Hemispherx Biopharma, Inc. 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.

Thomas Equels, executive vice chairman of Hemispherx, stated “We are confident about the potential opportunities for Alferon N Injection in Argentina and pleased with the progress GP Pharm is making evidenced by the recent regulatory submission.”

Dr Jorge Candal, medical director of GP Pharm said, “We are confident that the regulatory agency will understand the effectiveness of the unique technology platform represented by Alferon N Injection. We believe it can make a significant health impact in the lives of numerous patients in Argentina.”

Hemispherx continues to undertake its approximately $ 4.4 million expansion to its Good Manufacturing Process (GMP) manufacturing facility in New Brunswick, New Jersey regarding capital improvements, system upgrades and the introduction of a building management system to enhance production of its three products: Alferon N Injection, Alferon LDO and Ampligen. One of the primary goals for these enhancements to its FDA licensed facility is to accommodate larger production volumes of Alferon N Injection.

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 its injectable products made by others and by GP Pharm SA based on its proprietary drug delivery systems including microspheres and liposomes.

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.