Corporate Presentation
Rare diseases
CHI
Dasiglucagon has potential to address
shortcomings of current management of CHI
Current treatments for CHI are
associated with significant limitations
and clinical barriers
Cited by healthcare providers as greatest limitations5:
•
•
Lack of responsiveness or incomplete response
Adverse effects or intolerable side effects
Treatment
Diazoxide
Glucagon
Somatostat
in analogs
(octreotide)
Pancreatic
surgery
Current usage
(availability varies by country)
• Approved for hyperinsulinism due
to various underlying conditions in
the US and certain ex-US regions²
•
Used off-label in CHI¹
.
• Used off-label in CHI¹
• Short acting: 3-4 daily s.c.
injections/continuous infusion 1.4
Long-acting: intramuscular
injection every 28 days5
• Total/near-total pancreatectomy in
diffuse CHI if medical management
fails 1
•
•
•
.
•
•
.
Clinical barriers
FDA-issued warning on pulmonary
hypertension in infants in 20152,3
Lack of adequate response 1
Hypertrichosis²
Fluid retention, acute heart failure,
pulmonary hypertension²
Requires daily reconstitution of
lyophilized glucagon
Precipitates in the infusion tube
(cannot use long-term)1
Hepatotoxicity 1,4
• Tachyphylaxis, QT prolongation4
Necrotizing enterocolitis (can be fatal
in children with CHI)1,4
Patients develop lifelong insulin
dependent diabetes mellitus5
Patients develop lifelong severe
exocrine insufficiency5
ZEAL&
ZEALAND PHARMA
Dasiglucagon for subcutaneous infusion*
Zealand expects to resubmit Part 1 of NDA related
to three weeks of dosing and Part 2 associated
with chronic use to the US FDA in H1 20247
Glucagon analog designed to allow
for continuous subcutaneous (s.c.)
infusion via pump
Two Phase 3 trials in neonates and
children up to 12 years of age
demonstrated potential in
management of CHI
Wearable s.c. infusion pump system
Nov20กาวในขณ
00003
IP exclusivity: compound patent US 2035 and EU 2039
¹Yorifuji et al. Clin Pediatr Endocrinol 2017;26(3):127-152; 2Proglycem. Package insert. Teva Pharmaceuticals; 2015; ³Gray KD et al. J Perinatol. 2018;38(11):1496-1502; 4Haris et al. Therapeutic Adv Endocrinology Metabolism
2020;11:1-23; 5Zealand Pharma, Physician Market Survey, 2020; 6Zealand Pharma has entered a collaborative development and supply agreement with DEKA Research & Development Corporation and affiliates for infusion pump
system; FDA issued a Complete Response Letter (CRL) to Part 1 of the NDA due to inspection findings at a third-party manufacturing facility that are not specific to dasiglucagon; Part 2 to be supported by additional analyses from
existing CGM datasets included as a secondary outcome measure in the Phase 3 program;
*Investigational compound and device whose safety and efficacy have not been evaluated or approved by the FDA or any other regulatory authority
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