Key Developments: Novo Nordisk A/S (NVO)
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21 May 2013
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Latest Key Developments (Source: Significant Developments)
Novo Nordisk A/S Reports Positive Results from First Phase 3 Trial with Long-Acting Factor IX for Treatment of Haemophilia B
Novo Nordisk A/S announced that Company has reported positive results from first phase 3 trial with long-acting factor IX for treatment of haemophilia B. In the trial, 74 patients were treated for six months on-demand, or 12 months by a prophylactic regimen of 40 U/kg or 10 U/kg N9-GP once weekly. The median bleeding rate for patients treated on-demand was 15.6 episodes per year. Patients on prophylaxis had a median annualized bleeding rate of 1.0 and 2.9 episodes per year, when treated with weekly doses of 40 U/kg and 10 U/kg, respectively. Among patients randomized to receive 40 U/kg N9-GP, 99% of bleeding episodes were treated with only one infusion, and two-thirds of the patients experienced complete resolution of bleeding in their target joints. Patients in this dose group also reported an improvement in quality of life during the trial. Pharmacokinetic data documented a steady state half-life of 110 hours. In the trial, N9-GP appeared to have a safe and well-tolerated profile. No patients in the trial developed inhibitors, and no apparent differences between the treatment groups were observed with respect to adverse events and standard safety parameters. Regulatory submission of N9-GP in all major markets is expected in 2015 to enable validation of the commercial scale production. Full Article
Novo Nordisk A/S Specifies FY 2013 Sales Growth Guidance, Confirms FY 2013 Operating Profit Guidance and Lowers FY 2013 Net Income Guidance
Novo Nordisk A/S announced that for the fiscal year 2013, sales growth measured in local currencies is now expected to be between 9% and 11%, operating profit growth measured in local currencies is still expected to be around 10%, and net income is expected to amount to approximately DKK 900 million. Previously, the Company expected sales growth of between 8% and 11% and net income of approximately DKK 1,400 million. For the fiscal year 2012, the Company reported revenue of DKK 78,026.00 million and operating profit of DKK 29,474.00 million. Full Article
Novo Nordisk A/S Concludes Share Repurchase Program
Novo Nordisk A/S announced that on January 31, 2013 it initiated a share repurchase program. Under the program the Company has repurchased B shares for an amount of DKK 3.0 billion in the period from January 31, 2013 to April 29, 2013. The program is concluded. Novo Nordisk owns a total of 10,645,508 treasury shares, corresponding to 1.9% of the share capital. The total amount of shares in the Company is 550,000,000 including treasury shares. Full Article
Merrion Pharmaceuticals' Partner Novo Nordisk A/S Conducts Phase I Study of NN1954-Reuters
Reuters reported that Merrion Pharmaceuticals Plc announced that Novo Nordisk A/S has on March 20, 2013 conducted a single-dose Phase I study of a new oral insulin NN1954. Merrion Pharmaceuticals Plc is partner of Novo Nordisk A/S and has helped in the formulation of the new insulin. NN1954 is a long-acting oral basal insulin analogue for oral therapy, and it is Novo Nordisk, which owns the rights to the agent. Full Article
Novo Nordisk A/S Appoints Goran Ando as New Chairman
Novo Nordisk A/S announced that it has appointed Goran Ando as the new Chairman of the Company's Board of Directors. Full Article
Novo Nordisk A/S Announces Results from Phase 3a Clinical Trial for Liraglutide
Novo Nordisk A/S announced the headline results from a 56-week, double-blind phase 3a clinical trial investigating the potential of liraglutide to induce and maintain weight loss in overweight or obese people with type 2 diabetes. This is the second phase 3a trial to be completed as part of SCALETM, the clinical development program for liraglutide 3 mg as an obesity treatment. In the trial, 846 overweight or obese people with type 2 diabetes were randomized 2:1:1 to treatment with liraglutide 3 mg, liraglutide 1.8 mg or placebo. After 56 weeks, treatment was discontinued and the subjects were followed during a 12-week observational period. From a mean baseline weight of approximately 106 kg and a BMI of 37, the weight loss for people treated with liraglutide 3 mg and liraglutide 1.8 mg after 56 weeks were 6% and 5%, respectively compared to a 2% weight loss for people treated with placebo. The proportion of people achieving a weight loss of at least 5% or 10% was 50% and 22% for liraglutide 3 mg, 35% and 13% for liraglutide 1.8 mg, and 13% and 4% for placebo treatment. During the 12- week follow-up period after treatment discontinuation, people in both liraglutide treatment groups experienced a moderate weight regain. Starting from a baseline HbA1C of 8.0%, approximately 69%, 67% and 27% of people treated with liraglutide 3 mg, liraglutide 1.8 mg and placebo achieved the HbA1c treatment target of 7%. Full Article
Novo Nordisk A/S Announces Share Repurchase Programme
Novo Nordisk A/S announced that on January 31, 2013 Novo Nordisk initiated a share repurchase programme in accordance with the provisions of the European Commission's regulation no 2273/2003 of December 22, 2003, also referred to as the Safe Harbour rules. Under the programme Novo Nordisk will repurchase B shares for an amount up to DKK3.0 billion in the period from January 31, 2013 to April 29, 2013. Full Article
Novo Nordisk A/S Proposes FY 2012 Dividend
Novo Nordisk A/S announced that the Board of Directors proposes to the Annual General Meeting (AGM) that a dividend of DKK 18.00 per each A or B share of DKK 1 be paid for the fiscal year 2012. This is a 29% increase compared to the dividend declared for the fiscal year 2011. The AGM is scheduled for March 20, 2013. Full Article
Novo Nordisk A/S' Shares Fall 15% After FDA's Tresiba Response-Reuters
Reuters reported that Novo Nordisk A/S' shares fell 15% after the United States FDA Tresiba response. Full Article
Novo Nordisk A/S Reaffirms FY 2013 Guidance-Conference Call
Novo Nordisk A/S announced that for fiscal 2013, it expects sales growth of 8% to 11% and an operating profit growth of around 10%. The Company reported revenue of DKK 78.026 billion and operating profit of DKK 29.474 billion for fiscal 2012. According to I/B/E/S Estimates, analysts on average are expecting the Company to report revenue of DKK 84.306 billion and operating profit of DKK 30.902 billion for fiscal 2013. Full Article
Novo Nordisk says completes hemophilia drug trial
COPENHAGEN - Denmark's Novo Nordisk, the world's biggest insulin producer, said on Friday it had completed the first phase III trial of a hemophilia drug, N9-GP.
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