Hemispherx Biopharma Inc. has made an agreement with Emerge Health Pty Ltd. to seek approval of Alferon N Injection in Australia and New Zealand and to commence distribution of Alferon 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 Alferon N Injection in Australia and New Zealand, Emerge will implement regulatory-compliant programs to educate physicians about Alferon. Hemispherx will support these efforts and will supply Alferon at a predetermined transfer price.
Peter Davey and Chris Rossidis, cofounders of Emerge, said in a joint statement, "Having visited Hemispherx's upgraded Alferon manufacturing facility and meeting some of the company's key people, we are impressed by what we saw and whom we met and believe that Alferon N Injection represents a significant opportunity in Australia and New Zealand for patients with recurring genital warts and those refractory to recombinant interferon."
Thomas Equels, executive vice chairman and chief financial officer, Hemispherx, said "We continue to make progress toward re-launching Alferon N Injection and are very pleased to be collaborating with Emerge to provide Alferon under these unique access programs and to work with them to gain formal regulatory approval."