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Ampligen® Maker Pursues South American ME/CFS ‘Market’ via Collaboration with Regional Pharma Co.

  [ 29 votes ]   [ Discuss This Article ] • June 21, 2010

Hemispherx Biopharma, Inc. ("Hemispherx") announced on Jun 15 that it had “executed an exclusive revenue sharing Sales, Marketing, Distribution and Supply Agreement for Argentina with GP Pharm Latinoamerica ("GP Pharm"), an affiliate company of Spanish GP Pharm SA (”

Under this agreement, “GP Pharm will be responsible for gaining regulatory approval in Argentina for Ampligen®, an experimental therapeutic, to treat Chronic Fatigue Syndrome (CFS) in Argentina and for commercializing Ampligen® for this indication in Argentina.

Hemispherx “has granted GP Pharm the right to expand rights to sell this experimental therapeutic into other Latin American countries based upon GP Pharm achieving certain performance milestones…  Under this Agreement, Hemispherx will manufacture and supply Ampligen® to GP Pharm”… which would undertake its commercialization in Latin America.

[Note: Hemispherx has been sponsoring clinical trials of Ampligen® for many years, in hopes of gaining FDA approval to market the experimental drug as an ME/CFS treatment in the US. Most recently, in December 2009, the FDA refused Hemispherx’s new drug application stating it had not yet provided “credible evidence of efficacy,” and an open label trial for patients with severely debilitating ME/CFS continues at the Hunter-Hopkins Center in Charlotte, North Carolina.]

Source: Hemispherx Biopharma news release Jun 15, 2010

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