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Anthera's A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
Date:12/18/2007

SAN MATEO, Calif., Dec. 18 /PRNewswire/ -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Product Development has granted A-001 orphan drug status for the prevention of acute chest syndrome in patients with sickle cell disease.

A-001 is currently being evaluated for acute chest syndrome in a Phase II clinical trial in the United States called IMPACTS (Investigation of the Modulation of Phospholipase in Acute ChesT Syndrome). In addition to orphan drug designation, the FDA has granted Anthera expanded enrollment of the IMPACTS trial to patients as young as five years of age.

"The orphan drug designation signifies an important milestone for Anthera in the development of A-001," stated James E. Pennington, M.D., Executive Vice President and Chief Medical Officer at Anthera Pharmaceuticals, Inc. "Orphan drug designation, in addition to our recent fast track designation from the FDA, further strengthens our development program and allows us to accelerate our efforts to develop a new treatment for this devastating condition, for which there is no cure."

About Acute Chest Syndrome

Acute Chest Syndrome (ACS) primarily affects children suffering from sickle cell disease. It is believed that the incidence of sickle cell disease is highest in children two to four years of age decreasing gradually to its lowest value in adults. Patients five to eleven are also a large part of the population who could benefit from a new therapy. ACS is also believed to be a contributor to pulmonary function abnormalities, pulmonary hypertension, and long-term mortality.

About the IMPACTS trial

The IMPACTS trial began recruiting patients in January 2007 and is a double-blind, randomized, parallel group, placebo-controlled dose escalation study aimed at preventing a severe respiratory complication of sickle
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SOURCE Anthera Pharmaceuticals, Inc.
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