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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

SAN MATEO, Calif., Sept. 24 /PRNewswire/ -- Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA's Special Protocol Assessment procedure. At the same time, the company received Scientific Advice from the European Medicines Agency (EMEA) on Anthera's European development strategy for varespladib. Guidance from both regulatory agencies regarding varespladib will be incorporated into Anthera's global registration program slated to start next year.

Anthera's Special Protocol Assessment supports a single, pivotal, Phase 3 trial evaluating varespladib, in combination with Lipitor(R) (atorvastatin) as first-line treatment within 96 hours of an ACS event. In the European Union, Anthera received Scientific Advice that supports a similar clinical development program and include the potential to also utilize varespladib as an adjunctive treatment in patients with stable coronary disease and elevated levels of LDL-C and total cholesterol.

"We are pleased that both agencies recognized the potential of varespladib's multiple therapeutic effects in patients with cardiovascular disease," said Paul Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. "The anti-inflammatory effect and safety profile seen in the varespladib trials to date are very exciting and highlight the opportunity to help patients with recent coronary events."

"The regulatory clarity in the United States and Europe reinforces our confidence that we can efficiently deliver a novel therapeutic for patients with ACS," said Dr. Ursula Fritsch, Vice-President Global Regulatory and Compliance. "With this regulatory feedback, we have a clearly defined and reasonable development path to deliver a first in class therapeutic for ACS patients and individuals with hypercholesterolemia."

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SOURCE Anthera Pharmaceuticals
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