Hemispherx Biopharma, Inc. has entered a preliminary agreement with GP Pharm for the manufacture of Ampligen in Argentina to serve Latin American markets upon approval. The agreement is a prerequisite to the company starting the manufacture of stability lots and stability testing necessary for approval to manufacture Ampligen, contingent upon ANMAT approval in Mexico.
In June 2010, the companies entered into a sales, marketing, distribution and supply agreement for Ampligen in certain Latin American countries, which was extended in December 2010 to include Mexico, where the drug was filed for approval in August 2012 to treat Chronic Fatigue Syndrome.
The compnaies are also discussing establishing manufacturing capacity for Hemispherx's natural interferon, Alferon N, the only FDA approved natural interferon for the treatment of refractory HPV genital warts. The drug has also been approved in Mexico for this indication.
Jorge Braver, chief executive officer 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."
Thomas Equels, executive vice chairman of Hemispherx, said, "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."