PHILADELPHIA, July 14, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) today announced that all outstanding legal issues between Hemispherx and Bioclones (Proprietary), Ltd. and Ribotech (Pty) Ltd have been resolved and that all litigation between the companies is in the process of being dismissed by mutual agreement. Additionally, based on current discussions, Hemispherx management sees the potential for a mutually beneficial new Ampligen(r) partnership with the principals now controlling Bioclones and Ribotech.
As part of the settlement announced today, Hemispherx has regained all marketing rights to Ampligen(r) which had been previously granted to Bioclones for Great Britain, the Republic of Ireland, Australia, New Zealand, Tasmania, Madagascar, Mauritius, Reunion, Indonesia, Papua New Guinea and all nations on the continents of Africa and South America.
In October 1994, Hemispherx entered into a licensing and marketing agreement with Bioclones, a South Africa-based biopharmaceutical company, with respect to co-development of various RNA drugs, including Hemispherx's lead investigational drug, Ampligen(r). Pursuant to the 1994 agreement a subsidiary, Ribotech (Pty) Ltd, was created for pharmaceutical manufacturing utilizing recombinant DNA technology. Subsequently, Hemispherx deemed the 1994 agreement void due to alleged failures of performance by Bioclones.
Subsequent actions in U.S. and foreign jurisdictions included a December 2004 multi-count complaint by Hemispherx naming Bioclones as part of a conspiratorial group seeking to illegally manipulate the Company's stock for purposes of bringing about a hostile takeover, as well as January, 2007 arbitration proceedings initiated by Bioclones in South Africa against Hemispherx to determine damages arising out of the termination of the marketing agreement between the two companies and an application in South Africa by Hemispherx for the dissolution of Ribotech. None of these actions resulted in judgments or the levying of damages against any of the parties. Under the settlement announced today, all damage claims have been waived by the parties.
In June, 2006, Sekunjalo, a major South Africa-based listed empowerment company, acquired the controlling interest in Bioclones. Hemispherx retains an approximate 9% equity position in Ribotech, which is engaged in pharmaceutical manufacturing utilizing recombinant DNA technology.
Ampligen(r)'s Commercial Status
In October, 2007, Hemispherx submitted a new drug application (NDA) with the United States Food & Drug Administration (FDA) for the potential use of Ampligen(r) to treat Chronic Fatigue Syndrome. The FDA formally deemed the NDA application complete for substantive review on July 7, 2008.
"We are pleased with these timely results which put to rest past disputes with Bioclones and Ribotech and to regain marketing rights to Ampligen(r) for the potential treatment of CFS in the regions where we had previously granted those rights to Bioclones. We believe that the parties currently controlling Bioclones and Ribotech constitute potentially worthwhile regional partners for us," commented William A. Carter, M.D., Chairman and CEO of Hemispherx. "In fact, we are encouraged that our current discussions may result in a partnership focusing on Ampligen(r) as a potential adjuvant in future HIV vaccine clinical trials, especially in Africa, where HIV/AIDS has taken millions of lives and threatens many millions more. Settling old disputes with this emerging regional biotechnology leader fits well into our strategy to intensify exploration of Ampligen(r)'s potential to enhance the effectiveness of future HIV vaccine candidates."
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a 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) and Oragens(r). Ampligen(r) and Oragens(r) represent experimental RNA nucleic acids being developed for globally important debilitating diseases, including 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 90 issued 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 http://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(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.