Oral insulin represents one of the holy grails in the drug development field: the kind of market opportunity that analysts speculate would be worth billions a year in income. And Novo Nordisk ($NVO) says it's willing to bet $2 billion that it can score a mega-blockbuster success in the field.
The company has a long way to go. Regulators have set a very high bar on cardiovascular safety for a mass market like this. And so far, as Bloomberg makes clear in its in-depth article, Novo has only completed animal studies and tested their experimental version in 100 humans, with NN1953 just past the first round.
There are a variety of challenges for the scientists involved. Oral insulin would have to make it into the gut, no easy task, and remain in the bloodstream long enough to get absorbed so that anyone taking the drug wouldn't be exposed to hypoglycemia. Digestion will influence efficacy and the industry has already seen a number of attempts at this go down in flames. And even if they succeed, a pill would only work for people who can still naturally produce some insulin. All that has made a number of analysts very cautious, if not completely skeptical. But Novo execs tells the business news wire that they will be ready to select the company's mid-stage candidate later in the year.
"When we started this, I thought it was going to be very, very difficult," Lars Fogh Iversen, head of the diabetes protein engineering unit, tells Bloomberg. "Now I am really confident we will crack this one."
- here's the article from Bloomberg