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news.Hemispherx Biopharma has announced the preliminary stage agreement required to manufacture Ampligen in Argentina in order to serve Latin American markets should Ampligen be approved in Argentina.
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The aforementioned agreement is another important step moving forward in Argentina and South America pursuant to the company’s sales, marketing, distribution and supply agreement for Ampligen with GP Pharm.
The agreement is a prerequisite to the company starting the manufacture of stability lots, followed by stability testing, necessary to gain ANMAT’s approval to manufacture Ampligen, contingent upon ANMAT approval. The parties are also actively discussing establishing a manufacturing capacity for Alferon N in Argentina.
In June 2010, the parties entered into a sales, marketing, distribution and supply agreement for Ampligen in certain Latin American countries. In December 2010, the parties extended this agreement to cover Mexico.
In August 2012, the parties announced they had filed for approval of Ampligen by Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) to treat chronic fatigue syndrome (CFS). This application is pending and there can be no guarantee that Ampligen will be approved in Argentina or in any other country.
In December 2010, the parties entered into a sales, marketing, distribution, and supply agreement with respect to Hemispherx’s natural interferon, Alferon N, the only FDA approved natural interferon for the treatment of refractory HPV genital warts.
In August 2011, the parties announced they had filed for approval by ANMAT of Alferon N for treatment of this condition. In January 2012, ANMAT approved Alferon N for this indication. In October 2012, the parties announced they had applied to ANMAT for an extended treatment indication for Alferon N.
This approval, for any patient nonresponsive to recombinant interferon, was thereafter approved by ANMAT in March 2013, significantly broadening the Alferon N label of approved treatments.
GP Pharm CEO Jorge Braver noted that this agreement is important for an Argentinian pharmaceutical company because it establishes the potential to manufacture products which originate outside Argentina.
"This agreement has the potential to create jobs in Argentina and import technology and expertise in the pharmaceutical and biopharmaceutical fields and will expand our presence, over time, in new South American markets pending approval," Braver added.