Hemispherx Biopharma has filed an amended NDA with ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica) for the use of Alferon N injection to treat Hepatitis C patients in Argentina.
ANMAT has previously approved the sale of Naturaferon in Argentina to treat recurring external condylomata acuminata (genital warts).
The company has filed the new NDA with ANMAT keeping in view the chronic hepatitis C patients who have become refractory to recombinant interferon as a result of the appearance of neutralizing antibodies (NABs) against recombinant interferon.
Hemispherx vice chairman Thomas Equels said Hepatitis C affects over 800,000 people in Argentina with a particularly high prevalence in rural communities.
Hemispherx Argentina marketing partner GP Pharm president Jorge Braverin said, "We are very excited about this opportunity to seek ANMAT approval of this additional indication for Alferon N Injection(R) in Argentina."
The company has also renewed its agreement with Armada Health Care, US, to supply Alferon N injection to physicians and patients through Armada's national network of pharmacies.
