SELECTION AND DEVELOPMENT:
and Selection (continued)
Strategy: A critical step in selection of a product will be
an estimate of its manufacturing technology, with emphasis on
the ability to manufacture within at least two FDA approved good
manufacturing practice (GMP) facilities. Other considerations
in selection include the inherent cost of goods (COG) to manufacture
and an estimate of the continued availability of raw materials
required to manufacture the product at full production.
Elegance Issues: In order to fulfill a market need and provide
a sustainable presence, the product must have inherent or formulated
properties that allow for convenient dosing schedules, good absorption
from the GI tract, and stability under conditions of normal storage
and usage. An ideal oral product will have minimal metabolites
whether active or inactive. The more metabolites, the more questions
relative to toxicology and drug interaction issues are raised.
It will also have good bioavailability and a dosing schedule of
once or twice daily. In addition, the ideal product should be
made in tablets dosage forms instead of capsules to reduce the
cost of manufacturing. Significant emphasis will be placed on
a product that demonstrates a positive benefit in pharmcoeconomics,
i.e., a favorable comparison of costs and benefits relative to
the competition or standard of care in the care of the disease
VDDI Pharmaceuticals will give preference to products with a potential global
market of $200-500 million annually. VDDI Pharmaceuticals will examine closely
the conditions for a favorable market in the context of the competitive
pipeline, i.e., VDDI Pharmaceuticals would like to be either a market leader or
within the top three. A product with known competition will be
considered if it can be reasonably shown that it will have a hook
in the market for significant superiority in claims relative to
the competition. In many instances VDDI Pharmaceuticals will focus products with
a narrow initial indication, with the possibility of securing
a broad application in the future with expanded royalty-streams.
Concurrent with the development of the products, VDDI Pharmaceuticals will identify
a marketing partner.
Cost: The cost for development through Phase II will vary
by the indication and therapeutic target. VDDI Pharmaceuticals will not develop
compounds beyond Phase II to avoid the larger costs associated
with Phase III clinical studies.
Property: VDDI Pharmaceuticals will determine if the compound under consideration
is protected by a secure patent position, including the potential
for global patent registration.
model allows VDDI Pharmaceuticals to tailor effective project teams
according to the unique needs of the development program, by integrating
the services provided with a team of specialized vendors. VDDI Pharmaceuticals
will derive its income from royalty or marketing agreements associated
with the development of pharmaceutical and biopharmaceutical products.
VDDI Pharmaceuticals' management team is uniquely positioned to
execute acquisitions because of its depth of experience in global
will be developed from pre-clinical to Phase II trials by the drug
development partnerships. Once products complete Phase II trials
they will be licensed to third parties.
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