Bioral® Amphotericin B
Systemic fungal infections continue to be a major domestic and international health care problem. Amphotericin B, which is currently delivered intravenously, is an established, commonly used drug to treat these infections. BDSI® is currently developing a Bioral® formulation of Amphotericin B for the oral treatment of fungal infections such as esophageal candidiasis and parasitic diseases such as Leishmaniasis. BDSI® submitted an IND to the FDA in December 2006 and initiated Phase 1 clinical development of the Bioral® formulation of Amphotericin B in 2008.
The Bioral® drug delivery system encochleates and appears to protect certain drugs from degradation in the gastrointestinal tract, facilitating their oral absorption. In the clinical development program, the Bioral® technology will be evaluated as a potential means of orally delivering the antifungal agent Amphotericin B, an important and well established treatment for serious fungal infections, which is currently administered only by intravenous (IV) injection.
According to data sources, the global antifungal market was approximately $3 billion in 2006 and is projected to grow to $4 billion by 2009. BDSI® market research indicates that Bioral® Amphotericin B may be able to achieve peak sales of approximately $400 million annually.