|August 04, 2003
|HEMISPHERX BIOPHARMA RECEIVES NEW PATENTS FOR ORAL DOSED BROAD-SPECTRUM IMMUNE ACTIVATORS
|Company Prepares Applications to Bioterror and Emerging Infectious Diseases Granting Programs
Philadelphia, PA, Monday, August 04, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB), a leading company in the experimental-stage development of immune based therapies primarily addressing the diseases of Chronic Fatigue Syndrome, HIV/AIDS and HPV, announced today the receipt of major new patents in Europe on a set of orally active low molecular weight RNA compounds, trade marked “ORAGENS®”, which are designed to function within a broad spectrum of antiviral and immunological activities.
International Research Consortium: Government and Academic Researchers
Because of the unusual breath and scope of the application, nearly 14 years were required for successful prosecution and issuance of the patents. During the intervening years, important collaborations were created with U.S. and European Universities, especially those in Germany, as well as the National Institutes of Health (NIH). The results of these collaborations, published and/or pending applications in peer review journals, establish the therapeutic promise of these new experimental drug entities in various chronic diseases associated with immune dysfunction and chronic viral replication or viral “footprints”.
Possible Application to Bioterror, National Defense Program
Bioterror attacks may require initial strengthening of first line of immune defense while the attacking agent is being identified. Oragens® may serve such a role because of their unique mechanism of action on the dormant human immune system.
The intent of the patents is to offer a relative ease and convenience of oral dosing in chronic diseases where currently injection or infusion is the common method of drug introduction. Typically, oral applications dramatically broaden the use of drugs and increase patient compliance in both clinical trial and post approval use as compared with intravenous infusion or intramuscular injection.
Scope of Patents
The patents designated “Phosphorothioate/Phosphodiester Oligoadenylates and Antiviral Uses thereof” are being issued in 8 countries: Germany, France, United Kingdom, Spain, Switzerland, Ireland, Belgium and Luxembourg. Hemispherx’s European subsidiary, Hemispherx Biopharma Europe, announced last year a significant licensing and equity placement surrounding one of its lead high molecular weight RNA compounds, termed Ampligen®, which is in Phase 3 clinical trials and is a parentally injected product. Hemispherx is evaluating manufacturing worldwide to facilitate the potential scaling up of production of specific Oragens®.
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Its flagship products include Alferon and the experimental immunotherapeutics/antivirals Ampligen and Oragens. These novel proteins, approved for a category of STD infection, and experimental nucleic acids are being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS, Hepatitis and SARS. Its platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has approximately 400 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net.
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6223
HEB's Web Site: 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 AmpligenÒ and Oragensä) 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 AlferonÒ do not imply that the product will ever be specifically approved commercially for these other treatment indications including SARS. The Alferon® asset for overseas sales for a category of STD is currently being acquired by the Company as part of a multi-step purchase contract of inventory, intellectual property, commercial licenses and GMP approved facilities, which house the biological operations