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SEMBIOSYS' PLANT-PRODUCED INSULIN EQUIVALENT TO HUMAN INSULIN

January 15, 2007

SemBioSys Genetics 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 company 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. The 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 other insulin treatments.

"Establishing insulin equivalence is the second major scientific milestone from our insulin program in the past six months," Andrew Baum, president and CEO of SemBioSys, said. "As a result of these achievements we expect that we will be able to submit an investigational new drug application 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."

Earlier this month SemBioSys announced that after meeting with the FDA it would proceed with an abbreviated regulatory path for safflower-produced insulin under a 505(b)(2) application. The company believes its safflower-produced insulin can reduce capital costs compared with existing insulin manufacturing by up to 70 percent and product costs by 40 percent or more.