AVANIR Signs Agreement With Bruno Farmaceutici To Market Docosanol 10% Cream in Italy
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.
"In selecting well-positioned strategic partners, we are able to expand docosanol into new markets," said Gerald J. Yakatan, Ph.D., AVANIR's chief executive officer and president. "Italy is one of the largest markets in Europe for pharmaceutical products, especially for topical anti-viral treatments. We look forward to working with Bruno to develop a presence for docosanol in this market."
Sold in the U.S. consumer market as Abreva(TM) 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.
Bruno Farmaceutici, based in Rome, Italy, is a privately owned pharmaceutical company that has a commercial presence in both the prescription and OTC sectors. Bruno currently markets twenty products in the Italian market, some of which were in-licensed from other companies, including Aventis, Eli Lilly and Bristol Myers Squibb. The company was formed in 1996 by Dr. Antonio Bruno, a former marketing manager with Hoechst Marion Roussel and Gruppo Lepetit, who acquired from Hoechst Marion Roussel eleven pharmaceutical products currently sold by Bruno throughout Italy and an experienced sales network of professional reps.
AVANIR Pharmaceuticals, based in San Diego, is a biopharmaceutical drug discovery and development company. AVANIR is engaged in research, discovery, development and licensing of innovative drug products and, through its subsidiary Xenerex Biosciences, antibody generation services. The Company's website is www.avanir.com . To be added to AVANIR's investor email or fax lists, contact Tricia Ross via email at firstname.lastname@example.org or via phone at 310-407-6540.
The information contained in this press release, including any forward looking statements contained herein, should be reviewed in conjunction with the Company's Annual Report on Form 10-K, as amended, and other publicly available information regarding the Company, copies of which are available from the Company upon request. Such publicly available information sets forth many risks and uncertainties related to the Company's business and such statements, including such risks and uncertainties related to drug development and clinical trials. The Company can give no assurances that regulatory approval will be obtained in Europe. Market acceptance for drug products is unpredictable and substantially outside of the influence and/or control of the Company.
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