Hemispherx and GP Pharm Agree to Establish a Manufacturing Operation in Argentina
to Serve Latin America Markets and Ancillary Markets
PHILADELPHIA - May 21, 2014 - 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.
Jorge Braver, CEO of GP Pharm, stated "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, stated "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."
About GP Pharm Argentina
GP Pharm SA International headquarters are located in Barcelona, Spain with operations in each major country in Latin America either directly or through local partners. Its activities are focused on research, development and marketing of injectable products made by partners and by GP Pharm SA based on its proprietary drug delivery systems which includes microspheres and liposomes. GP Pharm's new production plant recently achieved EU GMP approval and started manufacturing operations, producing the first batches of own products and also for some contract manufacturing partners. Its facilities are also designed to be FDA GMP compliant. GP Pharm also has a centralized free-zone distribution facility in Uruguay for its own products as well as its partners' products.