Key Developments: Novo Nordisk A/S (NVO)

NVO on New York Consolidated

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21 Oct 2014
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Latest Key Developments (Source: Significant Developments)

Novo Nordisk A/S initiates share repurchase programme
Monday, 15 Sep 2014 09:18am EDT 

Novo Nordisk A/S:Initiates share repurchase programme.This programme is part of overall share repurchase programme of up to 15.0 bln Uses Danish Crown to be executed during 12-month period beginning Jan. 30.  Full Article

Novo Nordisk A/S says discontinues activities within inflammatory disorders
Tuesday, 2 Sep 2014 02:46am EDT 

Novo Nordisk A/S:Expects that all ongoing clinical activities within inflammatory disorders will be finalized within the coming six months.Expects as a consequence of the discontinuation of all research and development activities within inflammatory disorders to incur a non-recurring cost of around 700 million Danish crowns.Expects to provide an update of the financial guidance for FY 2014 in connection with the release of the financial results for the 9M of FY 2014 on Oct 30.  Full Article

Novo Nordisk A/S maintains FY 2014 outlook
Wednesday, 6 Aug 2014 08:00pm EDT 

Novo Nordisk A/S:Still expects FY 2014 sales growth measured in local currencies to be 7-10 pct.FY 2014 operating profit growth measured in local currencies is still expected at around 10 pct.FY 2013 revenue of 83.572 billion Danish crowns.FY 2013 operating profit of 31.493 billion Danish crowns.FY 2014 revenue estimate of 88.034 billion Danish crowns - Thomson Reuters I/B/E/S.FY 2014 operating profit estimate of 33.367 billion Danish crowns - Thomson Reuters I/B/E/S.  Full Article

Novo Nordisk A/S receives positive opinion on Xultophy (IDegLira) from European regulatory authorities
Friday, 25 Jul 2014 07:28am EDT 

Novo Nordisk A/S:Announced that Committee for Medicinal Products for Human Use (CHMP) under European Medicines Agency (EMA) adopted positive opinion, recommending marketing authorisation for Xultophy for treatment of type 2 diabetes mellitus in adults.Xultophy is intended brand name for IDegLira, first once-daily single injection combination of Tresiba(insulin degludec) and Victoza(liraglutide), developed for treatment of type 2 diabetes.CHMP positive opinion recommends that Xultophy will be indicated for treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycaemic control.  Full Article

Novo Nordisk A/S says FDA approves Novoseven RT for treatment of Glanzmann'S Thrombasthenia-Reuters
Monday, 7 Jul 2014 01:50pm EDT 

Novo Nordisk A/S:FDA approves Novoseven RT for the treatment of Glanzmann'S Thrombasthenia (GT) with refractoriness-Reuters.Novoseven RT also is approved in the European Union for the treatment of bleeding episodes in patients with GT.  Full Article

Novo Nordisk A/S says diabetes drug appears effective for weight loss
Saturday, 14 Jun 2014 11:30am EDT 

Novo Nordisk A/S:Says its diabetes drug Victoza appears to be an effective weight loss therapy, as demonstrated by data from a late-stage clinical trial presented on June 14.In the 56-week study of 846 overweight or obese adults with type 2 diabetes, a daily injection of 3 milligrams of Victoza led to significantly greater weight loss than did a placebo.Patients taking the 3 mg dose of the drug, known chemically as liraglutide, had a mean loss of 5.9 percent of body weight.That compared with a loss of 4.6 percent for a 1.8 mg dose and just 2 percent loss for those who got a placebo.All patients were also put on a diet and exercise program.The results were presented at the American Diabetes Association meeting in San Francisco.  Full Article

Novo Nordisk announces results from SCALE Obesity and Pre-diabetes phase 3a trial
Thursday, 15 May 2014 08:00pm EDT 

Novo Nordisk A/S:Presents results from SCALE Obesity and Pre-diabetes phase 3a trial.After 56 weeks of treatment, liraglutide 3 mg in combination with diet and exercise, provided greater weight loss of 8 pct from baseline compared to 2.6 pct with placebo (p<0.0001).All treatment groups included a reduced-calorie diet and increased physical activity.The proportion of adults achieving weight loss of 5 pct or more of their baseline body weight was 64 pct for liraglutide 3 mg treatment compared to 27 percent for placebo (p<0.0001).33 pct of adults treated with liraglutide 3 mg achieved weight loss greater than 10 pct of their baseline body weight compared to 10 pct for placebo (p<0.0001).Treatment with liraglutide 3 mg reduced waist circumference by –8.19 cm, compared to –3.94 cm with placebo (p<0.0001).Treatment with liraglutide 3 mg improved blood glucose levels, blood pressure and lipids levels.Reported side effects were gastrointestinal (nausea and diarrhoea), which were mild to moderate, occurred shortly after liraglutide initiation, and were transient.Incidences of gallbladder disorders and pancreatitis were low but higher than in placebo-treated individuals.Gallbladder disorders were reported as 2.7 events per 100 patient-years of exposure (PYE) with liraglutide 3 mg treatment compared to 1.0 events per 100 PYE for placebo.Pancreatitis was reported as 0.3 events per 100 PYE with liraglutide 3 mg compared to 0.1 events per 100 PYE with placebo.  Full Article

Novo Nordisk A/S gives FY 2014 guidance
Thursday, 1 May 2014 02:00am EDT 

Novo Nordisk A/S:Sees FY 2014, sales growth measured in local currencies is now expected to be 7 pct. - 10pct.FY 2014 operating profit growth in local currencies is maintained at around 10 pct.  Full Article

Novo Nordisk says Tresiba and Victoza receive positive opinions from CHMP for label updates expanding indications for use in adults with type 2 diabetes
Thursday, 20 Mar 2014 08:00pm EDT 

Novo Nordisk A/S:Says the Committee for Medicinal Products for Human Use (CHMP) issues positive opinions for expanded use of Tresiba (insulin degludec) and Victoza (liraglutide) in type 2 diabetes.Says once the European Commission approves the label expansion, physicians will be able to prescribe Tresibain combination with GLP-1 receptor agonists, such as Victoza.Similarly, Victozacan be prescribed in combination with a basal insulin.The CHMP recommendation for both Tresiba and Victoza was based on efficacy and tolerability data from four phase 3 clinical trials3-6.All four trials were conducted in adults with type 2 diabetes.  Full Article

Novo Nordisk reports positive results from first phase 3 trial with N8-GP
Wednesday, 19 Mar 2014 08:27am EDT 

Novo Nordisk A/S:Completes pathfinder2, the first phase 3 trial with long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) for haemophilia A patients.In the trial, 175 patients were treated with a prophylactic regimen of 50 U/kg every fourth day and 11 patients received on-demand treatment, when bleedings occurred.Patients were treated for up to 21 months, resulting in median annualised bleeding rates of 1.3 and 30.9 episodes for patients treated prophylactically and on-demand, respectively.The results show that N8-GP has the potential to reduce the burden of treatment by decreasing the number of intravenous infusions while achieving strong results in terms of efficacy and safety for people with haemophilia A.Pathfinder2 is a multi-national trial evaluating safety and efficacy of N8-GP, when administered for prophylaxis and on-demand treatment in patients with haemophilia A, who are 12 years or older.  Full Article

Analysts see U.S. approval of Novo Nordisk's obesity drug by year-end

COPENHAGEN - The U.S. Food and Drug Administration is likely to approve Novo Nordisk's new drug to treat obesity this year, analysts said after wide expectations of an FDA decision late on Monday were not met.

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