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FDA Advisory Committee Makes Recommendations On Ampligen (R) For Chronic Fatigue Syndrome

Stocks in this article: HEB

PHILADELPHIA, Dec. 21, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx") today announced the outcome of the meeting of the Arthritis Advisory Committee (the "AAC") of the U.S. Food and Drug Administration (the "FDA") on the New Drug Application ("NDA") for Ampligen ® for Chronic Fatigue Syndrome ("CFS").

On the question: "Considering the totality of the data, is there substantial evidence of efficacy for Ampligen for the treatment of patients with chronic fatigue syndrome (CFS)?," the AAC voted 9 no, 4 yes and 1 AAC member left the room and did not vote.

On the question: "Has the safety of Ampligen been adequately assessed and characterized for the treatment of chronic fatigue syndrome (CFS)?," the AAC voted 9 no, 4 yes and 1 AAC member left the room and did not vote.

On the question: "Is the safety profile of Ampligen adequate for approval for the treatment of CFS?," the AAC voted 8 yes, 5 no and 1 non-vote.

On the question: "Based on the information included in the briefing materials and presentations, has the applicant provided sufficient efficacy and safety data to support marketing of Ampligen for the treatment of CFS?," the AAC voted 8 no, 5 yes and 1 non-vote.

Hemispherx is committed to the Ampligen ® clinical development program and to bringing Ampligen ® to market to ease the suffering of those seriously afflicted with CFS. The Company will also continue to work closely with the FDA to support the review of this investigational compound. Hemispherx will seek to do everything necessary to confirm in a scientifically rigorous manner that Ampligen ® is a safe and effective treatment for CFS.

The AAC based its voting on a review of data from the Ampligen ®clinical development program included as part of the Company's NDA submission. This submission included data on nine studies conducted in patients with CFS, including two pivotal studies and seven supportive studies. The trials were designed to evaluate safety, tolerability and efficacy in the approximately 845 patients (589 unique subjects suffering from severely debilitating CFS) who received Ampligen ®. The majority of the AAC members expressed the view that an additional controlled clinical trial of Ampligen should be conducted prior to the FDA granting approval.

The Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review of the NDA is February 2, 2013. The FDA uses committees, like the AAC, to obtain independent expert advice on scientific, technical, and policy matters to assist in its mission to protect and promote public health. The FDA is not bound by the AAC's recommendation, but will consider their recommendation in its review.

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