BOTANICAL DRUGS - Sunrise Opportunity for a New Class of Drugs

Prior to 2004, two types of drug regulations existed within the US FDA: (1) New Chemical Entities (NCEs) as regulated by CDER; and (2) Biologicals and Vaccines regulated by CBER.

Despite many botanical drug candidates and compositions (derived from plant origin) being tested in animals and botanical drug research being federally funded at NIH, this class of drugs did not have a guideline or process to market under US FDA regulations. In 2004, recognizing the potential and promise of botanical drugs, US FDA released a botanical drug approval guideline. To date, one drug (a topical application developed by Medigene for external genital warts) has achieved NDA status under this newly issued guideline.

All of the drug candidates being developed by Indus Biotech are compliant with botanical drug guidelines of US FDA as well.
More importantly, as the Company develops purified single molecules, which are derived from plants as the starting point, these drug candidates can also be developed as NCEs.

Indus Biotech’s Business Strategy

Recognizing that the business of drug discovery is an expensive and time-consuming activity, Indus Biotech has evolved a strategy of developing cash generating businesses in the short-term through the use of its unique, patented and clinically tested poly-molecular formulations, while continuing its drug development activity that will create high value for the company over the long-term.

Starting with chosen food chain raw materials, the Company’s proprietary platform technology for extraction, isolation and purification creates several poly-molecular formulations with physiological activity that can be positioned for marketing along the value chain illustration shown below: While NCE and Botanical Drugs represent the core focus of Indus Biotech as value generation over the long term, Exercise Physiology and Herbal Medicine as shown below are currently being used to generate revenues over the short-term for the Company. Such a strategy ensures that Indus Biotech is a profitable company with no cash burn.