CaP

Aesthetic Medicine – BioLook™
Pre-clinical work to date indicates that BioSante's CaP technology performs well as a facial line filler (BioLook™) and may be as long lasting and safe as other injectable fillers. Preliminary results indicate long lasting effects with no adverse events. Further pre-clinical tests are being conducted to confirm the positive results and determine whether BioSante's CaP can extend the beneficial wrinkle-filling effects longer than those produced by the leading hyaluronic acid fillers, such as Restylane made by Medicis Pharmaceutical Corp., which typically last about six months after injection into the skin. Human clinical testing of CaP for this use is being planned and is expected to be initiated in 2009.

Novel Vaccine Adjuvant – BioVant™
CaP has demonstrated promise to enhance vaccine immune responses, leading to the use of lower vaccine dosage, while maintaining or improving effectiveness and offering an improved safety profile. It is not uncommon for vaccines to require the use of an adjuvant to generate adequate protective immunity to prevent or treat diseases. Currently, the only adjuvant used in vaccines approved by the FDA for use in humans is aluminum salts. However, adverse reactions, including irritation and inflammation around the injection site, can occur with aluminum salts. In addition, aluminum salts typically enhance an immune reaction that generally targets bacterial infections effectively, but may not be optimal in fighting viral infections. The Company's vaccine adjuvant, when combined with vaccines, has been shown in animal studies to elicit a higher immune response than non-adjuvanted vaccines and an immune response that is comparable to those adjuvanted with aluminum salts. Studies using various mainly viral vaccine antigens also suggest that the Company's CaP technology may sustain higher antibody levels over a longer period than both aluminum-formulated vaccines and non-adjuvanted vaccines.

The Company has conducted pre-clinical studies to demonstrate efficacy of its vaccine adjuvant using various viruses and bacteria including anthrax, hepatitis B, herpes simplex virus type-2 (HSV-2) and flu (H1N1 Swine, H5N1 avian and seasonal). These animal studies demonstrate that CaP elicits positive immune response to vaccines using either DNA-based or recombinant antigen formulations. In addition, the same adjuvant technology is effective as a delivery vehicle for both injected and non-injected vaccines.

Therapeutic Drug Delivery Platform – BioAir™/BioOral™
CaP is applicable as an alternative means of delivering protein and peptide therapeutics, a field showing promise since many biologics that have a strong therapeutic effect currently are limited to administration via injection. The development of novel, efficient, and convenient drug administration methods would be a significant healthcare improvement. The introduction of new delivery systems also allows drug companies to increase market share as well as extend their proprietary position. As a result, novel drug delivery systems make a significant contribution to global pharmaceutical sales as a strategic tool for expanding markets, extending product lifecycles and generating opportunities. As is generally recognized, macromolecules represent a promising class of compounds for pharmaceutical product development. The Company has developed what it believes are important formulations for delivering proteins via buccal and pulmonary routes using its biodegradable calcium phosphate nanoparticles as the vehicles. This approach has potential for controlled drug release, which could mean proteins may not need to be taken as often as with current methods. Also, because of its improved bioavailability, less protein might be needed per dose. This would make it more convenient and less expensive. The Company has completed pre-clinical tests showing that its biodegradable calcium phosphate nanoparticle vehicles enhance and extend the hypoglycemic effect of proteins when administered subcutaneously, buccally and pulmonarily. The Company believes that CaP can deliver many proteins (such as human Factor IX for hemophiliacs, Interferon alpha-2b for chronic hepatitis B treatment, a1-antitrypsin for the prophylaxis of venous thromboembolism) and peptides.

Transgenic Milk-Derived Recombinant Protein Processing
The Company has been issued a U.S. patent for the advanced method of selectively isolating biologically active therapeutic proteins from transgenic milk in a casein-free supernatant. Obtaining commercially viable yields of recombinant target protein from the milk of transgenic livestock remains a challenging task since milk is a complex multiphasic (fat, casein, micelles, whey) colloidal suspension. The Company's patented protein recovery process effectively addresses these well-known challenges and offers significant efficiency and economy compared to the currently employed methods. The Company's transgenic protein purification process offers several advantages over current methods including the fact that it dissolves casein clusters leaving the therapeutic proteins free, it removes casein from the therapeutic protein while preserving its biological activity and it leaves high concentrations of protein in the remaining crystal-clear whey fraction. In addition, it requires fewer processing steps to produce a casein-free protein mixture and can easily be scaled to a large pharmaceutical operation. This technology also offers a new tool for the milk processing industry for the more accurate and quantitative determination of certain milk components, such as growth hormone, that are raising health concerns of the public.