New Plant Source for Insulin Developed

If it comes to market, it will reduce the cost of insulin by 40%.

SemBioSys Genetics Inc., a biotechnology company reported preclinical results of plant-produced insulin from the Company’s proprietary Stratosome(TM) Biologics System. SemBioSys’ research team led by Dr. Maurice Moloney, will publish the results in the January 2006 edition of the Plant Biotechnology Journal in an article titled, "Transgenic expression and recovery of biologically active recombinant human insulin from Arabidopsis thaliana seeds". The study demonstrates bio-equivalence of purified insulin from Arabidopsis seeds when compared with commercial insulin products in an animal model.

SemBioSys is developing insulin to serve the expanding diabetes market and to facilitate the commercialization of alternative insulin delivery technologies. Currently, injection is the only effective administration technique for insulin; however, significant progress has been made to develop technologies that will allow insulin to be administered in other ways. Leading developers of new delivery technologies include Sanofi-Aventis/Pfizer/Nektar, Novo Nordisk/Aradigm, Eli Lilly/Alkermes, Generex, MannKind and Emisphere.

The global market for insulin in 2003 was estimated to be US$4.3 billion and is projected to grow to US$7.1 billion by 2010. Subsequently, demand for insulin is expected to increase from 4,000 kilograms per year to 18,000 kilograms by 2010 due to growth in the incidence and diagnosis of diabetes and the commercialization of alternate delivery technologies, such as inhalation, that requires at least five times more insulin per dose. Access to a new high volume supply of insulin at a reasonable price will be a key issue to meet this expansion in demand. We believe that our safflower-produced insulin will allow us to supply this expanding market and reduce the cost of insulin production compared with current production methods. We project safflower produced insulin will reduce capital costs by 70% or more and product costs by more than 40% through a system that can be easily scaled as demand increases.

SemBioSys has achieved commercial levels of insulin production in its Arabidopsis model and demonstrated in animals that this insulin is chemically authentic and bioequivalent to human insulin. We are currently working to attain a commercial level of production in safflower. Our objective is to initiate clinical trials in late 2006 and then enter into one or more development or commercialization partnerships.