CALGARY, July 18 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. , a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, today announced that the Company has achieved its commercial target levels of human insulin (insulin) accumulation in safflower with 1.2 percent of total seed protein. The results from the Company’s commercial plant system exceeded its target of one percent accumulation and confirm the potential of plant-produced insulin to fundamentally transform the economics and scale of insulin production.
“These results demonstrate that we have produced an authentic insulin molecule in safflower at commercially viable levels. Achieving our goal of one percent insulin accumulation in safflower confirms that SemBioSys has the potential to dramatically impact the economics of insulin manufacturing,” said Andrew Baum, President and CEO of SemBioSys Genetics Inc. “At these levels we can produce over one kilogram of insulin per acre of safflower production, which is enough to supply 2,500 patients for one year of treatment. We believe that we could meet the world’s total projected insulin demand in 2010 with less than 16,000 acres of crop production. Our plan is to continue to scale-up production for sufficient material to initiate clinical trials and file an Investigational New Drug (IND) application in the second half of 2007.”
SemBioSys intends to continue its preclinical program with safflower-derived insulin and assemble the components of its IND application including toxicology, immunology profiles and demonstration of efficacy in animal models. The Company expects to be in a position to submit an IND to the U.S. Food and Drug Administration in the second half of 2007 in preparation for a clinical trial in late 2007 or early 2008.
“Achieving our commercial insulin targets is the most significant milestone for our Company to date. The production of insulin at commercial levels in safflower significantly reduces the risk of our insulin development program and, from a broader perspective, provides us with confidence that our core technology and plant-made pharmaceuticals have a role as an enabling technology in the future of biopharmaceutical manufacturing,” continued Mr. Baum.
Demand for insulin for the treatment of diabetes reached an estimated 4,000 to 5,000 kilograms in 2005 and is projected to increase to 16,000 kilograms by 2010. Demand for insulin is expected to grow due to earlier diagnosis and increased incidence based on demographic trends, as well as, consumption and behavioural habits. Significant growth in demand is also expected from new alternative delivery methods, including inhaled insulin devices that require between five and ten times the amount of insulin as injection methods. Earlier this year the first inhaled insulin delivery technology, Pfizer’s Exubera(R) Inhalation Powder, received approval in the U.S. and EU. Pfizer expects to launch the product in the U.S. later this year.
SemBioSys believes its safflower-produced insulin can reduce capital costs compared to existing insulin manufacturing by 70% and product costs by 40%. SemBioSys believes safflower-produced insulin would require approximately $80 million in capital investment for 1,000 kilograms of insulin production capacity. Alternatively, insulin currently produced using fermentation is estimated to require $250 million in capital investment for 1,000 kilograms of production capacity. In addition, because of the ease in scaling-up crop acreage, plant-produced insulin offers significant improvements in the flexibility and speed of scale-up. SemBioSys has five years of experience growing transgenic safflower in Canada, the U.S., Mexico and Chile under permits issued by the pertinent regulatory authorities.
Insulin Production
Existing commercial insulin production methods typically rely on yeast (Saccharomyces cerevisiae) or bacteria (E. coli) genetically engineered to produce synthetic human insulin. These organisms are grown in large, capital-intensive steel bioreactors and the insulin is then extracted and purified for final formulation.
SemBioSys uses safflower to produce human insulin. Through its proprietary technology, SemBioSys is able to accumulate recombinant proteins, like insulin, in safflower. As the plant grows and the seed develops, the insulin protein is produced in the seed. Safflower production is based on conventional farming practices that have been adapted to ensure product integrity and confinement. The harvested seed is then processed using SemBioSys’ proprietary extraction process. Conventional enzymatic or chemical cleavage techniques and downstream processing methods are employed to produce purified insulin.
The selection of safflower as its commercial plant system was based on safflower’s superior technical profile as well as the advantages it offers to address the strict regulatory criteria expected for plant-made pharmaceuticals. Safflower is a low acreage crop that can be easily segregated from other safflower production. This, in combination with the biology of the crop’s pollination patterns facilitates containment of the crop.
Conference Call
SemBioSys will hold a conference call to discuss its insulin accumulation results today, July 18, 2006 at 11:00am eastern time. The call will be hosted by Mr. Andrew Baum, President and CEO of SemBioSys, and will be followed by a question and answer session. The dial in number for the conference call is 1 (800) 814-4857 or 1 (416) 644-3417.
A live audio webcast of the conference call will be available through www.sembiosys.com. Please connect to this website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. A replay of the webcast will be available for 90 days starting on July 18, 2006 at www.sembiosys.com. A replay of the conference call will also be available by telephone on July 18, 2006 through July 25, 2006. To access the replay, dial 1 (877) 289-8525 and enter reservation number 21196950 followed by the number sign.
About SemBioSys Genetics Inc. (www.sembiosys.com)
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company focused on the development, commercialization and production of biopharmaceuticals and non-pharmaceutical products based on its plant genetic engineering skills and proprietary oilbody-oleosin technology platform - the Stratosome(TM) Biologics System. Its two lead pharmaceutical product candidates are insulin and a developmental cardiovascular drug called Apo AI. It also has a series of non-pharmaceutical products addressing animal and aquaculture health, nutritional oils and human topical markets. SemBioSys currently has funded partnership agreements with Martek Biosciences Corporation, Lonza Inc. and Arcadia Biosciences, Inc.
This press release contains 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, which 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.
SemBioSys Genetics Inc.
CONTACT: SemBioSys Genetics Inc.: Mr. Andrew Baum, President and ChiefExecutive Officer, Phone: (403) 717-8767, Fax: (403) 250-3886, E-mail:bauma@sembiosys.com, Internet: www.sembiosys.com; Investor Relations: RossMarshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext. 238), Fax:(416) 815-0080, E-mail: rmarshall@equicomgroup.com