Hemispherx signs with GP Pharm to manufacture Ampligen in Argentina

By Zachary Brennan

- Last updated on GMT

Hemispherx Biopharma announced a preliminary stage agreement with GP Pharm to manufacture Ampligen in Argentina in order to serve Latin American markets pending approval. 

The agreement is a prerequisite to the company starting the manufacture of stability lots, followed by stability testing, which are necessary to gain approval to manufacture Ampligen in Argentina. The companies are also actively discussing establishing manufacturing capacity for Alferon N in Argentina, which is the only US FDA-approved treatment of refractory HPV genital warts.

Jorge Braver, CEO of GP Pharm, said, “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​.”
In June 2010, Hemispherx and GP Pharm entered into a sales, marketing, distribution and supply agreement for Apligen in Latin American markets, which was subsequently extended to cover Mexico. The companies in August 2012 announced they had filed for approval of Ampligen to treat Chronic Fatigue Syndrome. 
Thomas Equels, executive vice chairman of Hemispherx, added, “We see this as a logical expansion of our relationship with GP Pharm in Latin America which also provides Hemispherx with backup manufacturing as well as a means for making and supplying products to Latin America. This is an excellent synergy of the assets of both companies​.”

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