Hemispherx Biopharma Submits for Regulatory Approval of Alferon(R) in Argentina

Hemispherx Biopharma, Inc. HEB today announced its authorized agent GP Pharm Argentina has submitted to the ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica) regulatory agency responsible for the national administration of drugs, foods and medical technology for the approval of Alferon N Injection® for sales and distribution in Argentina. In June 2010, Hemispherx agreed to provide GP Pharm an option to market Alferon N Injection®, its FDA approved natural interferon, in Argentina and other Latin America countries as well. It is planned to be marketed under the brand name Naturaferon®. Alferon N Injection® is approved in the US for the treatment of refractory genital warts and a major scale-up of Alferon N Injection® manufacturing is underway at Hemispherx's New Brunswick, NJ facility. According to the World Health Organization website on Human Papillomavirus (HPV), "Genital warts are very common and are highly infectious, and between 90% and 100% are caused by HPV genotypes 6 and 11. Although, they do not usually result in death, genital warts cause significant morbidity and entail substantial health care costs. Recurrence is common." Alferon N Injection® has been shown to be effective against refractory genital warts. Because Alferon N Injection® is developed directly from human leukocytes, patients have generally not been observed to develop antibodies in contrast to interferons (r-IFNs) developed by recombinant DNA technology. Application of r-IFNs may lead to antibodies against the r-IFN. The development of neutralizing antibodies usually indicates the loss of clinical efficacy.