Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — Corporate Update (September 2018)
14 slides from Zealand Pharma A/s's corporate update, Sep 19, 2018
Slide 1: Forward-looking statements
Forward-looking statements This presentation contains information pertaining to Zealand Pharma A/S (“Zealand"). Neither Zealand nor its management, directors, employees or representatives make any representation or warranty, express or implied, as to the accuracy or completeness of any of the inform
Slide 2: All primary and key secondary endpoints successfully achieved
All primary and key secondary endpoints successfully achieved 99% of patients on dasiglucagon recovered from low blood glucose within 15 minutes Median time to plasma glucose recovery of 10 minutes with dasiglucagon Primary and key secondary endpoints achieved in pivotal Phase 3 trial with dasigluca
Slide 3: Severe hypoglycemia is one of the most feared complications for diabetes patients on insulin therapy
Severe hypoglycemia is one of the most feared complications for diabetes patients on insulin therapy 1 IDF Diabetes Atlas 8th Edition 2017; 2 American Diabetes Association; 3 cdc.gov and diabetes.org 4 www.diabetesselfmanagement.com/diabetes-resources/tools-tech/insulin-pumps; 5 Kalra 2013, UK Hypog
Slide 4: The glucagon rescue market has substantial value potential
The glucagon rescue market has substantial value potential 1 Estimate based on IMS Health data, 2017 volume of glucagon rescue kit market; 2 IMS Health data, 2017 value, including value from vials used for diagnostic use; 3 2016 U.S. volume (IMS Health) forecasted with an increase in T1D prevalence
Slide 5: ZP4207-16137 Confirmatory Phase 3 trial
ZP4207-16137 Confirmatory Phase 3 trial A phase 3, Randomized, Double-Blind, Parallel Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Rescue Treatment of Hypoglycemia in Subjects with Type 1 Diabetes Mellitus (T1DM) Compared to Placebo and with Reference to GlucaGen® Key Inc
Slide 6: Trial design
Trial design Randomization Hypoglycemic clamp procedure Administration of trial drug 5-hour sampling Randomized, parallel-group, double-blind, phase 3 trial 2:1:1 randomization to a sc single-dose of Dasiglucagon 0.6 mg (n=82) Placebo (n=43) GlucaGen 1 mg (n=43)
Slide 7: Trial endpoints
Trial endpoints Primary Time to plasma glucose recovery Plasma glucose recovery is defined as first increase in plasma glucose of > 20 mg/dL from baseline without administration of rescue IV glucose (censoring at rescue or at 45 min) Key secondary 1-4: Plasma glucose recovery within 30 minutes, with
Slide 8: Glucose recovery with dasiglucagon was 10 minutes with 99% recovered within 15 minutes
Median time to glucose recovery with dasiglucagon was 10 minutes with 99% of patients having recovered within 15 minutes Minutes to plasma glucose recovery Dasiglucagon 82 subj Placebo 43 subj GlucaGen® 43 subj Median (95% CI distribution-free) 10 (10, 10) 40 (30, 40) 12 (10, 12) Log-rank test vs pl
Slide 9: Overall, no safety concerns were raised for dasiglucagon within the trial
Overall, no safety concerns were raised for dasiglucagon within the trial Nausea, vomiting and headache were reported with similar numbers for dasiglucagon and GlucaGen® Dasiglucagon 82 subj Placebo 43 subj GlucaGen® 43 subj Subjects Events Subjects Events Subjects Events Nausea 45 (55%) 46 1 (2%) 1
Slide 10: Conclusions from the pivotal Phase 3 trial
Well-conducted trial with high quality data Met primary endpoint; time to plasma glucose recovery was faster for dasiglucagon than placebo (p<0.001) Median time to plasma glucose recovery: Dasiglucagon 10 min, Placebo 40 min, Glucagen® 12 min 15 min recovery rate: Dasiglucagon 99%, Placebo 2% , Gluc
Slide 11: Competitive landscape for treatment of severe hypoglycemia
Competitive landscape for treatment of severe hypoglycemia For illustration only Glucagon Emergency kit (Eli Lilly)1 Zealand has developed dasiglucagon: a novel stable glucagon analog Fast onset of action Ready-to-use auto-injector pen, no need for reconstitution Stability at refrigerated temperatur
Slide 12: The unique profile of dasiglucagon creates opportunities to target a number of diseases
Novel glucagon analog Unique stability in liquid formulation Fast onset-of-action The unique profile of dasiglucagon creates opportunities to target a number of diseases with high unmet need Dasiglucagon Pump treatment for recurrent low blood glucose, Congenital hyperinsulinism (CHI) – Phase 3 ready
Slide 13: Realizing value in the Zealand pipeline
Dasiglucagon Rare disease Congenital hyperinsulinism Phase 3 initiation Dasiglucagon HypoPal® rescue pen Acute, severe hypoglycemia Phase 3 pediatric trial initiation Dasiglucagon dual-hormone pump Diabetes management Phase 2b initiation Realizing value in the Zealand pipeline Dasiglucagon achieved
Slide 14: Realizing value in the Zealand pipeline
Realizing value in the Zealand pipeline Dasiglucagon achieved primary and secondary endpoints in pivotal phase 3 Met primary endpoint; time to plasma glucose recovery was faster for dasiglucagon than placebo (p<0.001) Median time to plasma glucose recovery: Dasiglucagon 10 min, Placebo 40 min, Gluca