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Biopharmaceuticals Cardiology FDA

 News Release - January 4, 2007

Anthera Receives FDA Approval to Begin Phase 2 'PLASMA' Trial With A-002 for Patients With Coronary Atherosclerosis

SAN MATEO, Calif., Jan. 4 (HSMN NewsFeed) -- Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs for chronic and acute diseases, announced today that the US Food and Drug Administration has approved its Investigational New Drug (IND) application for its lead cardiovascular compound A-002. As a result of this approval, Anthera will initiate a multi-center phase 2 clinical trial (PLASMA -- Phospholipase Levels And Serological Markers of Atherosclerosis) that will examine the effect of A-002 on secretory phospholipase A2 (sPLA2) levels and other well established markers of inflammation and cardiovascular risk in patients with stable coronary artery disease due to underlying atherosclerosis. PLASMA is expected to complete enrollment by the fourth quarter of 2007.

sPLA2 is a family of enzymes that hydrolyze phospholipids leading to a chronic inflammatory response and harmful changes to serum lipid profiles. A-002 represents the first product in a class of compounds aimed at suppressing the activity of sPLA2. Recent animal data regarding A-002's impact on atherosclerosis, lipids, and inflammation will be presented at the 8th Congress on Inflammation in Copenhagen, Denmark, June 16th, 2007.

"The clinical burden of cardiovascular disease is large and will continue to grow over the coming decades. PLASMA is our first step on a path to provide a new option for patients who remain in need of more advanced therapies to treat their underlying vascular disease," stated Colin Hislop MD, Senior Vice President Clinical Development. "With increasing focus on chronic inflammation in patients with atherosclerosis, A-002 provides a potential new therapeutic approach to suppress inflammation, improve lipid profiles, and hopefully improve patient outcomes."

According to the American Heart Association, coronary heart disease affects nearly 14 million people in the United States and more than 30 million worldwide. Atherosclerosis is a disease of the arteries that results from inflammation and the build-up of plaque under the lining of the blood vessel. This build-up can cause vascular swelling and eventual rupture. sPLA2 levels have been shown to be elevated in patients with both stable and unstable coronary artery disease. Higher levels of the enzyme have been shown to predict an increased risk for future cardiovascular events such as heart attacks and stroke.

"PLASMA is intended to determine whether inhibition of sPLA2, an important trigger of the inflammatory response, can reduce systemic levels of inflammatory markers known to be predictors of coronary heart disease events. This study will serve as a basis for future trials that investigate the effects of sPLA2 inhibition on atherosclerosis progression and cardiovascular events," stated Robert S. Rosenson, M.D., Professor of Medicine and Director, Lipoprotein Disorders and Clinical Atherosclerosis Research, Division of Cardiovascular Medicine at the University of Michigan and the Principal Investigator for the PLASMA trial.

Further information about this clinical trial and atherosclerosis can be found at www.PLASMAtrial.com or www.anthera.com .

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a privately-held pharmaceutical development company committed to world-class development and commercialization of promising clinical products to address the unmet medical needs of patients with life-threatening chronic and acute inflammatory diseases. In 2006, Anthera acquired worldwide rights (except Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase (PLA2) family -- a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes‚ prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel‚ upstream steps in the inflammation cascade and have the potential to address a variety of diseases including: acute chest syndrome, acute lung injury, acute respiratory distress syndrome, atherosclerosis, Acute Coronary Syndrome, chronic obstructive pulmonary disease and psoriasis. In order to efficiently commercialize this platform, Anthera has brought together a proven management team with extensive experience in licensing, clinical research, development, and commercialization of anti-inflammatory products. For more information please visit www.anthera.com .


Source: Anthera Pharmaceuticals

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