PHILADELPHIA, Sept. 16, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company") today announced that its Board of Directors has just approved up to $4.4 Million (U.S.) for full engineering studies, capital improvements, system upgrades, and introduction of building management systems to enhance production of three products: Alferon N(R) (its FDA licensed biologic), Alferon LDO and Ampligen(R). Alferon LDO and Ampligen(R) (Poly I : Poly C12U) are experimental therapeutics being developed for multiple clinical indications including prevention, prophylaxis and treatment of both seasonal and pandemic influenza.
These investments will bring the capacity of the facility in alignment with the projected commercial supply forecast for both Alferon LDO(TM) and Ampligen(R) indications to serve markets for up to three years post approval. The facility upgrades are also consistent with the Company's long-term strategy to maintain control of key manufacturing steps of both Alferon LDO(TM) and Ampligen(R) while utilizing excess capacity available at contract manufacturing organizations for commodity "fill and finish" operations.
The Hemispherx manufacturing site located in New Brunswick, New Jersey, presently configured at over 43,000 square feet, will have capacity for Alferon LDO projected at 336 million doses per year based on the various facility improvements, which are expected to be underway immediately.
Details on utilization of the experimental therapeutics in ongoing and projected clinical trials will be presented at upcoming health care conferences.
About Hemispherx Biopharma
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 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.