Research and development update
Q4 result - 2 February 2010
Diabetes Care
Significant regulatory progress has been made for the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue Victoza®, previously known under the INN name liraglutide. As announced on 20 January and 26 January, respectively, Victoza® is now also approved in Japan and the US. With these recent approvals, and the marketing authorisation granted by the European Commission on 30 June 2009, Victoza® has now been approved in all of the triad markets for diabetes treatment.
In the US, Victoza® is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. The US prescribing information includes a boxed warning based on the thyroid c-cell tumours found in rodent studies and Victoza® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma, and in patients with multiple endocrine neoplasia syndrome type 2. Novo Nordisk expects to launch Victoza® within weeks.
In Japan, Victoza® is the first GLP-1 analogue to be approved by the Ministry of Health, Labour and Welfare and the awarded indication covers monotherapy and combination therapy with sulfonylurea in type 2 diabetes. Novo Nordisk expects to launch Victoza® in Japan in the first half of 2010, upon completion of price negotiations.
Results from clinical trial extensions of LEAD™ 3, comparing Victoza® to a sulphonylurea, and the phase 3b trial comparing Victoza® to a DPPIV inhibitor, confirm both the superiority and sustainability of HbA1c reduction and weight loss that was seen in the main study periods with Victoza®. The study extensions have now documented treatment effect for periods of 3 years and 1 year in the two trials, respectively.
The phase 3 programmes, BEGIN™ and BOOST™, for the two new generation insulins, Degludec and DegludecPlus, respectively, continue to progress according to plan. The BEGIN™ programme includes a trial comparing Degludec with sitagliptin in insulin naïve type 2 diabetes patients. The BOOST™ programme includes two trials comparing once-daily injection of DegludecPlus with once-daily injection of insulin glargine in patients with type 2 diabetes, who are insulin naïve or already treated with insulin, respectively. Further trials are expected to beinitiated during the first half of 2010.
Recently, Novo Nordisk has initiated a phase 1 study investigating the benefits of a new combination product of insulin degludec and Victoza® for people with type 2 diabetes.
To improve the treatment outcomes and convenience in patients affected by diabetes, the development of tailor-made proteins for oral administration has been a long-standing Novo Nordisk aspiration. The biggest challenge in developing proteins for oral delivery is to achieve sufficient uptake of the drug into the body. Based on Novo Nordisk insight into the design of stable insulin and GLP-1 analogues, as well as formulation partnerships with Emisphere Technologies, Inc. and Merrion Pharmaceuticals plc, Novo Nordisk strives to overcome the hurdles related to degradation in the gastrointestinal tract and subsequent lack of absorption into the circulation.
The first phase 1 clinical trial with a Novo Nordisk insulin analogue designed for oral administration has been initiated with the aim of investigating the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers and people with type 1 and type 2 diabetes. The trial is planned to enrol about 80 people.
Within oral GLP-1, Novo Nordisk has initiated a phase 1 clinical trial with a long-acting GLP-1 analogue. The objective of the trial is to investigate the safety, tolerability and bioavailability in about 155 healthy volunteers.
Novo Nordisk has initiated a phase 1 trial with NN9161, to be developed for treatment of obesity. The trial will investigate safety, tolerability, pharmacokinetics and potential signs of efficacy in approximately 140 obese, but otherwise healthy volunteers.
Biopharmaceuticals
Both the US and European regulatory agencies have approved Vagifem® 10 mcg for local treatment of topical atrophy. Vagifem® 10 mcg represents a reduced strength of the already approved vaginal oestrogen product, Vagifem® 25 mcg. The introduction of a lower dose of Vagifem® is in line with the recommendations from the International Menopause Society (IMS), the North American Menopause Society (NAMS) and American College of Obstetricians & Gynecologists (ACOG) and Novo Nordisk expects to launch Vagifem® 10 mcg in the first quarter of 2010 in the US, and in the third quarter of 2010 in Europe.
In June 2009, the EU label for NovoSeven® RT was updated to reflect that safety and efficacy has not been established outside the approved indications for the drug. On 15 January 2010, the U.S. Food and Drug Administration (FDA) approved an update to the NovoSeven® RT label. A boxed warning was added to the NovoSeven® RT label, stating that serious arterial and venous thrombotic and thromboembolic events are associated with its use outside of licensed indications. This label change was initiated by Novo Nordisk as part of routine periodic safety updates.
To strengthen its activities within inflammation, Novo Nordisk has inlicensed a human anti-IL-21 monoclonal antibody (anti-IL-21 mAb) developed by ZymoGenetics, as well as broad intellectual property rights covering anti-IL-21 mAb and the development of other IL-21 antibodies. The anti-IL-21 mAb is a pre-IND candidate for the treatment of autoimmune and inflammatory diseases, with which Novo Nordisk expects to initiate a phase 1 trial in 2010.
