US biotechnology company Viragen has been given the green light in Sweden to market Multiferon (multi-subtype, natural human alpha interferon) for the adjuvant treatment of malignant melanoma, and says it will launch this new label onto the market this month.

Specifically, Multiferon has been cleared for use in stages IIb and III malignant melanoma, a skin cancer, following dacarbazine (DTIC) therapy and surgical removal of the tumour. Approval was based on data showing a significant survival advantage for patients receiving this regimen, and there are also administration advantages, says the company. The current approved regimen includes treatment for up to 18 months, including high-dose therapy, whereas this latest nod will mean patients receiving two doses of dacarbazine followed by low-dose Multiferon three times weekly for six months. This, notes Viragen, “represents a significant reduction in total treatment time and cost.”

Viragen will now pursue pan-European approval through the mutual recognition procedure. “As we adapt our marketing activities in Sweden to immediately generate new sales of Multiferon, we will also provide support to our global license partners to expand this approval of Multiferon in our international markets.” Multiferon is currently marketed in 10 non-US markets for the first-line or rescue therapy for a broad range of infectious diseases and cancers.

According to Cancer Research UK, Sweden reports the highest per capita incidence of malignant melanoma in men in Europe and the third highest incidence in women (based on 2002 data). Globally, skin cancer accounts for more than 50% of all cancers; melanoma accounts for around 4% of these cases but 79% of deaths.

Market analysts Decision Resources note that the current worldwide melanoma therapeutics market is estimated at $437 million and is expected to exceed $1.1 billion worldwide by 2013. The European market is estimated to be approximately one-third of this total.