Modified safflower turned into insulin
World demand for the drug could be met by 2010.
TORONTO GLOBE AND MAIL
In a breakthrough that could rival the discovery of insulin by Canadians Frederick Banting and Charles Best in 1921, a Calgary biotech company claims to have produced commercial quantities of human insulin from genetically modified safflower plants, a move that could change the economics of the diabetes market.
"We believe that when we're successful, people in the developing world, who otherwise wouldn't get insulin because there isn't enough supply or they can't afford it, will get it," said Andrew Baum, president and chief executive officer of SemBioSys Genetics Inc.
Currently, pharmaceutical companies use genetically engineered bacteria and yeast to produce synthetic insulin in large steel vats.
SemBioSys genetically manipulates plant-seed oils to create proteins that can be used to produce drugs and non-drug products.
By inserting a human insulin gene into a safflower plant, for example, the technology has led to the recovery of human insulin as the plant grows and seeds develop, the company says.
Baum said the company's next goal is to demonstrate, by the end of the year, that its product works as well as insulin currently on the market.
That would set the stage for a request to the U.S. Food and Drug Administration for approval to begin human clinical testing at the end of 2007, which would also likely draw the interest of a major pharmaceutical company to take part in the clinical trials. SemBioSys says it can make more than one kilogram of human insulin per acre of safflower production.
That amount could treat 2,500 diabetic patients for one year and, in turn, meet the world's projected insulin demand in 2010 with less than 16,000 acres of safflower production.
Worldwide demand for insulin is forecast to soar because more people are developing the disease and being diagnosed earlier in their lives, and because of the development of new products such has inhaled insulin, which requires five to 10 times the amount of injected insulin, Baum said.
The company
Baum, a 50-year-old industrial engineer by training, founded Calgene Inc. of Davis, Calif., in 1981, which went on to develop a genetically engineered "flavor saver tomato" that could be harvested and delivered ripe to grocery stores.
Monsanto Co., the world's biggest developer of genetically modified crops, acquired Calgene in 1997 for $240 million.
At Calgene, Baum worked with Maurice Moloney, a renowned plant molecular biologist who developed genetically modified canola.
Moloney, now 53, left the company in 1987 to become the first chairman of the biotechnology department at the University of Calgary, which was making a big push in the sector. At the university, he pursued his research and developed the technology that led to the creation of SemBioSys, a university spin-off.
"Morris called me out of the blue after the Monsanto deal and offered me a job as CEO of what was largely an academic project at the time that he wanted to take to the next level," Baum recalled. The company went public at the end of 2004.
In outlining the benefits of the technology, Baum said safflower-produced insulin could reduce capital costs by 70 percent and product costs by 40 percent.