SemBioSys provides update on GLA-rich safflower oil
Calgary, Alberta, Canada
January 18, 2010
SemBioSys Genetics Inc. (TSX:SBS) today announced that its partner Arcadia Biosciences Inc., has successfully completed the U.S. Food and Drug Administration (FDA) regulatory process for SONOVA(TM) 400, a GLA-rich safflower oil. Following established procedures for New Dietary Ingredients, the FDA reviewed and acknowledged extensive data supporting the safety of SONOVA(TM) 400, allowing it to be marketed and sold as an ingredient in dietary supplements. Arcadia and its commercialization partner, Bioriginal Food and Science Corp., expect to have commercial quantities of SONOVA(TM) 400, available for sale in the first quarter of 2010 as an ingredient for dietary supplements.
In 2004, SemBioSys entered into a funded agreement with Arcadia to develop high GLA-expressing safflower plant lines using a proprietary Arcadia gene. In 2006, SemBioSys announced that it had developed safflower lines that had accumulated over 65% GLA content in the plant's oil, well in excess of the milestone target. Under the terms of the agreement, SemBioSys is entitled to receive royalties from Arcadia on GLA-associated commercial product sales, as well as milestone payments.
"This is the first product developed using SemBioSys' platform technology to complete a FDA review process, and thus represents a major milestone for SemBioSys," said James Szarko, President and Chief Executive Officer of SemBioSys. "Successful commercialization of SONOVA(TM) 400 will result in a royalty stream to SemBioSys and is an example of SemBioSys' strategy to generate revenues from existing non-pharmaceutical programs while SemBioSys focuses on the development of our BioSimilar Insulin and Apo AIMilano pharmaceutical programs."
Gamma linolenic acid or GLA, is an essential fatty acid with potential use in topical, medical food and nutrition products. Scientific studies suggest that GLA may offer benefits for sufferers of blood platelet dysfunction, atherosclerosis and rheumatoid arthritis. According to ICIS Chemical Business Americas, the U.S. market for GLA oils is currently valued at more than US$100 million. Current GLA supply is expensive, greatly limiting its use. The commercial availability of SONOVA(TM) 400, a low cost, reliable, concentrated and scalable source of GLA, should not only reduce these limitations, but significantly enhance market demand and utilization.
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Website: http://www.sembiosys.ca Published: January 18, 2010 |
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