Novo Nordisk risking $2B on holy grail of drug development

There are a handful of ‘holy grails’ in drug development. For the longest time, obesity has been on the list. Alzheimer’s is certainly one. And, a next generation cholesterol drug is another. Even with these, Novo Nordisk may have the inside track to a treatment that trumps them all.

With the related expansion of waste lines and diabetes around the world, oral insulin represents an unfathomable market opportunity. The day when diabetics can forever trash their needles and vials will be one celebrated by millions around the world.

The past decade or more has been dedicated to inhaled insulin products, which were briefly available to patients between September 2006 to October 2007 in the United States. Exubera, developed by Nektar Pharmaceuticals and sold by Pfizer, was discontinued in October 2007. According to then Chairman & CEO Jeffrey Kindler this is because Exubera “failed to gain acceptance among patients and physicians.” At the time of Exubera’s discontinuation, several other companies were pursuing inhaled insulin including Alkermes working with Lilly, Aradigm working with Novo Nordisk and Mannkind. By March 2008, all of these products had been discontinued except for MannKind’s Afrezza product. As of today, Afrezza remains under FDA review in a process that has been delayed by years and remains very uncertain.

So why the optimism? Novo Nordisk is betting $2 billion that it can develop an orally administered mega-blockbuster in the field. The progress is very, very early, proven only in animals and a handful of clinical patients. And, the process is riddled with challenges, mostly in terms of drug delivery, absorbtion and digestion. Novo Nordisk is not alone with upstarts Israel’s Oramed and India’s Biocon also making limited, early stage headway in oral insulin in the past few years.

But, a Novo Nordisk researcher put it best in the progress they have made: “When we started this, I thought it was going to be very, very difficult. Now I am really confident we will crack this one.”