BioDelivery announces licensing of its topical BioNasal amphotericin B for chronic sinusitis.

BioDelivery Sciences International, Inc. (Newark, NJ) announced it has licensed a topical formulation of its lead product, encochleated amphotericin B to Accentia, Inc. Accentia, Inc., a Hopkins Capital Group company, is a privately-held, vertically-integrated specialty biopharmaceutical company that provides comprehensive biopharmaceutical services, including product commercialization, clinical manufacturing, contract sales and product distribution. Accentia is commercializing technology licensed from Mayo Foundation for Medical Education and Research for the treatment of chronic sinusitis (rhinosinusitis) in the United States and European Union. Chronic rhinosinusitis (CRS) is the largest market opportunities lacking an approved pharmaceutical in the United States. CRS affects an estimated 37 million patients in the United States and a comparable number in the European Union. For purposes of market-size comparison, the hypercholesterolemic market in the United States accounts for the top-selling pharmaceuticals in the industry and the market is estimated to be approximately 36 million patients. The technology consists of using low-dose topical antifungals to control the debilitating symptoms of chronic rhinosinusitis. According to the terms of the license, Accentia will pay BDSI a running royalty of 12-14% on net sales in the United States. Accentia estimates that annual prescription cost will be approximately $1000/patient. Accentia is responsible for all expenses related to the development of an encochleated BioNasal amphotericin B for the indication of CRS in the United States and European Union including the filing of an IND and clinical trials. BDSI retains world-wide rights to the oral and intravenous formulations of encochleated amphotericin B and non-United States and non-European Union rights to a topical formulation of BioNasal encochleated amphotericin B.

"We are delighted to be able to commercialize the unique, patented BDSI nanocochleate delivery technology using amphotericin B for the indication of chronic rhinosinusitis. We believe that amphotericin B is the most promising topical antifungal for this indication because it is an extremely powerful fungicidal and its use in CRS is very unlikely to lead to acquired resistance. Because amphotericin B in solution has a limited shelf life of just a few weeks, and because it normally requires refrigeration, we believe that the encochleated formulation is the only practical way to develop a commercially viable topical amphotericin B with extended stability at room temperature", said Martin Baum, President of New Business Development for Accentia. "CRS is a very important chronic disease based on a frustrating inability to identify its causation. Investigators at the Mayo Clinic have published clinical studies reporting a new disease paradigm wherein ubiquitous saprophytic mold elicits an immune-mediated response in affected patients, but not in unaffected patients. By using low-dose topical amphotericin B, it was possible to target the origin of this disease in these clinical studies, which provides many patients with symptomatic improvement."

Accentia is in the business of commercializing targeted therapeutics in patent -protected drug delivery technologies in the respiratory, oncology and critical care areas. A rapidly growing market, targeted therapeutics focus their action to specific cellular targets, reducing undesirable collateral damage while boosting efficacy. Accentia, through its majority-owned subsidiary Biovest International, Inc., is working to accelerate the development of an autologous vaccine for non-Hodgkins lymphoma produced from a hybridoma using the Biovest proprietary bioreactor. Accentia and its subsidiaries collectively provide vertically integrated capabilities that include pre-market research and outcomes analyses; marketing and selling branded pharmaceuticals by licensing or acquiring under-promoted products and late stage development compounds; and a proprietary bioreactor technology to perform contract production of custom-designed biologics, including vaccines.

BioDelivery Sciences International, Inc.

[phone]

www.bdsinternational.com