COPENHAGEN (Reuters) - Denmark's Novo Nordisk, the world's largest insulin maker, is betting on a new way to stay ahead in the $40 billion-plus diabetes market by trying to develop the world's first once-weekly insulin injection.
It is an ambitious and risky project, with research still at an early stage, but Chief Science Officer Mads Krogsgaard Thomsen thinks the super long-acting insulin, known as LAI287, could be a boon for people wanting to minimize use of needles.
Developing a product that lasts a whole week is technically difficult, since scientists must ensure blood sugar levels do not go too high or too low.
The project, which is still in initial Phase I clinical testing and would not come to market before 2020, shows how Novo is exploring novel ways of treating diabetes, a disease that keeps spreading.
An estimated 592 million people are expected to be living with diabetes by 2035, up 55 percent from last year's level, according to the International Diabetes Federation. Most will have type 2 diabetes, which is linked to obesity and lack of exercise.
"Many diabetes patients cannot get over the injection barrier and therefore they are not treated with insulin as early in their disease as they should be," Thomsen told Reuters. "This insulin can help break down the injection barrier so that diabetics can start insulin therapy earlier."
It should work well for patients at the start of their illness, when the pancreas is still able to produce some insulin by itself, and who are not as dose-dependent as they will be later when the pancreas completely stops production.
A key issue for the ongoing clinical tests is whether LAI287 might push sugar levels dangerously low.
"We must examine whether diabetics will have the same low risk of hypoglycemia as with other insulins or whether the risk is increased because the drug works over a longer period," Thomsen said.
At the moment, Novo is looking to use the new product in people who have only had type 2 diabetes for a few years.
"If that goes well in Phase Ib testing, we will broaden it out and examine the weekly insulin in patients who have had the disease for several years," he said.
Novo Nordisk currently has a leading 47 percent share of the insulin drug market but it faces challenges, in part because its new long-acting once-daily insulin Tresiba, an important future growth driver, failed to win U.S. approval last year as hoped.
The world's biggest single insulin product is Sanofi's Lantus, which generates annual sales of about $8 billion. However, Lantus is due to lose patent protection in 2015, opening the door to cheaper rivals that could disrupt the wider market.
Only one other company in the world, California-based AntriaBio, is working on a once-a-week version of insulin due to the complexity involved in its development, said analyst Soren Lontoft Hansen from Sydbank.
AntriaBio's once-a-week injectable basal insulin AB101 is currently in pre-clinical development, according to its website.
"It is enormously difficult to develop a weekly insulin. Novo has some unique skills that come from having treated diabetes for 90 years," Hansen said.
The trick is to develop an injection that delivers insulin steadily over time.
"If a diabetic gets too much insulin there's a risk of hyperglycemia (dangerously high sugar levels) and if too little there's a risk of hypoglycemia," he said.
For now, industry analysts are taking a cautious stance on prospects for LAI287, given its early stage in tests. Citi analysts said in note last month that the drug could sell as much as $1.4 billion a year - but they gave it only a 15 percent chance of success.
Novo is also working on an oral version of insulin with a decision about whether to progress that into Phase II testing set to be made in 2015, while another project to make the first pill version of a different kind of diabetes medicine, known as a GLP-1 drug, is expected to report Phase II results early in 2015.
"The goal is to offer patients more options and build as broad a portfolio within diabetes as possible," said Thomsen.
Editing by Ben Hirschler and Pravin Char