PHILADELPHIA, Dec. 7, 2007 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced that it has received notice from the U.S. Food and Drug Administration (FDA) that its NDA submission for Ampligen(r) in Chronic Fatigue Syndrome (CFS), after preliminary review, had been determined to be insufficiently complete to permit a substantive review under 21 CFR 314.101 (d). Specifically eleven deficiencies were noted in the Clinical Section and three in the Pre-Clinical Section. No deficiencies were cited in the Chemistry, Manufacturing and Controls Section (CMC).
Hemispherx believes several factors may influence the pace of the regulatory path: (1) Ampligen(r) (Poly I : Poly C12U) has a relatively long regulatory history (approximately twenty years) and regulatory guidelines suggest that longer clinical development histories may require more review; (2) Ampligen(r) is also the first drug of its class to apply for NDA review status; and (3) in some circumstances, clinical data reporting guidelines have changed since the initial studies on Ampligen(r), an experimental therapeutic, were executed in the late 1980s and early 1990s.
The Company will respond promptly in writing to all of the filing issues raised by the FDA and will request a guidance meeting to clarify any items outstanding.
In October, 2007, the Company's New Brunswick facility passed a biannual FDA inspection relating to its fully commercialized interferon product (Alferon N Injection(tm)) with no infractions or citations.
The Company will continue to move forward, as originally planned, with its regulatory filings in various countries outside the United States, while continuing its efforts to meet all the FDA requirements. The NDA filing rate does not affect ongoing vaccine enhancement programs with Ampligen(r), an experimental TLR3 agonist, or ongoing Treatment IND programs for CFS in the U.S.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(r) and the experimental therapeutics Ampligen(r), Alferon LDO and Oragens(r). Alferon N Injection(r) is approved for a category of STD infection, and Ampligen(r) and Oragens(r) represent a large portfolio of experimental RNA nucleic acids being developed for globally important viral diseases, severely debilitating disorders and biodefense applications. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 90 issued patents comprising its core intellectual property estate, a fully commercialized product (Alferon N Injection(r)) and a GMP certified manufacturing facility for its novel pharma products. The Company is actively engaged in further expansion of its intellectual property on a world wide basis to reflect the global distribution of the various disorders which its platform technology addresses. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(r), Alferon LDO and Oragens) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(r) do not imply that the product will ever be specifically approved commercially for these other treatment indications.