Research and development update
Q4 results - 02 February 2012
Diabetes care: Insulin and GLP-1
Degludec and DegludecPlus regulatory update
As previously announced, the new ultra-long-acting insulins, Degludec and DegludecPlus, have been submitted for regulatory review in Europe and the US. Furthermore, since the latest quarterly announcement in October 2011, Novo Nordisk has submitted Degludec and DegludecPlus for regulatory review in Switzerland and Canada. Finally, as previously announced, Degludec has been submitted in Japan.
The initial regulatory interactions are progressing as expected. In the US, the PDUFA action date has been set to 29 July 2012. In Europe, the regulatory review is also progressing as planned and the „Day 80‟ preliminary assessment report has been received.
Degludec phase 3a programme update
Novo Nordisk has now completed two extension studies of the phase 3a development programme for Degludec, providing two-year data on the efficacy and safety of Degludec in subjects with type 2 and type 1 diabetes, respectively.
In a 52+52-week trial (NN1250-3642, which is an extension of trial NN1250-3579), 1,030 insulin naïve people with type 2 diabetes were randomised 3:1 to either Degludec or insulin glargine, both given once daily in addition to metformin ± a DPP-IV inhibitor.
Degludec achieved the objective of showing HbA1c non-inferiority to insulin glargine, with HbA1c being maintained around 7% in both treatment arms from an original baseline of around 8.2%. For Degludec, the fasting plasma glucose level stayed low at around 6 mmol/l to the end of the study, which was statistically significantly lower than observed for insulin glargine. At the end of two years, Degludec maintained a lower risk of confirmed nocturnal hypoglycaemia compared to insulin glargine. The rate of confirmed nocturnal hypoglycaemic events was 43% lower with Degludec compared to insulin glargine, and the difference was statistically significant. In addition, the rate of severe hypoglycaemia was statistically significantly lower in the Degludec study arm as compared to the insulin glargine study arm. Degludec demonstrated a good safety and tolerability profile and there were no apparent differences between the treatment groups with respect to adverse events and standard safety parameters.
In another 52+52-week trial (NN1250-3644, which is an extension of trial NN1250-3583), 629 previous insulin users with type 1 diabetes were randomised 3:1 to either Degludec or insulin glargine, both given once daily in addition to mealtime insulin. Degludec achieved the objective of showing HbA1c non-inferiority to insulin glargine, with HbA1c being maintained around 7.4% in both treatment arms from an original baseline of around 7.7%. At the end of two years, Degludec maintained a lower risk of confirmed nocturnal hypoglycaemia compared to insulin glargine. The rate of confirmed nocturnal hypoglycaemic events was 25% lower with Degludec compared to insulin glargine group, and the difference was statistically significant. Degludec demonstrated a good safety and tolerability profile and there were no apparent differences between the treatment groups with respect to adverse events and standard safety parameters.
Levemir® approved in Europe for use during pregnancy
In December 2011, Levemir® was approved in Europe for use during pregnancy following a review of results from a Novo Nordisk phase 3b study in 265 pregnant women with type 1 diabetes.
Liraglutide-depot formulation phase 1 trial initiated
Novo Nordisk has initiated a phase 1 trial with a once-weekly depot formulation of liraglutide, which is the active ingredient in Victoza®, the once-daily GLP-1 analogue. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics of liraglutide-depot in 74 healthy subjects, and the trial is expected to conclude during the first half of 2012.
NN1953, oral basal insulin, successfully completes single-dose phase 1 trial
Novo Nordisk has completed a single-dose phase 1 trial with a novel oral basal insulin, NN1953. Following this trial, planning of a multiple-dose study is on-going.
NN9924, oral GLP-1, successfully completes two phase 1 trials
Novo Nordisk has completed single-dose and multiple-dose phase 1 trials with a novel oral GLP-1, NN9924. Following this trial, planning of additional phase 1 trials is on-going.
Novo Nordisk establishes type 1 diabetes research centre in Seattle, Washington, USA
As announced on 24 January 2012, Novo Nordisk plans to open a new type 1 diabetes research centre this summer located in its research site in Seattle, Washington, USA. The aspiration is to discover new drug candidates for the treatment or prevention of type 1 diabetes, and the research will focus on exploring new immune-based interventions in animal models and in early clinical trials.
Biopharmaceuticals: Haemophilia
Turoctocog alfa, a recombinant FVIII, completes phase 3a programme
Novo Nordisk has finalised the largest registration trial ever conducted for a factor VIII product. Turoctocog alfa has been dosed to 150 haemophilia A patients with 75 exposures each. The safety profile was positive with no patients developing an inhibitor and only few ad-verse events reported. A high success rate was observed in both treatment of bleeds and in reduction of number of bleeds. Turoctocog alfa also demonstrated a 100% success rate in preventing bleeds during surgery in both children and adults. Equally positive results were observed in a paediatric trial of turoctocog alfa including 63 children below 12 years of age. No inhibitory antibodies were reported in children, and a high efficacy in both treatment and prevention of bleeds was observed. Based on these results, Novo Nordisk will work towards submission to regulatory authorities during the second half of 2012.
Recombinant FXIII receives Complete Response Letter in the US
Novo Nordisk has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding its application to market a recombinant factor XIII compound for congenital factor XIII deficiency. The Complete Response Letter was issued by the FDA to inform Novo Nordisk that it has completed its review of the company‟s application and that the agency will require additional information prior to considering the product for approval. Novo Nordisk is evaluating the content of the response and will work closely with FDA to provide additional data.
Biopharmaceuticals: Growth hormone
NN8640, long-acting human growth hormone compound, initiates phase 1 trial
Novo Nordisk has initiated a phase 1 trial with a long-acting human growth hormone compound. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound in healthy male subjects.
Biopharmaceuticals: Inflammation
Anti-IL-20 for rheumatoid arthritis completes phase 2a
Novo Nordisk has completed a phase 2a trial with anti-IL-20 for rheumatoid arthritis with 67 participants. The trial met its primary endpoint of a statistically significant effect on the efficacy measure DAS28-CRP after 12 weeks of treatment with an acceptable safety and tolerability profile. Based on these data Novo Nordisk expects to progress anti-IL-20 into phase 2b in 2012.
