DRUG SELECTION AND DEVELOPMENT:

Product Emphasis

VDDI Pharmaceuticals will focus 80% of its business on the intermediate stages of clinical development (after discovery and preclinical toxicology) e.g., Phase I, II and in the case of cancer indications pivotal Phase II studies that typically involve less than a hundred patients. VDDI Pharmaceuticals will have a diversified portfolio of products in infectious disease and cancer, that have the potential for accelerated or fast track approvals. VDDI Pharmaceuticals' vision is to have an eventual product mix ratio of 80/20 with emphasize on opportunities from large pharmaceutical companies (80%) vs. small biotech and University (20%). In the near-term VDDI Pharmaceuticals will focus on products in the areas of infectious disease. VDDI Pharmaceuticals will concentrate on products with potential sales of $200-500 million.


A number of recent U.S. FDA regulatory changes have resulted in a more appropriate and favorable environment for drugs to treat life-threatening and serious diseases. One of these changes is the opportunity for conditional approval, which the FDA has made available for drugs to treat life-threatening diseases. This would allow a product to be approved after significant evidence of efficacy based on Phase II data, with the requirement that Phase III studies be performed, but the product could preferentially be made available to patients who need it based on very strong Phase II data. We will target opportunities to which this new approach will be applicable, particularly in cancer and infectious diseases. A second change is the fast track opportunity, which is an expedited and focused review on products, again, to treat serious and life-threatening diseases where there is no existing or adequate current therapy.


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