Novo Nordisk Investor Presentation - First Nine Months of 2016
Investor presentation
First nine months of 2016
Slide 95
N9-GP administered once weekly reduces median bleeding
rate to 1.0 episode per year in phase 3 trial
N9-GP phase 1 pharmacokinetics
FIX activity
(IU/mL)
1.2
rFIX
One stage clot assay
Paradigm 2 headline results (phase 3)
pdFIX
N9-GP
• Steady-state half-life of 110 hours
.
Dose normalised
50 IU/kg (N=15)
1.0
0.8
0.6
0.4
0.2
0.0
0
24
48
72
96
120
144
168
Time (h)
rFIX: Recombinant factor IX; pdFIX: plasma-derived factor IX
Source: Negrier et al. Blood. 2011;115:2693-2701
changing
diabetes
·
Median bleeding rate for patients treated on demand was
15.6 episodes per year
Patients on once-weekly prophylactic treatment had a
median bleeding rate of 1.0 episode per year when treated
with 40 IU/kg
Among patients receiving 40 IU/kg:
-
99% of bleeding episodes treated with only one infusion
Two thirds of patients experienced complete resolution
of bleeding into target joints
N9-GP appeared to have a safe and well tolerated profile
with no patients developing inhibitors
Next steps
N9-GP Submitted to the European Medicines Agency in
January 2016 and to the US Food and Drug Administration
in May 2016
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