Plant Insulin
A biotechnology company announced that its proprietary plant-produced insulin has been demonstrated in animal models to be chemically, structurally, and functionally equivalent to U.S. pharmacy grade human insulin. The results of test assays confirm that insulin produced in safflower, SemBioSys' commercial crop, is indistinguishable from human insulin analytically and physiologically. As a result of this achievement the company expects that it will 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 or early in the first quarter of 2008, leading to an end of Phase II meeting with the FDA in 2008.
SemBioSys has confirmed the equivalence of safflower-produced insulin through analytical, in vitro, and in vivo animal assays. Chemical and structural authenticity have been confirmed through mass spectrometry and peptide fingerprint analysis. Functionality of safflower-produced insulin has been demonstrated using in vitro receptor phosphorylation assays, confirming biological activity in human cells. Finally, 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(®) and U.S.P. insulin 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 behavioral 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.
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. (SBS, 1/10/07).
