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Bioral® Technology

Encochleation Technology Overview

The Bioral® drug delivery technology is based upon encapsulating (or "encochleating") drugs to potentially deliver the drug safely and effectively. In the late 1960's, scientists began investigating the interactions of divalent cations with negatively charged lipid bilayers. They reported that the addition of calcium ions to small phosphatidylserine vesicles induced their collapse into discs which fused into large sheets of lipid. These lipid sheets rolled up into nanocrystalline structures, termed "cochleates", after the Greek name for a snail with a spiral shell.

Potential Applications

BDSI believes that Bioral® drug delivery technology represents a potentially important new delivery mechanism. While the characteristics and benefits of this technology will ultimately be established through clinical trials. BDSI nonclinical research indicates that Bioral® technology may have the following characteristics:

• Encapsulation: Bioral® drug delivery encapsulates, or entraps within a crystal matrix, the subject drug, rather than chemically bonding with the drug.
• Oral Availability: Bioral® drug delivery technology is being developed to enable oral availability of a broad spectrum of compounds, such as those with poor water solubility, including biopharmaceuticals, which have been difficult to administer orally. Bioral® drug delivery technology has the potential to be applied to substances which are not currently deliverable by traditional means so that they may be delivered orally or intranasally.
• Stability: Bioral® drug delivery technology is being developed to provide protection from degradation of the encochleated drug caused by exposure to adverse environmental conditions such as sunlight, oxygen, water and temperature.

Bioral® Products in Development

BDSI plans a diverse pipeline of products to be developed by applying the Bioral® drug delivery technology to a potentially broad array of established and promising pharmaceuticals. Each intended Bioral® product (i.e. drug encapsulated with our drug delivery technology) will, upon completion of development, require separate FDA regulatory approval, and accordingly, will be subject to the uncertainty, time and expense generally associated with the FDA regulatory process. BDSI's current proprietary Bioral® portfolio focuses on Bioral® Amphotericin B. An IND was filed in 2006 and will proceed into clinical development in 2008.