SemBioSys Genetics Inc., a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, has announced the completion of a Technology Transfer and Manufacturing agreement with Cangene Corporation.

A biopharmaceutical company and contract manufacturing organization, for the processing and purification of SemBioSys' plant-produced insulin. The contract is part of the company's preparations for its Investigational New Drug Application (IND) and the initiation of clinical trials. Cangene will manufacture insulin for SemBioSys' preclinical and early stage clinical development.

"Obtaining the services of a credible and reliable manufacturing Organisation like Cangene is a critical component of our clinical plan for insulin," said Andrew Baum, president and CEO of SemBioSys Genetics Inc. "The execution of this contract is the second significant development milestone for our insulin programme, following on our announcement this past July of successfully achieving commercially viable levels of insulin accumulation in safflower. We continue to advance our insulin development plan. In the near term, we expect to announce the regulatory strategy we will pursue in the US for our insulin product and to receive in vivo and in vitro bioequivalence results comparing insulin produced from safflower to commercially available insulin products."

With the signing of the contract, SemBioSys intends to immediately begin work with Cangene to implement technology transfer of the manufacturing process, which enables cGMP production of insulin from transgenic safflower. By solidifying the manufacturing capacity for insulin, SemBioSys remains on track to complete its preclinical work and file its IND in the fourth quarter of 2007.

Cangene will be responsible for purification of clinical grade material isolated from safflower seed produced by SemBioSys' proprietary production technology. The contract with Cangene allows SemBioSys to avoid the costs associated with building and maintaining a stand-alone manufacturing facility during the early stages of clinical development. Demand for insulin for the treatment of diabetes reached an estimated 5,500 kilograms in 2005 and is projected to increase to 16,000 kilograms by 2012. SemBioSys believes its safflower-produced insulin can reduce capital costs compared to existing insulin manufacturing by 70 per cent and product costs by 40 per cent. 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.