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SemBioSys eligible to proceed with Phase I/II plant-produced insulin trial after submission of IND
Date:9/16/2008

ourth quarter of 2008. Prior to proceeding with the trial the company must await clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. SemBioSys' planned Phase I/II human clinical trial is designed to enroll up to 30 healthy volunteers in a three-arm study to demonstrate the bioequivalence of safflower-produced insulin to comparator insulin products. The European authorities are the first major healthcare regulators to have published guidance documents that ensure insulin is eligible to receive approval through an abbreviated regulatory path. Separately, the U.S. FDA has advised SemBioSys that safflower-produced insulin is eligible to receive approval through an abbreviated 505(b)(2) approval process.

The world market value for insulin is estimated to be in excess of US$7.1 billion today and the demand for insulin is projected to increase due to two factors. The growing incidence of diabetes combined with the expanded use of insulin therapy is expected to almost double insulin demand over the next five years and increase the global insulin market to over $15 billion by 2012. SemBioSys' plant-made insulin is expected to offer substantial capital and cost-of-goods reductions with the potential to enter the market as a low-cost, easily expandable source of insulin to meet exploding global demand.

About SemBioSys Genetics Inc.

Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company developing protein-based pharmaceuticals for metabolic and cardiovascular diseases. The Company's lead pharmaceutical candidates, produced in the plant host safflower, are recombinant human insulin to serve the rapidly expanding global diabetes market and Apo AIMilano, a next generation cardiovascular drug. In addition to its pharmaceutical products, SemBioSys and its subsidiary, Botaneco Specialty Ingredients Inc., are developing a series of non-pharmaceutical products addressing human topical, nutritional
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SOURCE SemBioSys Genetics Inc.
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