Hemispherx Enters a Collaboration with Emerge Health for the Commercialization of Ampligen for Chronic Fatigue Syndrome (CFS) in Australia and New Zealand
Mar 09, 2015 08:30:00 (ET)
Hemispherx Enters a Collaboration with Emerge Health for the Commercialization of Ampligen for Chronic Fatigue Syndrome (CFS) in Australia and New Zealand
Hemispherx and Emerge Health to Commence Named Patient Sales While Seeking Formal Regulatory Approval
PHILADELPHIA, March 9, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), reported today that it has executed an agreement with Emerge Health Pty Ltd. ("Emerge") to seek approval of Ampligen, an experimental immunotherapeutic, for Chronic Fatigue Syndrome in Australia and New Zealand and to commence distribution of Ampligen in both countries on a named-patient basis, where deemed appropriate.
Hemispherx and Emerge will collaborate on seeking regulatory approval from Australia's Therapeutic Goods Administration ("TGA") and New Zealand's Medicines and Medical Devices Safety Authority ("Medsafe").
Under an exclusive license to sell, market, and distribute Ampligen in Australia and New Zealand to treat Chronic Fatigue Syndrome, Emerge will implement regulatory-compliant programs to educate physicians about Ampligen for CFS and seek orphan drug designation and approval of Ampligen to treat CFS. Hemispherx will support these efforts and will supply Ampligen at a predetermined transfer price.
Chris Rossidis, Co-Founder and COO of Emerge, said, "This agreement with Hemispherx represents an opportunity which is exactly why Emerge was formed, to provide Australian and New Zealand patients with products that their physicians believe would be helpful. Given that there is no product approved specifically for the treatment of Chronic Fatigue Syndrome anywhere in the world, and at estimated prevalence rates of CFS in Australia and New Zealand, there could be 50,000 to 150,000 CFS patients with no dedicated treatment of this debilitating disease. We hope to be able to start providing Ampligen to the most severe of these patients during this year."
Recently, a blue-ribbon committee of the Institute of Medicine (IOM) of the National Academy of Sciences (USA) issued a comprehensive report on CFS reaffirming the seriousness of the disease and the need to accelerate research on potential treatments.
Thomas K. Equels, Executive Vice Chairman and CFO of Hemispherx, said, "We are very pleased to be collaborating with Emerge to provide Ampligen under these unique access programs and to work with them to gain formal regulatory approval. While continuing our efforts to gain approval in the US, we are seeking similar named-patient programs and approvals elsewhere."
