PHILADELPHIA, Dec. 13, 2007 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) today announced that it has concluded an agreement with a major vaccine manufacturer in Japan for the use of the Company's experimental drug Ampligen(r) as an immune enhancer to influenza vaccines. The Company's agreement with BIKEN (the non-profit operational arm of the Foundation for Microbial Diseases of Osaka University) is part of a 3 party agreement to develop an effective influenza vaccine for Japan and utilizes vast resources of the National Institute of Infectious Diseases of Japan ("NIID").
BIKEN has been developing and producing vaccines since 1952 and produces approximately 4% of the world's vaccine supplies, including vaccines that are FDA-licensed for use in the United States for acellular pertussis, Japanese encephalitis and the Oka strain of varicella. BIKEN's pharmaceuticals have been distributed by Sanofi-Pasteur, GlaxoSmithKline and Merck.
BIKEN, which owns intellectual property rights related to candidate novel influenza vaccines, is evaluating the functional capability of Ampligen(r), an experimental drug as a vaccine enhancer as part of a research project titled, "Research Project on Clinical Application of the Influenza Virus in the Intranasal Dosage Form for Mucosal Administration." BIKEN will immediately purchase supplies of Ampligen(r) from Hemispherx to conduct further animal models of intranasal prototype vaccines containing antigens from the influenza sub-types H1N1, H3N2 and B, progressing to human studies with all programs supported by the Japanese Health Ministry.
"We are pleased to extend and deepen our work with NIID-associated researchers toward combating prevalent and deadly influenza strains," commented Hemispherx Biopharma's CEO and Chairman, William A. Carter, M.D. "We have observed that resistance to standard antivirals has increased from 1% in 1994 to 91% in 2005, underlining the importance of strengthening and enhancing cross-protection against viruses that already kill thousands each year, and threaten to breakout into a global pandemic."
Hemispherx stated that its selection of BIKEN as a key avian and seasonal flu vaccine partner for Japan was the culmination of a search which included identification of: a) research excellence; b) outstanding historical safety record in vaccine production; c) historically excellent compliance record with regulatory authorities worldwide and d) robust collaborative agreements with NIID to provide accelerated, independently verifiable, results by internationally recognized government researchers.
Under terms of the non-exclusive licensing arrangement, Hemispherx will receive both royalties as well as income for all Ampligen(r) supplies used in both the ongoing experimental work and any subsequent marketing of Ampligen(r) as an immunoenhancer for flu vaccines delivered intranasally in Japan. Additional rights accruing to Hemispherx from the 3 party agreements including NIID allow exclusive conveyance of all intellectual property rights on Ampligen(r) as an immunoenhancer, thus buttressing the company's growing global patent estate.
To date, only 2 or 3 pharma companies worldwide have achieved regulatory authorizations to sell intranasally (IN) administered influenza vaccines versus many companies receiving approval for intramuscular vaccine delivery routes. Safety has been paramount in developing effective treatments. However, animal studies to date indicate Ampligen(r), an experimental drug, may be safely administered intranasally. Clinical studies (in other disorders) have built a database of more than 90,000 injections of Ampligen(r) when given parenterally (intravenous, or "IV").
In animal work to date conducted by NIID, Ampligen(r) IN co-administration with vaccine caused the robust elaboration of Ig A (immuno globulin), a unique protective substance. For example, Ig A secretion in many animal species historically can convey life long protection from a single dosage with no apparent requirement for "boosting" periodically as most vaccines require for multiyear protection. Recent articles on Ampligen(r) IN delivery/H5N1 can be sourced at the Institute Pasteur publication Microbes and Infection vol. 9 pp 1333-1340, 2007 and Journal of Infectious Disease, Nov. 1, 2007, p. 196.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced biopharmaceutical 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 100 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 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. 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.