Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA

PHILADELPHIA, Jan. 9, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. announced today that it has formally submitted to the United States Food & Drug Administration ("FDA") detailed responses to all of the 14 questions posed by the FDA concerning the Company's New Drug Application ("NDA") for Ampligen(r), an experimental therapeutic, to treat Chronic Fatigue Syndrome ("CFS"). Hemispherx received the questions from the FDA on December 5, 2007, at which point the application was deemed by the FDA as "not sufficiently complete" to permit substantive review under 21 CFR 314.101(R). Consequently, the FDA's consideration of the NDA was postponed, pending receipt of the Company's answers to the questions.

The FDA questions spanned a range of clinical and preclinical topics. With the exception of a topical product for skin cancer, no TLR type compounds have yet received full regulatory clearance. TLR is an acronym for pharma compounds which signal broad "host defense" responses against various pathogens and disease conditions. Poly I: poly C12U (Ampligen(r)), an experimental therapeutic, is the first in this class of RNA (nucleic acid) molecules now seeking commercialization.

A recent independent study enumerated three primary causes of early death in CFS populations at large (without administration of Ampligen(r)) that may be attributable to the disease: 1) cardiovascular events, 2) suicide and 3) untreatable life-threatening malignancies/tumors. In response to the FDA's questions, as well as within the body of its NDA, Hemispherx addresses how Ampligen(r), an experimental therapeutic, may address these and other high risk aspects of CFS.

Only regulatory agencies can determine whether any experimental therapeutic, including Poly I: Poly C12U (Ampligen(r)) is "safe and effective." At this time, Ampligen(r), an experimental therapeutic, is only available in specific clinical trial settings conducted under specific governmental authorizations. It has not been determined to be "safe and effective" by any governmental body. Ampligen(r) represents an entirely new class of RNA-based drug therapies. The Company's prompt response to the questions posed by the FDA was made possible by the broad-based team of clinical and scientific experts assembled during 2007, with experience in successful global development of NDAs for new molecular entities ("NMEs"), such as Ampligen(r).