Research and development update
Q1 result - 30 April 2008
Diabetes Care
The data to be included in the liraglutide regulatory dossiers that will be submitted to the FDA and EMEA has recently been discussed with the US and EU regulatory authorities. Based on this, Novo Nordisk still expects to file for regulatory approval of liraglutide in the US and EU before the end of the second quarter of 2008. The filing for regulatory approval of liraglutide in Japan is still expected to take place in the third quarter of 2008.
At the annual meeting of the American Diabetes Association (ADA) to be held in San Francisco on 6-10 June 2008, Novo Nordisk expects to present detailed results from the global phase 3a programme with liraglutide.
As communicated on 14 January 2008, Novo Nordisk has refocused its clinical development activities within inhaled insulin and discontinued the development of AERx® iDMS, an inhaled fast-acting insulin. At the time of discontinuation of AERx® iDMS, specific safety concerns were not apparent and Novo Nordisk announced that R&D activities within inhalation of long-acting insulin and GLP-1 would continue. Following recent reports of lung cancer cases in type 2 diabetes patients treated with Exubera®, an inhaled insulin product from Pfizer, the likelihood of achieving a positive benefit:risk ratio for future pulmonary diabetes projects has become more uncertain and Novo Nordisk has consequently decided to stop all R&D activities in the field. As a consequence of this decision, Novo Nordisk will discontinue all pulmonary delivery projects in Denmark, as well as at the pulmonary R&D centre in Hayward, California. This decision will increase the non-recurring costs for 2008 relating to the discontinuation of the pulmonary delivery projects from a previous estimate of DKK 300 million related to the phase 3 AERx® iDMS project to a revised estimate of DKK 500 million for the discontinuation of the total pulmonary delivery project portfolio. Research at Novo Nordisk in Denmark will continue to focus on injection-based delivery and alternative non-invasive approaches to delivery of insulin, GLP-1 and other therapeutic proteins.
The results from a comparative study of dosing accuracy of Levemir® FlexPen® and Lantus® SoloStar® was recently published in Current Medical Research & Opinion. The study investigated the dosing accuracy at 5, 10 and 30 unit dose levels for both insulin delivery devices. At all doses investigated in the study, FlexPen® was reported to be more accurate, and the differences in accuracy between the two pens were statistically significant at all doses tested.
Biopharmaceuticals
On 25 April, Novo Nordisk received marketing authorisation from the European Commission for the room temperature stable version of NovoSeven®. A room temperature stable product is expected to deliver significant patient benefits including immediate access to treatment as well as fast and convenient administration when a bleeding episode occurs. Novo Nordisk expects to launch this upgraded version of NovoSeven® in Europe in the second half of 2008.
In January 2008, Novo Nordisk finalised the phase 2 safety study for the use of NovoSeven® in cardiac surgery. The study confirmed the safety profile known from the cardiac surgery setting and from previous studies of NovoSeven® outside of haemophilia patients with inhibitors. While the primary endpoint of this trial was safety, the trial also demonstrated the biologic haemostatic effect of NovoSeven®. Based on an assessment of Novo Nordisk’s possibilities within this indication with both NovoSeven® and NN1731, the next-generation version of recombinant factor VIIa, Novo Nordisk has decided not to progress with a pivotal phase 3 programme with NovoSeven®. Instead, a phase 2a study within cardiac surgery with NN1731 is expected to be initiated in the second half of 2009. The results from the phase 2 trial with NovoSeven® in cardiac surgery are expected to be published and presented at scientific congresses in 2008.
Furthermore, Novo Nordisk has completed a phase 1 dose escalation study with rFXIII in cardiac surgery. A total of 43 patients were randomised to treatment with either placebo or rFXIII. The study confirmed the ability of rFXIII to normalise the FXIII levels in the blood, which is expected to reduce the risk of bleeding. Based on this, Novo Nordisk expects to initiate a phase 2 study for the use of rFXIII in cardiac surgery mid-2009.
