FDAnews
www.fdanews.com/articles/90596-orphan-australia-to-market-multiferon-in-australia-and-new-zealand

ORPHAN AUSTRALIA TO MARKET MULTIFERON IN AUSTRALIA AND NEW ZEALAND

December 29, 2006

Viragen and its majority-owned subsidiary, Viragen International, Dec. 28 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 per year for Viragen, pending regulatory approval and reimbursement authorization, and based on revenue forecasts for peak year sales.

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.

Alpha interferon is produced by the human immune system and helps improve the body's natural resistance to disease. 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). It is believed that each subtype, some of which are glycosylated, employs a specific biological activity, but more importantly, the subtypes act synergistically to elicit an overall effect. In February 2006, Multiferon was approved in Sweden for the first-line adjuvant treatment of high-risk malignant melanoma.