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SemBioSys Genetics Inc., a biotechnology company developing a broad pipeline
of protein-based pharmaceuticals and non-pharmaceutical products, announced
that its proprietary plant-produced insulin has been demonstrated in animal
models to be chemically, structurally and functionally equivalent to U.S. pharma
grade human insulin. The results of analytical, in vitro and in vivo assays
confirm that insulin produced in safflower, SemBioSys' commercial crop, is indistinguishable
from human insulin analytically and physiologically.
As a result of these achievements SemBioSys expects to submit an Investigational
New Drug Application (IND) later this year and initiate a Pharmacokinetic/Pharmacodynamic
study of safflower-produced insulin late in the fourth quarter of 2007.
SemBioSys has demonstrated functional equivalence through conducting insulin
tolerance testing in mice, which monitors blood glucose levels as the assay
variable, confirming that there is no statistically significant difference in
the pharmacodynamic response of safflower-produced insulin in comparison to
Eli Lilly's Humulin® treatments.
Demand for insulin for the treatment of diabetes reached an estimated 5,000
to 6,000 kilograms in 2005 and is projected to increase to 16,000 kilograms
by 2012. Demand for insulin is expected to grow due to a number of issues including;
earlier diagnosis of diabetes; increased diabetes incidence in the developed
world due to demographic trends, as well as consumption and behavioural habits;
increasing incidence in the developing world due to increasing affluence and
changing dietary habits; new alternative delivery methods that require between
five and ten times the amount of insulin as injection methods; and the use of
insulin as a treatment for type 2 diabetes patients earlier in the treatment
protocol as recommended by the consensus statement from the American Diabetes
Association and the European Association for the Study of Diabetes.
SemBioSys believes its safflower-produced insulin can reduce capital costs
compared to existing insulin manufacturing by up to 70% and product costs by
40% or more. Insulin currently produced using fermentation is estimated to require
$200 to $250 million in capital investment for 1,000 kilograms of production
capacity. In addition, because of the ease in scaling-up crop acreage, plant-produced
insulin offers significant improvements in the flexibility and speed of scale-up.
SemBioSys has five years of experience growing transgenic safflower in Canada,
the U.S., Mexico and Chile under permits issued by the pertinent regulatory
authorities.
www.sembiosys.com. webcast
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