First Quarter 2018 Investor Presentation
Investor Presentation
First three months of 2018
Slide 13
Key development milestones
Diabetes
Obesity
Biopharm
.
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OzempicⓇ granted marketing authorisation by European Commission and approved in Japan
Variation applications for OzempicⓇ submitted to the EMA for the devices and inclusion of SUSTAIN 7 data
New drug application for RyzodegⓇ submitted to the China FDA
XultophyⓇ label to include LEADER and DEVOTE data submitted to the FDA and positive opinion adopted by
CHMP in the EU
DUAL I Japan phase 3a trial with XultophyⓇ completed
LAI287 phase 1 trials completed and phase 2 initiation expected before end of 2018
Development of PI406 to be discontinued following phase 1 results
HypoPen 1513 initiated in phase 1
AM833 phase 1 results completed and phase 2 initiation expected early 2019
N8-GP submitted for regulatory approval in the USA and the EU for treatment of haemophilia A
Phase 1/2 multiple dose trial with subcutaneous N8-GP initiated following completion of single dose trial
Worldwide license to Epi Destiny's sickle cell disease programme (EPI01) obtained
NorditropinⓇ label in the USA updated with two additional indications
changing
diabetes
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