-r
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SOURCE Anthera Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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