CALGARY, June 26, 2007 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. , a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular disease, today announced positive preclinical data supporting the development of plant-derived recombinant human insulin. The Company presented its findings at the 67th Scientific Sessions of the American Diabetes Association (ADA) in Chicago. Specifically, the Company's abstract and poster presentation highlighted its recent accomplishments in the development of a highly-scalable, low-cost source of insulin, including:
- Results demonstrating that the Company exceeded its commercial target levels of insulin accumulation in safflower, its commercial plant system. - Laboratory results demonstrating that safflower-produced insulin is physically, structurally and physiologically indistinguishable from pharmaceutical-grade human recombinant insulin. - Laboratory results from competitive receptor binding assays demonstrating the functional equivalence of the Company's safflower-produced insulin to insulin reference standard. - Animal results from insulin tolerance test assays demonstrating the pharmacodynamic equivalence of safflower-derived insulin to pharmaceutical-grade insulin.
"These results validate the feasibility of our plant production technology for the large-scale manufacture of human insulin. Plants are a transformative platform for the production of biopharmaceuticals. They are ideally suited to large volume products such as human insulin, where capacity is in short supply. Plants offer unprecedented capacity and flexibility for low-cost biopharmaceutical manufacturing and provide by far the most attractive economics, both in terms of capital and cost of goods," said Andrew Baum, President and CEO of SemBioSys Genetics Inc. "We have confirmed our intention to pursue an abbreviated clinical trial under the 505(b)(2) rules of the Food and Drug Act after a meeting with the U.S. Food and Drug Administration late last year. We expect to enter directly into a Phase II trial in early 2008 with commercialization of safflower-produced insulin scheduled for as early as 2010."
During the Scientific Sessions on Sunday June 24th, Dr. Larry C. Deeb, ADA President, Medicine and Science, highlighted the need for increased access to insulin and insulin treatment as part of his presidential address. Dr. Deeb described the dire situation facing those suffering from type 1 diabetes in parts of Africa where the cost of insulin is a primary barrier to treatment.
Insulin is the largest volume recombinant biopharmaceutical product on the market today with production estimated at approximately 6,000 kilograms in 2006 and sales in excess of US$7.5 billion worldwide. SemBioSys estimates that the demand for insulin will increase to nearly 16,000 kilograms in 2012; fuelled by an increasing incidence of diabetes, increasing demand for access to insulin treatment in the developing world and adoption of alternate insulin delivery technologies, which require between 5 to 20 times more insulin than injection methods, in the developed world.
The scientific poster and abstract SemBioSys presented at the ADA were entitled: "Chemical and Biological Characterization of Recombinant Human Insulin Produced in Transgenic Plants." Abstract Number 0459-P by Joseph Boothe and colleagues at SemBioSys.
About SemBioSys Genetics Inc. (www.sembiosys.com)
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company developing insulin and other protein-based pharmaceuticals for metabolic and cardiovascular diseases. The Company's lead candidate is recombinant human insulin produced in the plant host safflower, to serve the rapidly expanding global diabetes market and to supply insulin for inhalation and other alternative insulin delivery technologies. The Company's other protein-based pharmaceutical candidate is a cardiovascular drug called Apo AI. SemBioSys is also developing a series of non-pharmaceutical products addressing animal and aquaculture health, nutritional oils and human topical markets.
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 Canadian 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, the successful and timely completion of clinical studies, 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.
CONTACT: SemB ioSys Genetics Inc., Mr. Andrew Baum, President and ChiefExecutive Officer, Phone: (403) 717-8767, Fax: (403) 250-3886, E-mail:, Internet: www.sembiosys.com; Investor Relations, RossMarshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext. 238), Fax:(416) 815-0080, E-mail: email@example.com firstname.lastname@example.org
Ticker Symbol: (Toronto:SBS.)
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