Viragen Inc and its majority-owned subsidiary, Viragen International Inc. has announced completion of a licensing agreement that grants exclusive rights to Orphan Australia to market, sell and distribute Multiferon (multi-subtype, human alpha interferon) in Australia and New Zealand.

Orphan Australia will initially focus its marketing efforts for Multiferon to target the treatment of high-risk malignant melanoma, as Australia and New Zealand report the highest melanoma incidence rates in the world.

While complete financial terms were not disclosed, the agreement provides Viragen with an up-front license fee, and additional milestone payments to be paid upon receipt of reimbursement authorization for Multiferon in Australia and possibly other countries to be added later. Viragen estimates the agreement to be valued at approximately $10 - 15 million (USD) per year for Viragen, pending regulatory approval and reimbursement authorization, and based on revenue forecasts for peak year sales.

"The likelihood of being diagnosed with melanoma in Australia is four fold higher than in the US or Europe, so this is a very important market opportunity, and we look forward to working closely with Orphan Australia to position Multiferon as a therapy option that will be preferred by physicians and patients," stated Viragen's president and CEO, Charles A. Rice.

According to Alastair Young, managing director of Orphan Australia, demand for a promising new melanoma treatment is high. "The current standard-of-care for high-risk malignant melanoma is surgical treatment and no effective adjuvant treatment currently exists, which leaves this patient category wide open for new, effective products. We are extremely excited regarding our ability to market Multiferon as an emerging, leading adjuvant treatment for this indication with excellent prospects to significantly improve patients' survival rates, and we believe there could be ample opportunities for this important product in other oncology indications as well. Orphan Australia is pleased to be able to bring this platform product to our territories."

Rice added, "With Orphan Australia's specialized expertise in targeting such niche cancer indications, we believe this company is an ideal licensee to launch Multiferon in Australia. Within this agreement, we have included the potential to expand this relationship into other countries throughout the Pacific/Asia region."

Orphan Australia will be responsible for obtaining regulatory approvals and will determine the most appropriate manner to enter other regional countries as well. It is expected that the regulatory process in Australia will take approximately 12 - 18 months. Clinicians who demand Multiferon for their patients prior to regulatory approval will be able to obtain it on a "Named-Patient" basis according to the local mechanisms for such supply.

Multiferon differs from single-subtype recombinant alpha interferon drug products in that it contains a unique mixture of multiple subtypes of human interferon (a1, a2, a8, a10, a14, a21).