The Argentinian regulatory authorities have approved the use of Hemispherx Biopharma's Naturaferon (Alferon N injection) for any patient that fails or becomes intolerant to treatment with recombinant interferon (IFN). Naturaferon is an FDA-approved natural IFN and is already approved in Argentina for the treatment of refractory or recurring external condylomata acuminata.
Now, patients in Argentina with hepatitis C, multiple sclerosis, certain cancers and other diseases who should not be treated with recombinant IFN, including pegylated IFN alpha, will have access to Hemispherx' therapy.
Both the use of the Hemispherx' existing inventory of Naturaferon for sale in Argentina, as well as the use of drug to be manufactured in the future when the company's Naturaferon manufacturing facility in New Brunswick, Canada, is completed will require FDA approval. Therefore, the timelines for when drug can be shipped to Argentina and when resulting revenues in Argentina will occur cannot be determined at this time.