PHILADELPHIA, March 16, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Alternext US:HEB) announced its financial results for the fiscal year ended December 31, 2008. The net loss for the year (including non-cash charges) was approximately $12,219,000 or $0.16 per share compared a net loss of $18,139,000 or $0.25 per share in 2007. This $5,920,000 reduction in loss was primarily due to: 1) $4,644,000 in lower research and development expenses with 2007 including significant costs related to the preparation of the Ampligen(r) New Drug Application ("NDA"); and 2) General and Administration expenses were lower by $2,496,000, as a result of a reduction program.
In 2008, the Company reported significant progress on its various technology platforms. The NDA for Ampligen(r) commercialization as a potential treatment of Chronic Fatigue Syndrome ("CFS") was accepted for review by the Food and Drug Administration ("FDA") in July 2008, and various discipline review letters, received from the Agency, were responded to by the Company in December, 2008 and January, 2009. On February 18, 2009, we were notified by the FDA that the originally scheduled Prescription Drug User Fee Act ("PDUFA") date of February 25, 2009, had been extended to May 25, 2009. Extensive preparations for the FDA inspections of the Company's New Brunswick, NJ Manufacturing Facility resulted in an inspection that identified only minor infractions that Management believes can be easily corrected. Clinical study audits by the FDA were also conducted across the country without identification of regulatory deficiencies. Biken Corp., a strategic partner, and the Japanese National Institute of Infectious Diseases, reported their accelerated animal program to utilize Ampligen(r) as an immunoenhancer in combination with various flu vaccines. The Company also completed enrollment of a Phase II flu prevention clinic study in Australia. In addition, several significant academic relationships, including those at Stanford University, University of Washington, National Institutes of Health and Harvard University were initiated to accelerate development of the Company's platform technologies in allied areas including cancer and other life threatening disorders.
During 2008, the Company initiated and successfully implemented cost reduction and containment programs to preserve cash while maintaining the resources necessary to achieve its primary commercial objectives, obtaining NDA approval of Ampligen(r) and securing various strategic partners for the potential marketing of Ampligen(r) as well as widening sales of its commercial product, Alferon N(tm). The services of the Sage Group, a health care consultant organization, were retained to assist in these various initiatives.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharma 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) and Oragens(r). 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.