Viragen Inc. announced here that its Multiferon, natural human alpha interferon, had been approved for sale in Bulgaria. The Bulgarian regulatory authorities approved an application filed by Viragen's distribution partner, Arriani Pharmaceuticals S.A., who holds the exclusive rights to distribute the drug in Greece and designated Balkan countries, Viragen announced here.
Multiferon, a highly purified, multi-subtype, natural human alpha interferon derived from human white blood cells, is now approved in Bulgaria for the second-line treatment of any and all diseases in which recombinant interferon therapy failed or the patient was unable to tolerate the regimen, possibly due to the formation of neutralizing antibodies. As an alternative to single-subtype, recombinant alpha interferons, Viragen's Swedish-manufactured natural interferon is primarily marketed for the treatment of hepatitis B, hepatitis C, chronic myelogenous leukaemia, hairy cell leukaemia, renal cell carcinoma and malignant melanoma.
"With this approval, we are now preparing to commence with our marketing program in Bulgaria, and we anticipate placing orders in the first quarter of 2005," stated Arriani Pharmaceutical's MD, CEO and Founder, Harry C. Lambridis. "As we build our sales program in Bulgaria, we will continue to take the measures necessary to achieve new regulatory approvals for Multiferon in Greece, Cyprus, Slovenia and Croatia for future growth," he added.
Viragen's Executive VP, Operations, Mel Rothberg Rothberg commented on plans to expand the drug's approved indications in Europe, "Based on the strength of the results of our recently reported phase II/III malignant melanoma study, we expect to submit an application in Sweden next month that seeks approval for Multiferon as adjuvant interferon therapy following dacarbazine after surgical removal of the tumour. Potential first-line approval in Sweden is expected to play an important role in our regulatory strategy to obtain broad EU approval for Multiferon - a priority goal for our business development programme," he said.
Viragen is a biotechnology company specializing in the research, development and commercialization of natural and recombinant protein-based drugs designed to treat a broad range of viral and malignant diseases.