Investor Presentation Q1-Q3 2020
67
Investor presentation First nine months of 2020
Once-weekly, biodegradable somapacitan has entered phase 3
for GHD and is approved in the US for AGHD indication
Mean
height velocity
(cm/year)
16
14
12
10
8
6
Phase 2 trial in GHD with 1-year efficacy and safety
*
11.5
10.01
9.7
7.8
Somapacitan
Growth hormone with a
single amino acid
substitution
Albumin binding side
chain securing
reversible binding to
endogenous albumin
4
2
0
0.04
0.08
0.16
0.034
Somapacitan
(mg/kg/week)
Norditropin®
(mg/day)
Next steps
Somapacitan in children (GHD)
• Phase 3 trial (REAL 4) has been initiated
Somapacitan dose 0.16 mg/kg/week
Somapacitan in children (SGA)
• Phase 2 trial (REAL 5) has been initiated
Somapacitan in adults (AGHD)
Has been approved in the US under tradename
Sogroya®
Has been submitted in the EU and Japan
Data are mean height velocity (cm/year) ± SD at week (wk) 52. Doses are mg/kg/time. * Denotes statistical significance difference compared to once-daily NorditropinⓇ. GHD: Growth hormone deficiency; AGHD: Adult-onset growth hormone deficiency; FDA: Food
and Drug Administration; EMA; European Medicines Agency; 'Value was 9.8 for the full analysis set. Value of 10.0 is from a post-hoc analysis that excluded 4 visits of one patient who discontinued prematurely at week 6
Novo Nordisk®View entire presentation