PRODUCT PORTFOLIO

Requirements for getting NDA or over-the- counter approval for botanical products are outlined in the “Guidance for Industry: Botanical Drug Products,” published by the FDA Center for Drug Evaluation and Research in 2004. FDA Botanical Drug Guidance allows for the expedited development of known plant derived drugs with extensive history of use, significantly reducing the cost and time for the introduction. The guidelines also provide for market exclusivity of NDA botanicals. Full characterization of all extract components or full elucidation of their interactions is not required, and some variation in the final composition of the botanical drug may be tolerated.

The company has access to a library of over 40,000 phytochemicals through its relationship with PhytoMyco Research Corporation, based in N.C.. This relationship ensures a continuous pipeline for development of new products and adequate raw material supply, as well as the ability to process and manufacture the botanical products in the U.S. under GLP/GMP.

Following is a table listing of our products and therapeutic areas of focus, which address large and growing markets with unmet medical needs:

The product portfolio is distinguished through the company's intellectual property and strong patent position, covering methods and composition for different leads, chemical derivatives, and standardized extracts. The company has 8 different patents and patent applications filed, with 1 issued, 5 published and 2 provisional. The company envisages supporting its preclinical and early phase clinical development program for selected products through a combination of investor raised funds and commercialization, through partnerships, of certain nutraceutical and other botanical products to which it has exclusive access. For Phase II and beyond and commercialization, the company is seeking partnerships with leaders in the selected therapeutic fields (See Partnerships).