SemBioSys Genetics Inc., a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, today announced that it is eligible to proceed with its planned Phase I/II human clinical trial of plant-produced insulin now that the 30-day review period of its Investigational New Drug (IND) application has passed. SemBioSys submitted the application in July to the U.S. Food and Drug Administration (FDA), which has now completed its review of the file. As previously announced, SemBioSys intends to conduct the Phase I/II insulin trial in Europe. Prior to proceeding with the planned trial in the United Kingdom, the company's Clinical Trial Application (CTA) must be reviewed by the appropriate European regulatory authorities.
"The company continues to achieve its insulin development milestones on time. Our recent accomplishments confirm our confidence in our regulatory and development strategy using plants as a low-cost production host for insulin. Plant-produced human recombinant insulin represents a major step forward in insulin production. We believe, furthermore, that these upcoming studies could prove to be the greatest achievement in insulin production since the advent of recombinant human insulin in the early 80's," said Andrew Baum, president and chief executive officer of SemBioSys. "The purpose of filing an IND in the U.S., even though we intend to conduct the trial in Europe, is to ensure that we can pursue U.S. and European regulatory approval of our plant-produced insulin contemporaneously. Conducting the planned insulin trial in Europe allows us to establish the bioequivalence of our safflower-produced insulin to commercially available insulin products from both the U.S. and Europe in a single trial."
SemBioSys plans to initiate a Phase I/II human trial of its safflower-produced insulin in the United Kingdom during the fourth quarter of 2008. Prior to proceeding with the trial the company must await clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. SemBioSys' planned Phase I/II human clinical trial is designed to enroll up to 30 healthy volunteers in a three-arm study to demonstrate the bioequivalence of safflower-produced insulin to comparator insulin products. The European authorities are the first major healthcare regulators to have published guidance documents that ensure insulin is eligible to receive approval through an abbreviated regulatory path. Separately, the U.S. FDA has advised SemBioSys that safflower-produced insulin is eligible to receive approval through an abbreviated 505(b)(2) approval process.
The world market value for insulin is estimated to be in excess of US$7.1 billion today and the demand for insulin is projected to increase due to two factors. The growing incidence of diabetes combined with the expanded use of insulin therapy is expected to almost double insulin demand over the next five years and increase the global insulin market to over $15 billion by 2012. SemBioSys' plant-made insulin is expected to offer substantial capital and cost-of-goods reductions with the potential to enter the market as a low-cost, easily expandable source of insulin to meet exploding global demand.
About SemBioSys Genetics Inc.
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company developing protein-based pharmaceuticals for metabolic and cardiovascular diseases. The Company's lead pharmaceutical candidates, produced in the plant host safflower, are recombinant human insulin to serve the rapidly expanding global diabetes market and Apo AIMilano, a next generation cardiovascular drug. In addition to its pharmaceutical products, SemBioSys and its subsidiary, Botaneco Specialty Ingredients Inc., are developing a series of non-pharmaceutical products addressing human topical, nutritional oils and agricultural biotechnology markets. More information is available and can be accessed 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 AI 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.