PHILADELPHIA, Dec. 9, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") announced that the Company has amended its June 15, 2010 agreement with GP Pharm Latinoamerica ("GP Pharm"), an affiliate company of Spanish GP Pharm SA (www.gp-pharm.com) to immediately include Mexico in the Territory under the Sales, Marketing, Distribution and Supply Agreement. Under this Agreement, GP Pharm Mexico will be responsible for gaining regulatory approval in Mexico for Ampligen®, an experimental therapeutic, to treat Chronic Fatigue Syndrome ("CFS") in Mexico and for commercializing Ampligen® for this indication in Mexico. The Company has granted GP Pharm the right to expand rights to sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance milestones.
Thomas Kenwood Equels, Executive Vice Chairman of Hemispherx and the leader of its world-wide marketing efforts, stated, "We are very pleased by the diligent efforts of GP Pharm in Argentina and encouraged that GP Pharm Mexico is prepared to undertake efforts immediately to gain approval and commercialize Ampligen for CFS in Mexico. I continue to believe this relationship will eventually lead to opening large markets for Hemispherx's platform technologies in Latin America."
Mr. Braver of GP Pharm said, "Our management at GP Pharm Mexico, an operation we established earlier this year, have learned that there are over 500,000 cases of Chronic Fatigue Syndrome in Mexico and, as with other CFS sufferers around the globe, these people have no effective treatment for this debilitating disease. We are pleased by the expansion of our relationship with Hemispherx and are committed to the broad commercialization of Ampligen® in Latin America."
About GP Pharm
GP Pharm SA headquarters are located in Barcelona, Spain with operations in each major country in Latin America either directly or through local partners. Its activities are focused on research, development and marketing of injectable products made by others and by GP Pharm SA based on its proprietary drug delivery systems including microspheres and liposomes. GP Pharm's new production plant recently achieved EU GMP approval and started manufacturing operations, producing the first batches of its own products and also for some contract manufacturing partners. Its facilities are also designed to be FDA GMP compliant. GP Pharm also has a centralized free-zone distribution facility in Uruguay for its own products as well as its partners' products.
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® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid 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 an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). 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® and Alferon® LDO) 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® do not imply that the product will ever be specifically approved commercially for these other treatment indications.