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Novo Nordisk gives up on inflammation R&D

Follows disappointing trial results for arthritis drug
Novo Nordisk headquarters

The failure of Novo Nordisk's phase II data trial of NN826 in rheumatoid arthritis has had far-reaching consequences, with the company opting to pull out of inflammation R&D altogether.

Last month, Novo Nordisk reported that it had decided to discontinue development of the anti-interleukin-20 (IL-20) drug, the most advanced product in its inflammation pipeline. Now, it has decided to pull the plug on four other projects, including two candidates for Crohn's disease that had reached phase II.

The decision means that Novo Nordisk will concentrate its efforts on diabetes - its core franchise - and haemophilia therapies.

During the company's second-quarter results conference, chief executive Lars Rebien Sørensen confirmed that after a review of the data it had been decided to halt all trials related to NN826 after it failed to meet both primary and secondary endpoints in the study.

Announcing the decision yesterday, chief scientific officer Mads Krogsgaard Thomsen said the discontinuation of the drug would delay its earliest possible entry into the market for anti-inflammatory therapeutics "to the late 2020s [so] we have therefore decided to further increase our R&D efforts within diabetes which is our main business area."

"Significant unmet opportunities remain within diabetes, including prevention, obesity and diabetes complications," he added.

Novo Nordisk is in the process of rolling out its new long-acting insulin product Tresiba (insulin degludec) - despite a delay in the US caused by an FDA request for more data - as well as combination insulin product Ryzodeg (insulin degludec and insulin aspart) that has just been launched in Mexico, its first market.

The company is also on the cusp of approval for IDegLira/Xultophy (insulin degludec and liraglutide) after it was backed by regulatory advisors in Europe, setting it up to become the first combination of an insulin and GLP-1 receptor agonist to reach the market.

On top of this Novo is waiting for an FDA advisory committee meeting next week on Victoza (liraglutide) as a treatment for obesity. The drug is also in phase III testing as an adjunct to insulin in type 1 diabetes.

Meanwhile, the company has completed enrolment in a phase III trial of semaglutide, a once-weekly follow-up to Victoza. The trial will compare semaglutide's efficacy to Sanofi's once-daily Lantus (insulin glargine) product in type 2 diabetes.

The fate of the remainder of Novo Nordisk's inflammation pipeline - which consists of anti-IL21 drug NN8828 and anti-NKG2D candidate NN8555 for Crohn's disease and an anti-C5aR-215 compound (NN8210) for rheumatoid arthritis in preclinical development - remains uncertain.

Article by
Phil Taylor

3rd September 2014

From: Research

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