NVO » Topics » Research and development progress

This excerpt taken from the NVO 6-K filed Feb 9, 2007.
Research and development progress
During 2006, Novo Nordisk initiated a global phase 3 study for the use of liraglutide, the human GLP-1 analogue, in people with type 2 diabetes, and recruitment of all 3,800 patients was completed. Novo Nordisk also decided to initiate a phase 2 dose-ranging study for the potential use of liraglutide as an antiobesity agent for obese, non-diabetic persons. Furthermore, a global phase 3 study for AERx® iDMS, the pulmonary insulin, was initiated, and recruitment is ongoing.
     As communicated on 15 January 2007, Novo Nordisk has decided to discontinue research and development activities within the oral antidiabetic (OAD) segment and, instead, focus exclusively on therapeutic proteins, a key competence area for the company. As a consequence, all existing preclinical OAD projects and NN9101 (a glucokinase activator project currently in phase 1 clinical testing) are expected to be out-licensed.

Regulatory approvals
In 2006, Novo Nordisk received marketing authorisation from the European Commission for a label extension for NovoMix® 30, enabling diabetes patients in Europe to begin insulin therapy with a simple once-daily injection regimen.
     The European Commission also approved a label expansion for NovoRapid® to be used during pregnancy. The label expansion is a result of Novo Nordisk’s continued focus on expanding labels for the portfolio of modern insulins.
     In Europe, Novo Nordisk has received a positive opinion from the regulatory authorities for the use of Levemir® in combination treatment with oral antidiabetics (OAD) for people with type 2 diabetes. Following this, Novo Nordisk expects to receive marketing authorisa-tion from the European Commission during the first half of 2007.

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