Hemispherx BioPharma (NYSE MKT:HEB) has said that ANMAT, the agency responsible for the regulation of drugs, foods and medical technology in Argentina, has approved the use of its Alferon N injection in the country for any patient that fails or becomes intolerant to treatment with "recombinant interferon" - expanding the indication for the drug widely.
Alferon N Injection is an FDA-approved natural interferon and, as Naturaferon, was already previously approved in Argentina for the treatment of refractory or recurring external genital warts - one of the main culprits of cervical cancer.
The timelines for when the drug, which can now also be used for multiple sclerosis, certain cancers and hepatitis C, can be shipped to Argentina, and when resulting revenues will occur cannot be determined at this time, the company has said.
According to the statement, patients on recombinant interferon can become intolerant to treatment with the side effects outweighing the benefits of the therapy, as well as also potentially developing antibodies that render the drug ineffective.
In a peer reviewed article, Hemispherx provided an analysis of its treatment and the clinical impact of neutralizing antibodies, across a wide range of human diseases. It found that across all the different diseases the authors reviewed, 33 of 40, or 82 percent, of these patients had their clinical response restored after switching to natural interferon.
"Hepatitis C affects over 800,000 people in Argentina and while the prevalence of multiple sclerosis there is much lower it can be severely debilitating, particularly in patients with a high rate of relapse," said executive vice chairman of the company, Thomas Equels.
"We view this progress in Argentina as continued demonstration of our efforts to expand the market for Alferon N Injection both geographically and by indication."
Hemispherx said in its statement that both the use of its existing inventory of Alferon N Injection for sale in Argentina as well as the use of drug to be manufactured in the future when its Alferon manufacturing facility in New Brunswick is completed, will require FDA approval.
The company's partner in Argentina, GP Pharm, cited president Jorge Braver as saying that he believes this expanded labeling for the treatment will also result in expanded insurance coverage for patients.
"We are very pleased that the ANMAT approved the expansion of the labeling for Naturaferon. Now patients in Argentina with hepatitis C, multiple sclerosis, certain cancers and other diseases who should not be treated with recombinant interferon, including pegylated alpha interferons, will have access to our therapy," Braver said.
"In many cases, these patients would have had no alternative."
Hemispherx is also working on the FDA approval for its Amligen drug for chronic fatigue syndrome (CFS), after the regulatory agency declined approval last month. In the complete response letter, the FDA said the company should conduct at least one additional clinical trial and complete various non-clinical studies, as well as perform a number of data analyses.
The company has said it plans to request an end-of-review conference with the FDA to discuss the agency's decision regarding this potential treatment. The drug, which is a 30-minute infusion into the bloodstream, works by stimulating the immune system through a receptor called TLR-3.
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