Investor Presentaiton
Investor presentation
First three months of 2017
Slide 99
N9-GP administered once weekly reduces median bleeding
rate to 1.0 episode per year in phase 3 trial
N9-GP phase 1 pharmacokinetics
Paradigm 2 headline results (phase 3)
FIX activity
(IU/mL)
1.2
Dose normalised
rFIX -
pdFIX- N9-GP
• Steady-state half life of 110 hours
•
Median bleeding rate for patients treated on demand was
15.6 episodes per year
•
50 IU/kg (N=15)
1.0
One stage clot assay
0.8
0.6
0.4
0.2
Patients on once-weekly prophylactic treatment had a
medium 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
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
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