Insulin cost a growing concern

Note: This article appears in the Fall '09 issue of UCalgary Medicine magazine.  Check out the entire issue now!

Posted November 10, 2009

By Marta Cyperling

Maurice Moloney, PhD (left) and Dr. Morley Hollenberg in one of the SemBioSys laboratories: photo by Janelle PanCanadians may soon claim another insulin innovation.  SemBioSys, a Canadian biotechnology company born out of the University of Calgary has made a scientific breakthrough producing insulin in a genetically modified plant.

It was in the early 1920's that Canadians Dr. Fredrick Banting and Dr. Charles Best first discovered insulin, the protein hormone used in controlling diabetes.  When first discovered, insulin was produced by extracting the pancreas of animals.  Then in the 1980's researchers discovered a way to produce human insulin biosynthetically using bacterial cultures.  It is in this form of insulin that most diabetics receive today.

The idea to grow insulin in safflowers was first developed by Maurice Moloney PhD, in the Biological Sciences Department at the U of C, and he naturally began collaborating with his colleagues in the Faculty of Medicine.

"Insulin is right now the single largest protein pharmaceutical that's used in the world. There's roughly six tons of insulin produced per year right now" says Moloney. "If you're looking at something that's required in large amounts per year then you might want to look at the idea that plants are very productive and an inexpensive way of doing it."

Producing insulin synthetically is an expensive enterprise resulting in a significant disparity between global supply and demand. According to the World Health Organization (WHO), the west has only 35% of the world's diabetics and yet consumes over 70% of the world's insulin.

Working in one of the greenhouses with full size safflower plants: photo by Janelle Pan"It's very expensive to build the facilities that produce synthetic insulin. Some of the companies that are experts in this don't see how they'll get the rate of return that they do in the western world. It's one thing to do it in Canada, but if you tried to do the same thing in Bangalore then you're going to get a third of the price for your insulin, so you've got to be making it for a third of the price", says Moloney.  "Hence the idea of producing it in plants. If we do it in plants we can potentially break the price barrier in many parts of the world and give people an alternative source of insulin."

Dr. Morley Hollenberg and his colleague, Joe Goren, helped with the preliminary animal trials of the plant-derived human insulin at the University of Calgary.  Hollenberg is working with Moloney to get the product to market.  

"Being able to produce a lot of insulin at a cheaper price will also be very useful in developing an alternate route of delivery of the drug, something like a nasal spray which needs two to three times the amount of insulin as an injection."

Not only is SemBioSys creating a less expensive way of producing and delivering insulin, but the Calgary lab is also creating jobs for locally-trained scientists.

"A number of individuals who trained as post-docs in the Faculty of Medicine now work at SemBioSys," says Hollenberg. "We are building a pharmaceutical infrastructure in Alberta. Right now, we are training great people here but where will we employ them?  Trainees often go outside of the country for work because Canada does not have a large pharmaceutical drug infrastructure."

The final product: photo by Janelle PanThe safflower crops are processed into insulin at the Calgary lab, but the plants are actually grown on three regulated farms in Lethbridge, Alberta, Washington state and Chile.  Moloney says the raw materials are handled very carefully, according to the government permits and regulations. Because the safflower is a desert plant, it grows on marginal land and can easily be isolated from other crops using isolated fields.  In this way, SemBioSys can avoid any cross pollination and residual effects in the environment after harvest.

Based on their Phase I and II clinical trials in the UK, Moloney says the results look promising.  The pivotal Phase III of the clinical trials will begin once a partner has been identified, and SemBioSys anticipates its first insulin product could be approved by 2013.  Hollenberg hopes that the Endocrine Division of the Faculty of Medicine can participate in future trials of plant-produced insulin in diabetic patients.  The company is also researching the idea of placing other pharmaceutical crops into production.