Avanir Pharmaceuticals has signed an agreement with Bruno Farmaceutici giving Bruno the rights to manufacture and market Avanir's docosanol 10% cream as a treatment for cold sores. The exclusive agreement covers Italy, Europe's fourth largest topical anti-viral market.

Under terms of the agreement, Bruno Farmaceutici will be responsible for all sales and marketing activities, as well as manufacturing and distribution of the product. The terms of the agreement provide for Avanir to receive an upfront licensing payment and potential milestone payments. Avanir will also receive royalties on product sales.

Sold in the U.S. consumer market as Abreva by Avanir's licensee, GlaxoSmithKline, docosanol 10% cream is the only cold sore product approved by the U.S. Food and Drug Administration (FDA) for the over-the-counter (OTC) market. Now in its second year of sales, Abreva has captured the number one position in dollar sales with a 38% share of the market and the number two position in unit sales for lip remedies in the OTC market.

In addition to the United States, the topical treatment has been approved for marketing as an OTC product in Canada, Israel and Korea. AVANIR has submitted a new drug application to Swedish regulatory authorities seeking marketing approval of the drug in Sweden, which Avanir intends to act as the lead country in the mutual recognition process in Europe. Partner companies in the People's Republic of China and selected Middle Eastern countries will seek regulatory approval of docosanol 10% cream in their respective countries.