Zacks_Analysts' Blog : Novo Nordisk's Degludec Filed in US - Analyst Blog

Novo Nordisk (NVO) recently filed regulatory application for its much anticipated pipeline candidates, Degludec and DegludecPlus, with the US Food and Drug Administration (FDA). Novo Nordisk has already applied for the approval of the candidates in the EU.

Degludec and DegludecPlus are next-generation insulin analogues for the treatment of type I and type II diabetes. Degludec is an ultra long-acting basal insulin while DegludecPlus is a fixed ratio combination of Degludec and NovoRapid.

Novo Nordisk conducted a large late stage clinical program with Degludec and DegludecPlus consisting of 17 separate trials. The program included 12 trials under the BEGIN program (Degludec) and 5 under the BOOST program (DegludecPlus). Data from the trials, which studied more than 10,000 type I and type II diabetes patients, confirmed the safety, efficacy and convenience of both candidates.

Late stage data showed that these insulins led to non-inferiority in control of the rate of glycemia with a reduced risk of hypoglycemia. Degludec particularly reduced nocturnal hypoglycemia (night-time episodes of excessively low blood sugar) when compared to the most frequently used insulin analogs. Nocturnal hypos are a condition highly feared by diabetics, and a drug that reduces such symptoms present a real commercial edge for the company.

In September 2011, Novo Nordisk announced data from a late stage trial of Degludec which revealed that Degludec can lead to reductions in blood glucose levels even if its dosing is delayed. Degludec can be given once daily up to 40 hours apart. Degludec led to reductions in HbA1c at 26 weeks by 1.28 percentage points to 7.2% versus Sanofi Aventis’ (SNY) Lantus. Fasting plasma glucose levels were also lower for Degludec compared to Lantus.

Our Recommendation

We have a Neutral recommendation on Novo Nordisk.

So far we are impressed by Novo Nordisk’s biggest drug Victoza’s performance. Victoza is doing well both in the US and Europe. Moreover, we believe that the next-generation insulin analogues, Degludec and DegludecPlus, hold significant potential for long-term growth at Novo Nordisk. Though we are encouraged by data from Degludec trials, we prefer to remain on the sidelines until Degludec and DegludecPlus gain approval. We currently have a long-term Neutral recommendation on Novo Nordisk.