Hemispherx BioPharma (HEB)

[TOUCAN]

Hemispherx Biopharma Receives Favorable Notice Via Its Subcontractor That the FDA Seattle District Accepts Ampligen(R) Manufacturing Response:

PHILADELPHIA, Feb. 2, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the â??Companyâ?), announced that the Company, via its manufacturing subcontractor, received a favorable response from the Food and Drug Administration (â??FDAâ?) Seattle District Office (â??DOâ?) related to the latest response to  the Prior Approval Inspection submitted on Dec.11, 2009, and noted in Hemispherxâ?? press release on Dec.16, 2009. The DO has accepted that certain manufacturing issues noted in the pre-approval inspection at the facility have been fully addressed and has made a recommendation for manufacturing approval with the Companyâ??s subcontractor listed as a manufacturing site to the FDA Office of Compliance in Washington, DC.  The referenced response on Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic being developed for potential treatment of Chronic Fatigue Syndrome (â??CFSâ?), is the combined work-product of the staffs at Hemispherx and its subcontractor. These favorably resolved manufacturing issues are the same ones sited in the Complete Response Letter from the FDA described in Hemispherxâ?? December 1, 2009 press release. The DO recommendations are not binding on the FDA and pertain only to the specific manufacturing issues cited in the Ampligen® manufacturing response.



About Hemispherx Biopharma



Chronic Fatigue Syndrome is an enigmatic, profoundly debilitating and potentially life-threatening disease with which a new retrovirus was recently associated. Researchers are investigating the possible role of this virus in the symptomatology of the disease using Ampligen® as an investigational therapeutic.



Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherxâ??s flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® Oragens®, and Alferon LDO. Ampligen® and Oragens® represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherxâ??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 50 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit http://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 Companyâ??s filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen®, 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. There is no assurance that Hemispherx will receive regulatory approval from the FDA for the commercial manufacture and distribution of Ampligen® or any other investigational drug. The forward-looking statements represent the Companyâ??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® do not imply that the product will ever be specifically approved commercially for these other treatment indications.

LINK:
http://finance.yahoo.com/news/Hemispherx-Biopharma-Receives-pz-3778983056.html?x=0&.v=1