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Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval
Date:9/24/2008

f clinical data at the European Society of Cardiologists by GlaxoSmithKline on the effect of their selective Lp-PLA2 (lipoprotein-associated phospholipase A2) inhibitor, darapladib, on a secondary biological outcome while having no effect on inflammation or LDL-C, provides encouraging validation of the anatomical importance of reducing PLA2 activity in a cardiovascular population," said Dr. Robert S. Rosenson, Director of Lipoprotein Disorders and Clinical Atherosclerosis Research at the University of Michigan. "The on-going FRANCIS trial with varespladib, which is designed to evaluate and repeat the results of previous clinical data from PLASMA and PLASMA2 in an ACS population, should provide additional data on an already validated predictor of cardiovascular risk (LDL-C) coupled with reductions in PLA2."

In previous clinical trials, varespladib, a potent and highly selective inhibitor of secretory phospholipase A2 (sPLA2), has demonstrated marked improvements in independent markers of cardiovascular risk including, a near complete suppression of the target enzyme sPLA2, clinically meaningful and statistically significant reductions in "bad" LDL cholesterol, and a reduction in C-reactive protein, a known marker of inflammation.

Presently, the company is conducting the five hundred patient FRANCIS trial (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression) to assess the impact of oral varespladib on known biological markers of cardiovascular risk in ACS patients with elevated LDL and CRP. FRANCIS will also provide insight into the prevention of secondary Major Adverse Cardiovascular Events (MACE) over the duration of the six-month trial.

About Acute Coronary Syndrome

Acute coronary syndrome is a heart condition characterized by chest pain occurring at rest or upon minimal exertion. This condition is also referred to as unstable angina. If the chest pain is associated with heart muscle damage and he
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SOURCE Anthera Pharmaceuticals
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1. Anthera Pharmaceuticals Advances Global Development Strategy for Varespladib in Patients With Acute Coronary Syndrome With the Initiation of FRANCIS Trial
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3. Anthera Enters Into Manufacturing Agreements for Varespladib in Preparation for Pivotal Phase III Trials
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