Novo Nordisk kills oral insulin, rejigs R&D to address U.S. payers

Novo Nordisk's ($NVO) new CEO won’t start till the New Year. But he’s already jumping in to reshape the company’s R&D priorities. The diabetes giant has opted to end its development of an oral form of insulin, which has long been an unattainable dream for the industry.

It’s also refocusing its pipeline to rely more upon in-licensing early stage projects and working with external academic collaborators. Substantively, the Danish pharma will shift more emphasis toward diabetes and obesity adjacent conditions such as nonalcoholic steatohepatitis (NASH), cardiovascular disease and chronic kidney disease.

“We will seek to move into adjacent areas, areas that are part of and yet go beyond diabetes,” said Novo Nordisk CSO and EVP Mads Krogsgaard Thomsen during a conference call on October 31. “These include NASH-Nonalcoholic Steatohepatitis proved to be kicked off by a Phase II trial with the semaglutide later this year, but also the buildup of the research pipeline. It also includes diabetic kidney disease, diabetic nephropathy and cardiovascular problems associated with diabetes.”

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These moves come as Novo Nordisk has been hit by payer difficulties in the U.S. that have resulted in worse-than-anticipated performance for its modern insulins and in reduced product pricing.

The biopharma narrowed its 2016 expectations to the lower end, reducing it to 5% to 6% from the prior range of 5% to 7%. It also sharply reduced its long-term operating profit growth projection to 5% from 10%.

Thomsen added: “The payer environment … means that in mature areas, such as insulin, for instance, it is really a question of having a very high innovation threshold to justify new projects. So, what we have done in the R&D management team, together with the executive management, is revisit the research strategy to the extent that we are driven by more and more external collaborations, co-creations, alliances and licenses.”

The company’s complete retreat on oral insulin is not too surprising given the long-standing difficulties associated with its development. It’s difficult to enable these large molecules to survive the stomach and then pass through the intestine into the bloodstream. The pharma argued that, unlike with oral semaglutide for which it is prepping Phase III testing, payers aren't supportive of the cost-effectiveness of oral insulin.

On the late stage diabetes front, Novo Nordisk’s focus is on semaglutide, its once-weekly injectable GLP1 for which it reported positive data last month. It said it expects to submit semaglutide to the FDA later this quarter, which it expects to be followed by a 12-month waiting period.

Incoming President and CEO Lars Fruergaard Jørgensen starts on January 1; he is currently Novo Nordisk’s EVP and head of corporate development. The change was announced last month, alongside a workforce reduction of 1,000 employees.