novo-nordisk a/s-spons adr (NOVA) Snapshot

The U.S. Court of Appeals for the Federal Circuit partially affirmed a 2011 District Court decision, with a 2-1 ruling that a claim in a Novo Nordisk A/S patent related to the use of repaglinide in combination with metformin for the treatment of type 2 diabetes was invalid. This decision favors approval and launch of a generic repaglinide product. The Federal Circuit also reversed, with a unanimous 3-0 ruling, the District Court decision that Novo Nordisk had committed inequitable conduct during the time the company attempted to acquire the patent. Novo Nordisk continues to believe in the validity of the patent and is reviewing the ruling. Novo Nordisk expects to provide an update on the case in connection with the announcement of the financial results for the first six months of 2013 on 8 August 2013.

Novo Nordisk A/S announced the submission to the European Medicines Agency of the marketing authorisation application for the approval of IDegLira, the combination product of insulin degludec (Tresiba), the once daily new-generation basal insulin analogue, with an ultra-long duration of action, and liraglutide (Victoza), the once-daily human GLP-1 analogue. IDegLira has been developed for the treatment of people with type 2 diabetes. The filing of IDegLira is based on results from the DUALTM clinical trial programmes which involved around 2,000 people with type 2 diabetes, together with the extensive clinical data generated in the development programmes of the individual components insulin degludec and liraglutide. In the DUALTM programme people treated once-daily with IDegLira achieved an average HbA1c reduction of 1.9% in both trials. Among people treated with IDegLira, 81% of those previously treated with oral anti-diabetics and 60% of those previously treated with basal insulin achieved the ADA and the European Association for the Study of Diabetes (EASD) HbA1c treatment target of 7%. People treated with IDegLira experienced a low rate of hypoglycaemia, which was comparable to that of Tresiba, and achieved a reduction in body weight. The company intends to make IDegLira available in a prefilled delivery device based on the same technology platform as FlexTouch.

Novo Nordisk announced the headline results from a 56-week double-blind phase 3a clinical trial investigating the potential of liraglutide to induce and maintain weight loss in people without diabetes who are obese or overweight with comorbidities such as prediabetes, hypertension and dyslipidaemia. This is the third phase 3a trial to be completed as part of SCALE, the clinical development programme for liraglutide 3 mg as an obesity treatment. In the trial, 3,731 overweight or obese people were randomised 2:1 to treatment with liraglutide 3 mg or placebo, both in combination with diet and exercise. In the trial, people without signs of prediabetes were treated for 56 weeks, followed by a 12-week follow-up period. People with signs of prediabetes at the time of randomisation are currently continuing treatment for two additional years. The announced results are for all people at 56 weeks. From a mean baseline weight of 106 kg and a BMI of 38 kg/m, the average weight loss for people treated with liraglutide 3 mg at 56 weeks was 8.0% compared to 2.6% for people treated with placebo. The proportion of people achieving a weight loss of at least 5% was 64% for liraglutide 3 mg and 27% for placebo. The proportion of people achieving a weight loss of at least 10% was 33% for liraglutide 3 mg and 10% for placebo treatment. All differences between liraglutide and placebo were statistically significantly different and the trial met all three co-primary endpoints. Of all people participating in the trial, 61% had prediabetes at randomisation. At 56 weeks, 69% of the prediabetes subgroup treated with liraglutide 3 mg no longer showed signs of prediabetes, compared to 33% for the placebo-treated group. Of the 39% of the people without prediabetes at randomisation, 7% of the liraglutide 3 mg treated people developed prediabetes, compared to 21% of the people in the placebo group. Both differences between liraglutide 3 mg and placebo were statistically significant.