SEMBIOSYS SIGNS PACT FOR CANGENE PLANT-PRODUCED INSULIN.
"Obtaining the services of a credible and reliable manufacturing organization 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 program, 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 U.S. 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% and product costs by 40%. 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.
About SemBioSys Genetics Inc.
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.
About Cangene Corporation
Cangene is one of Canada's largest biopharmaceutical companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. Cangene also provides contract research and manufacturing services using its drug-manufacturing expertise and the resources of Chesapeake Biological Laboratories, Inc. (a wholly owned subsidiary). The company has manufacturing facilities in Winnipeg, Manitoba and Baltimore, Maryland.
For more information, visit http://www.cangene.com. Cangene is listed on the Toronto Stock Exchange under the symbol CNJ.
For more information, visit http://www.sembiosys.com or call 403/717-8767.
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|Date:||Jan 1, 2007|
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