SEMBIOSYS SIGNS PACT FOR CANGENE PLANT-PRODUCED INSULIN.CSemBioSys Genetics Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :SBS See Small Business Server. ), Calgary, a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, has completed 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 organization like Cangene is a critical component of our clinical plan for insulin," said Andrew Baum, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 safflower, Eurasian thistlelike herb (Carthamus tinctorius) of the family Asteraceae (aster family). Safflower, or false saffron, has long been cultivated in S Asia and Egypt for food and medicine and as a costly but inferior substitute for the true saffron . 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 in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. and in vitro bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability. 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 aquaculture, the raising and harvesting of fresh- and saltwater plants and animals. The most economically important form of aquaculture is fish farming, an industry that accounts for an ever increasing share of world fisheries production. health, nutritional oils and human topical markets. SemBioSys currently has funded partnership agreements with Martek Biosciences Corporation Martek Biosciences is based in Columbia, MD, and manufactures DHA and ARA which is used in infant formula. Foods Containing Martek Products
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 Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. ). 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 Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. under the symbol CNJ CNJ College of New Jersey CNJ Central Railroad Company of New Jersey . For more information, visit http://www.sembiosys.com or call 403/717-8767. |
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