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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

isk patients) and maintained this lower level throughout the primary endpoint. The effect was more pronounced for patients achieving LDL-C below 50 mg/dL.

"Building on strong results from our first two clinical studies in stable cardiovascular patients, the FRANCIS study has validated the potential utility of aggressive varespladib treatment to improve outcomes in a high-risk patient population immediately following an ACS event," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. "In addition to meeting the primary and several secondary endpoints, clinical data from the FRANCIS study has met and/or exceeded our expectations and we hope to present the entire data set including biomarkers, safety, and secondary clinical endpoints (MACE) at an upcoming scientific conference."

"We are extremely excited by these data," said Colin Hislop, M.D., Senior Vice President Clinical Development at Anthera. "The favorable treatment effect of varespladib is consistent with our Phase 3 development plan and provides a robust data set to support substantial clinical benefit for this novel, first in class therapy."

With approximately 1000 patient exposures to date in three cardiovascular studies, varespladib has been generally well tolerated.

About the FRANCIS trial

The FRANCIS trial is based upon direct feedback from Food and Drug Administration via the Special Protocol Assessment process. FRANCIS was designed to assess the impact of oral varespladib on known biological markers of cardiovascular risk. It enrolled 625 patients who will be treated for a minimum of six months. The study is being conducted at sites in Europe. FRANCIS is designed to provide insight into the potential prevention of secondary Major Adverse Cardiovascular Events (MACE) by varespladib. In this study, MACE was defined as a composite endpoint consisting of all-cause mortali
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SOURCE Anthera Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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2. Anthera Pharmaceuticals Advances Global Development Strategy for Varespladib in Patients With Acute Coronary Syndrome With the Initiation of FRANCIS Trial
3. Anthera Enters Into Manufacturing Agreements for Varespladib in Preparation for Pivotal Phase III Trials
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