SemBioSys submits IND for safflower-produced insulin t... (ntends to conduct a Phase I/II trial in ...)

SemBioSys submits IND for safflower-produced insulin to U.S. FDA

Date:7/29/2008

ntends to conduct a Phase I/II trial in the UK. The CTA requests approval to initiate a Phase I/II human clinical trial designed to enroll up to 30 healthy volunteers to demonstrate the bioequivalence of safflower-produced insulin to comparator insulin products. After discussions with the FDA in late 2006, SemBioSys was informed that safflower-produced insulin is eligible to receive approval through an abbreviated 505(b)(2) regulatory path. The European authorities have already published guidance documents concerning the approval of human insulin which are consistent with this approach.

The world market 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: demographic and dietary choices in the western world are causing an increase in the incidence of diabetes; and at the same time, countries in the rest of the world that are currently underserved in the insulin market, are demanding greater access to insulin at an affordable price. By 2012, independent estimates predict a US$15 billion insulin market. SemBioSys' plant-made insulin is expected to offer capital and operating cost reductions with the potential to enter the market as a low-cost, easily expandable source of insulin to meet this exploding 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 oils and agricultural biotechnology markets. More i
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SemBioSys submits IND for safflower-produced insulin t...(ntends to conduct a Phase I/II trial in ...)