Novo has cracked the stem cell-code

Novo Nordisk has figured out a way to breed insulin-producing beta cells in a laboratory, which is a significant step towards a cure for type 1-diabetes. But for the pharmaceutical company the question remains; how great the business potential really is?

In the labs of the Hagedorn Institute, located in the Copenhagen suburb Gentofte, researchers are experimenting with stem cells – cells that in a not too distant future could become tiny marvels to patients suffering from type 1-diabetes.

The stem cells have the potential to take the form of any of the other cells in our body. The researchers at the Hagedorn Institute, which is an integrated part of the research section of Novo Nordisk, have made the cells transform into insulin-producing, glucose-sensitive beta cells – the exact cells which type 1-diabetics lack.

“We are so far along in the process that we can now see the first insulin-producing cells and have already seen them in our labs,” says Ole Dragsbæk Madsen.

He is a former Chief Research Officer and current VP and senior principle specialist at the Hagedorn Institute, where he pioneered the stem cell project that was launched in 2008.

Because stem cells have the ability to transform into any of the body’s other cells, the challenge is to make them into exactly the cell that the researchers need. At the Hagedorn Institute they have figured out a way to instruct the stem cells to become the pre-stage cells that are found in the pancreas during fetal development. Stem cells in this pre-stage possess the ability to develop large quantities of beta cells.

The final 30 %

If Novo Nordisk manages to mass-produce large quantities of beta cells in the lab, those cells could potentially be transferred to a type 1-diabetic, who would then be able to produce insulin again.

The researchers achieved the results very recently and they continue to work their way towards the potential cure using stem cells.

“We are where we need to be, and I believe that we have come 70 % of the way, out of the 100 % which would be the finalized, insulin-producing, glucose-sensitive beta cell that would form the basis of the method to generate these cells in unlimited quantities, and thereby cancel out the whole donor issue,” he says.

Not for a long time

So even though the researchers can now produce the key ingredient in a future cure for diabetes-1 - that may not be for a long time yet. In order to ease their way through the official approval process, Novo Nordisk will try to find a way to encapsulate the lab-cells in the patient, so they can easily be removed later on, and that takes time.

“Then it has to be approved for clinical testing and the whole process has to operate smoothly qualitatively speaking. So we are probably still looking at 8-10 years until the first of our cells could come into contact with humans,” Ole Dragsbæk Madsen points out and goes on:

“I think that the break-throughs will come bit by bit. It is a gradual process. You take one thing at a time and then you make sure that you can keep arriving at that stage in a reproducible manner,” he says.

A small group of diabetics

The world is now rife with type 2-diabetics, as the “Coca Cola culture” and the Western lifestyle takes hold everywhere. On a global scale about 366 million people have been diagnosed with diabetes, according to Diabetesforeningen (The Diabetes Association). But only 3-5 % of those people suffer from type 1-diabetes, which is in the region of 11-18 million people.

In comparison, 24 million people worldwide use the insulin products from Novo Nordisk at present.

Mike Rulis, Head of Communications in Novo Nordisk, won’t speculate about the specific economic advantages a potential treatment could bring the pharmaceutical company.

“There is still a long way to go until it becomes a reality, and there are many, many unknown factors. If we succeed, how much will it then cost to develop a treatment? It is all guesswork at this point to speculate about the market size,” he says.

For the privileged few

But the stem cell-based treatment will figure in a totally different price range than current treatment options, which can be as cheap as DKK 20 per day for the best insulin.

“Without being able to say exactly how much, it will be a lot more expensive. It won’t be overnight treatment for the masses. In the beginning it will probably be reserved for relatively few people, and as the technology becomes more widespread, more people could gain access to it over a long period of time,” says Mike Rulis.

Novo Nordisk probably won’t see a great profit from a future cure, according to Ole Dragsbæk Madsen.

“The project is aimed at something that might not have a great business potential, because it is aimed at a very small segment to begin with, but it will have a tremendous importance to that group of patients. So in terms of prestige, it is a great investment for Novo Nordisk,” says Ole Dragsbæk Madsen.

Competition looming

Meanwhile, other groups around the world are also conducting research with an eye to develop insulin-producing beta cells. However, Ole Dragsbæk Madsen believes that the Novo Nordisk scientists are on par with the best academic groups out there.

“From a competitive point of view we are doing very well.”

- translated by Martin Petersen

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