Viragen and its majority-owned subsidiary, Viragen International have announced that a licensing agreement has been completed with Swedish Orphan International AB, granting exclusive marketing rights to Multiferon (multi-subtype, human alpha interferon) for the European Union (excluding previously licensed member states).
Under terms of the agreement, Viragen received approximately $2 million (1.5 million euro) as an up-front license fee and will serve as the sole manufacturer of the product. Swedish Orphan International will pay Viragen for Multiferon(R) at an agreed upon sales price, and, in addition, Viragen will receive double-digit royalties from Swedish Orphan International on their net sales.
Swedish Orphan International will also control and fund a significant portion of the costs for a planned European post-marketing clinical study. The melanoma post-marketing trial will further evaluate the use of Multiferon(R) for the first-line adjuvant treatment of high-risk malignant melanoma (Stages IIb-III).
Multiferon(R), which is manufactured by Viragen International’s ViraNative AB subsidiary in Sweden, is currently approved for malignant melanoma and other diseases in Sweden, and the parties will collaborate on registration throughout the European Union with new regulatory approvals expected by early 2008.
Headquartered in Stockholm with a focus on specialty drugs targeting patients with rare, life-threatening diseases, Swedish Orphan International, “The Pioneer Orphan Drug Company”, distributes more than 40 drug products throughout Europe in partnerships with more than 30 companies.
President and CEO, Bo Jesper Hansen, welcomed the addition of Multiferon(R) to Swedish Orphan International’s product portfolio, “Surgery remains the predominant treatment for malignant melanoma in Europe, however, the risk of relapse remains high for the patients with this severe malignant disease. In Multiferon(R), we are extremely excited about offering a safe, cost-effective, human interferon that can significantly reduce the risk of relapse and extend overall survival, thus giving promise for an increased life expectancy and quality of life for patients with malignant melanoma. Based on our extensive relationships with hospitals, physicians, patient advocacy groups and government agencies, we are committed to making this a priority product in our portfolio, as it holds high potential to emerge as a preferred therapy for patients with malignant melanoma and other severe diseases.”
“By licensing Multiferon(R) to one of the fastest growing companies in Europe and with their highly specialized marketing coverage in the orphan indications space, we believe we have the optimal collaborator in place to significantly increase our sales throughout Europe within the next few years,” stated Viragen’s President and CEO, Charles A. Rice.
Viragen is preparing to proceed with an EU regulatory process for Multiferon(R), through a registration pathway called the Mutual Recognition Procedure (MRP). This procedure allows a single registration dossier to be filed for approval among a targeted group of EU countries via one application and review process.
Mr. Rice added, “For a specialty product such as Multiferon(R), it is of vital importance that we work with an accomplished team for which our drug represents a source of dramatic growth, for them as well as for us. We are confident that Swedish Orphan International will appropriately ‘champion’ the product, and provide a level of commitment and investment to rapidly advance its uptake throughout Europe.”