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Bioral Amphotericin B

BioDelivery Sciences International, Inc.

Drug Names(s): Bioral Amphotericin B

Description: Bioral technology is being evaluated as a potential means of orally delivering the antifungal agent Amphotericin B, a well established treatment for serious fungal infections. Bioral is a novel drug delivery system, based upon cochleate technology. Bioral encapsulates and protects a drug without chemically bonding to it and facilitates oral dosing of drugs that typically need to be given by intravenous administration. Alternating layers of lipids protect or “encapsulate” a drug molecule by rolling up or spiraling around it. This proprietary structure provides protection from degradation and allows the drug within the structure to remain intact, even though its outer layers may be exposed to harsh conditions, such as the digestive enzymes in the stomach. Use of the Bioral technology is being evaluated as a new means of overcoming the poor oral absorption of drugs, such as the antifungal drug Amphotericin B.

Deal Structure: In January 2009, BioDelivery Sciences announced the signing of a research collaboration and licensing agreement with the Drugs for Neglected Diseases initiative (DNDi).

DNDi will collaborate with BDSI on a non-exclusive basis in the design and conduct of a research and clinical development program to assess the efficacy and safety of Bioral Amphotericin B. Under the terms of the agreement, DNDi will execute a mutually agreed upon clinical development plan for Bioral Amphotericin B and seek regulatory approvals and distribution outside the U.S. and Europe for the diseases specified. The agreement covers many of the poor and marginalized countries of the world. BDSI will be responsible for manufacturing and providing clinical trial materials. All costs incurred will be the responsibility of DNDi.

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