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Anthera Pharmaceuticals Reports 2011 Fourth Quarter Financial Results and Provides Clinical Progress Update
Date:2/21/2012

DSMB) met for the fifth time to review the available safety data and recommended the study continue without change.  VISTA-16 is a Phase 3 pivotal clinical study evaluating the benefit of early varespladib treatment in high-risk ACS patients.  As per a Special Protocol Assessment with FDA, the primary endpoint of the VISTA-16 study is a reduction in Major Adverse Cardiovascular Events (MACE) as defined by FDA draft guidance to include cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or documented unstable angina with objective evidence of ischemia requiring hospitalization.  Details regarding the study can be found at http://www.clinicaltrials.gov.
  • In the fourth quarter of 2011, the VISTA-16 study accrued the requisite one hundred and ninety-three (193) adjudicated primary endpoint events required for the pre-specified interim efficacy analysis.  Subsequent to the end of the fourth quarter, the DSMB scheduled a meeting for the second week in March 2012 to review all available safety data and to conduct the formal interim efficacy analysis.  The interim efficacy analysis plan for the VISTA-16 clinical study allows for a recommendation by the DSMB to stop the study should there be sufficient evidence of overwhelming treatment benefit in the varespladib arm after approximately 193 of the primary events have been accrued.  Overwhelming benefit is defined as a treatment effect in favor of the varespladib arm resulting in a p-value of less than 0.001 (p<0.001).
  • Enrollment in the Phase 2b PEARL-SC clinical study was completed (N=547) in the fourth quarter. The PEARL-SC study is examining the therapeutic benefit of monthly and weekly subcutaneous doses of blisibimod in patients with lupus.  The primary endpoint of PEARL-SC requires patients to demonstrate a greater than or equal to five (>/=5) point reduction in the SELENA-SLEDAI clinical assessment s
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  • SOURCE Anthera Pharmaceuticals, Inc.
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    1. Anthera Announces Completion of Enrollment and Dosing in Phase II Trial of A-002 for the Treatment of Cardiovascular Disease
    2. Anthera Announces Positive Phase II Clinical Results From A-002 Cardiovascular Disease Trial
    3. Antheras A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
    4. Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular Trial
    5. Anthera Enters Into Manufacturing Agreements for Varespladib in Preparation for Pivotal Phase III Trials
    6. DSMB Supports Continuation of Anthera Phase II Impacts Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
    7. Anthera Pharmaceuticals Advances Global Development Strategy for Varespladib in Patients With Acute Coronary Syndrome With the Initiation of FRANCIS Trial
    8. Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval
    9. Following Encouraging Results Anthera to Continue IMPACTS Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
    10. Antheras Varespladib Meets Primary Endpoint in Phase 2 FRANCIS Trial for the Treatment of Acute Coronary Syndrome
    11. Anthera Pharmaceuticals Announces Agreement With the FDA on a SPA for Planned Phase 3 Varespladib A-002 Study; Daniel K. Spiegelman Joins Board of Directors
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