FDA approves SemBioSys’ GLA safflower oil

The FDA has cleared Sonova 400, a gamma linolenic acid (GLA)-rich safflower oil developed by SemBioSys Genetics (TSX:SBS) for partner, Arcadia Biosciences, allowing it to be marketed and sold as an ingredient in dietary supplements.

Arcadia and its commercialization partner, Bioriginal Food and Science, expect to have commercial quantities of Sonova 400 available for sale in the first quarter of 2010.

“This is the first product developed using SemBioSys’ platform technology to complete a FDA review process, and thus represents a major milestone for SemBioSys,” CEO James Szarko said in a statement.

SemBioSys is in line to receive royalties from Sonova 400.  The company is also developing a bio-similar insulin and ApoA-1 Milano in its pharmaceutical programs.

GLA is an essential fatty acid with potential use in topical, medical food and nutrition products and may offer benefits for sufferers of blood platelet dysfunction, atherosclerosis and rheumatoid arthritis. The U.S. market for GLA oils is currently valued at more than $100-million (U.S.).