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.