PHILADELPHIA, Dec. 20, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") announced that the Company has entered into an agreement with GP Pharm Latinoamerica ("GP Pharm"), an affiliate company of Spanish GP Pharm SA (www.gp-pharm.com) for the marketing of Alferon N Injection®, the Company's natural interferon injection product which has been FDA approved for a category of sexually transmitted diseases in Argentina with an option for other Latin American countries upon receipt of those respective countries' regulatory approval for any use of the product. Under this Agreement, the Company will manufacture and supply Alferon N Injection® to GP Pharm in Argentina under an exclusive Sales, Marketing, Distribution and Supply Agreement. Under this Agreement, GP Pharm will be responsible for gaining regulatory approval for each indication and commercializing Alferon N Injection® in Argentina. The Company has granted GP Pharm the right to expand its territory to include other Latin American countries based upon GP Pharm achieving regulatory approval and certain first sale performance milestones.
Thomas Kenwood Equels, Executive Vice Chairman of Hemispherx and the leader of its world-wide marketing efforts, stated, "I am very pleased that we have broadened our relationship with GP Pharm to include Alferon N Injection®."
Mr. Braver of GP Pharm said, "We are also excited to have the opportunity to market the FDA approved product, Alferon N Injection®, a natural interferon with a proven track record of safety and historically demonstrated exceptional anti-viral capabilities, in Argentina and potentially throughout Latin America."
In June of 2010, the Company and GP Pharm entered into a similar Sales, Marketing, Distribution and Supply Agreement for regulatory approval and sale of Ampligen®, an experimental therapeutic, to treat Chronic Fatigue Syndrome ("CFS") for Argentina including the right to expand rights to sell this experimental therapeutic into other Latin American countries based upon GP Pharm's achieving regulatory approval and certain first sale performance milestones.
About GP Pharm Argentina
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 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. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications.