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Hemispherx And GP Pharm Agree To Establish A Manufacturing Operation In Argentina To Serve Latin America Markets And Ancillary Markets

Stocks in this article: HEB

PHILADELPHIA, May 21, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced the preliminary stage agreement required to manufacture Ampligen® in Argentina in order to serve Latin American markets should Ampligen® be approved in Argentina. The aforementioned agreement is another important step moving forward in Argentina and South America pursuant to our 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 Administración Nacional de Medicamentos, Alimentos y Tecnología Médica ("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.

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