Viragen's Multiferon approved in Sweden for first-line treatment of malignant melanoma

By E. Janene Geiss

Philadelphia, Feb. 21 - Viragen, Inc. and its majority-owned subsidiary, Viragen International, Inc., announced Tuesday that the Swedish Medical Products Agency approved Multiferon (multi-subtype, natural human alpha interferon) for the first-line adjuvant treatment of high-risk (stages Iib-III) malignant melanoma following dacarbazine after surgical removal of tumors.

Viragen said it will officially launch this new malignant melanoma indication this month, according to a company news release.

"We have long been dedicated to the positioning of Multiferon as a leading therapy for certain cancers and this approval validates our many years of hard work devoted to providing new hope for patients for the treatment of malignant melanoma," Orjan Norberg, managing director of ViraNative AB, the Viragen subsidiary that manufactures Multiferon in Umea, Sweden, said in the release.

Approval for Multiferon in sequential combination with dacarbazine was granted based on clinical trial data that demonstrated a statistically significant advantage over untreated controls in terms of survival-without-distant metastasis and overall survival, officials said.

The currently approved therapy for high-risk malignant melanoma in Sweden may include recombinant alpha interferon following resection for up to 18 months, sometimes in a high-dose regimen.

By comparison, two doses of dacarbazine followed by low-dose Multiferon for six months represents a significant reduction in total treatment time and cost, officials said.

"We will now collaborate with the [Swedish Medical Products Agency] and European Union regulatory authorities to initiate the process for seeking broader European approvals 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," Viragen president and chief executive officer Charles A. Rice said in the release.

"In coordination with our expert Melanoma Advisory Board, we have initiated the process to conduct a post-marketing supporting clinical trial with Multiferon on a pan-European basis. The trial is scheduled to include up to 1,000 patients in multiple centers across Europe and is expected to build additional clinical evidence of the value of Multiferon in cancer therapy," Rice added.

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, officials said.

Skin cancer is the most common type of cancer, accounting for more than 50% of all cancers. Melanoma accounts for about 4% of skin cancer cases but causes 79% of skin cancer deaths.

Multiferon is a highly purified, multi-subtype, natural human alpha interferon. Marketed as "the natural choice," it is approved for sale in 10 non-U.S. international markets for the first-line or rescue therapy for a broad range of infectious diseases and cancers.

Viragen is a Plantation, Fla., biotechnology company engaged in the research, development, manufacture and commercialization of pharmaceutical proteins for the treatment of viral diseases and cancers.

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