PHILADELPHIA, Dec. 16, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), stated that on December 11, 2009, the Company, via its manufacturing subcontractor, in Spokane, WA, submitted comprehensive new data to the regional office of the Food and Drug Administration ("FDA"), Seattle, WA, which Hemispherx management believes demonstrate that certain manufacturing issues noted in earlier pre-approval inspections at the facility have been fully addressed. The referenced reports on Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic being developed for potential treatment of Chronic Fatigue Syndrome ("CFS"), are the combined work-product of the staffs at Hemispherx and its subcontractor. These are the same manufacturing issues sited in previous 10-Q's and the recent 10-K. These manufacturing issues were also part of a Complete Response Letter from the FDA described in a December 1, 2009 press release.
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(R) 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. Hemispherx's flagship products include Alferon N Injection(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. 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 50 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. 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 completion of the NDA filing process with Ampligen(R) and the receipt of a Complete Response Letter from the FDA do not imply that the Company will be able to successfully comply with any or all of the requirements requested in that Letter or that the product will ever be approved for commercial sale. In addition, 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(R) LDO and Oragens(R)) 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; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.