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Anthera Pharmaceuticals Reports 2010 Third Quarter Financial Results and Operational Update
Date:11/2/2010

llment, site qualification and start-up activities continued for the PEARL-SC Phase 2b study, which is examining the therapeutic benefit of A-623 in patients with systemic lupus erythematosus (lupus).  Enrollment has begun in the United States and, subsequent to the third quarter, sites in Colombia and Mexico were initiated and are enrolling patients. The study remains on track for a biomarker analysis in the first half of 2011.  The primary endpoint of the PEARL-SC study will be an SLE responder index.  Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01162681.
  • VISTA-16 site activations and patient enrollment are on schedule as of the end of the third quarter. Regulatory approvals and site initiations are ongoing in additional geographies. Stephen Nicholls, MD, John Kastelein, MD, and Greg Schwartz, MD, along with the Cleveland Clinic Coordinating Center for Clinical Research (C5), are providing executive oversight of the study.
  • Site monitoring and audits continue for the VISTA-16 study which is designed to reduce inflammation in high-risk patients following an ACS. Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01130246.
  • The Journal of the American College of Cardiology (JACC) published an article in September 2010 based upon the FRANCIS study, which is investigating the effects of varespladib methyl on cardiovascular biomarkers in ACS patients.
  • IMPACTS Phase 2 final study report is expected before the end of the year. Options for the next stage of development are under review and protocol is currently being finalized.

  • Manufacturing

  • The second manufacturing campaign of A-623 clinical material was completed and passed all quality assurance specifications.
  • The Company continues to make
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  • SOURCE Anthera Pharmaceuticals, Inc.
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    1. Anthera Announces Third Quarter 2010 Financial Report and Conference Call
    2. Anthera Pharmaceuticals Announces Pricing of $31.5 Million PIPE Financing
    3. Anthera Pharmaceuticals to Present at Deutsche Bank Securities 35th Annual Health Care Conference
    4. 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
    5. Antheras Varespladib Meets Primary Endpoint in Phase 2 FRANCIS Trial for the Treatment of Acute Coronary Syndrome
    6. Following Encouraging Results Anthera to Continue IMPACTS Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
    7. Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval
    8. Anthera Pharmaceuticals Advances Global Development Strategy for Varespladib in Patients With Acute Coronary Syndrome With the Initiation of FRANCIS Trial
    9. DSMB Supports Continuation of Anthera Phase II Impacts Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
    10. Anthera Enters Into Manufacturing Agreements for Varespladib in Preparation for Pivotal Phase III Trials
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