TSX symbol: SBS
CALGARY, Jan. 18 /CNW/ - 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.
Calgary, Alberta-based SemBioSys is focused on leveraging its unique proprietary platform to manufacture high-value proteins and oils. SemBioSys' seed-based protein production system can provide for its partners product enablement, exceptionally low cost and unprecedented scalability. SemBioSys is applying the platform with high selectivity to products with tremendous clinical promise and value potential. The Company's current pharmaceutical development programs include insulin (SBS-1000, regulated as a biosimilar in Europe) and Apo AIMilano, a next-generation cardiovascular therapy. SemBioSys is listed on the Toronto Stock Exchange under the ticker SBS. More information is available at www.sembiosys.com.
This press release contains certain forward-looking statements, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and other similar expressions which constitute "forward-looking information" within the meaning of applicable securities laws. Forward-looking statements reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions and market size, the acceptance of an IND by the FDA in respect of clinical studies, the submission of a CTA to the appropriate European authorities, the successful initiation and timely and successful completion of clinical studies, the fact that Apo AIMilano is currently a development stage drug, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.
SOURCE SemBioSys Genetics Inc.
For further information: For further information: SemBioSys Genetics Inc., Abby Garfunkel, Investor Relations, Phone: (403) 717-4185, E-mail: firstname.lastname@example.org; The Equicom Group Inc., Ross Marshall, Vice President, Phone: (416) 815-0700 ext. 238, E-mail: email@example.com