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news.Hemispherx Biopharma has executed an agreement with Emerge Health to seek approval for Alferon N Injection in Australia and New Zealand and to start distribution of the product in both countries on a named-patient basis, where appropriate.
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Both the firms will collaborate on seeking regulatory approval from Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe).
As part of the deal, Emerge will have exclusive license to sell, market and distribute Alferon N Injection in both the countries.
The deal will see Emerge implement regulatory-compliant programs to educate physicians about Alferon, while Hemispherx will support these efforts and will supply the product at a predetermined transfer price.
Emerge co-founders Peter Davey and Chris Rossidis said "Having visited Hemispherx upgraded Alferon manufacturing facility and met 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."
Alferon N is the only natural source, multi-species alpha interferon currently approved for sale in the US for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age or older.