Hemispherx Biopharma. Inc. has announced that it executed a renewed Sales, Marketing, Distribution and Supply Agreement for Argentina with GP Pharm Latino America (GP Pharm). The previous agreement had expired on June 14, 2015. Under this new agreement, GP Pharm will be responsible for gaining regulatory approval in Argentina for Ampligen®, an experimental therapeutic, to treat Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and for commercializing Ampligen® for this indication in Argentina.
The Company has granted GP Pharm expanded rights to sell this experimental therapeutic into other Latin American countries based upon GP Pharm achieving certain performance milestones. The Company has also granted GP Pharm an option to market Alferon N Injection® trademarked in Argentina as Naturaferon®, its FDA approved natural interferon, in Argentina and other Latin America countries. In 2012, under GP's original agreement they were able to extend Alferon's indication in Argentina to treat any disease that is refractory to Recombinant Interferon. Under this Agreement, the Company will manufacture and supply Ampligen® and Alferon® to GP Pharm.
Thomas K. Equels, Hemispherx CEO, said, "The renewal of the GP Pharm agreement is in anticipation of the upcoming ruling from ANMAT on our pending application for Ampligen's approval to treat CFS/ME. Since Hemispherx has no operation in Argentina it needs GP Pharm as its local representative in order for ANMAT to finalize its review and potentially provide Hemispherx an approval of Ampligen to treat CFS/ME patients in Argentina. Should we obtain this approval, we expect that it will also have a dramatic beneficial effect on our early access program partnerships which we have developed in Europe and Australia".
Jorge Braver of GP Pharm said, "Thousands of people suffer from ME/CFS, a particularly insidious disease for which there is no known cure, in Argentina and elsewhere in Latin America. We are looking forward to expanding our relationship with Hemispherx by undertaking the commercialization of Ampligen® in Latin America. 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 anti-viral capabilities, throughout Latin America."