Memorandum

Glucagon Competitive Landscape – December 29, 2021

  • The table below includes an overview of the soluble glucagon competitive landscape. It includes all the companies we are aware of with glucagon compounds in development for rescue indications or for use in bi-hormonal pumps, though we acknowledge that it may be incomplete. We will continue to update the table as timelines change. Long-acting glucagon formulations under development for weight loss or for co-formulation with GLP-1 agonists can be found in our GLP-1/glucagon dual agonist competitive landscape.
  • We are thrilled to see growing availability and investment in these next-generation glucagons. Such glucagons offer significant improvements in ease-of-use over traditional emergency glucagon kits, which require users to perform a cumbersome reconstitution process prior to usenot an easy task for patients and/or their caregivers in the stress of a hypoglycemic event. We estimate that glucagons currently available from Lilly, Xeris, and Zealand reached approximately $54 million in sales as of 3Q21. We expect the market to continue to grow in the coming quarters, especially as many in the US return to schools, universities, and workplaces. 

Company

Product

Status

Timeline

Xeris

Gvoke (liquid glucagon) in three options:

  1. Kit (single-use syringe + single-use vial)
  2. HypoPen autoinjector
  3. Pre-Filled Syringe (PFS)

Approved by FDA and EMA; HypoPen and PFS launched in US; Ogluo launched in UK

FDA approval of Gvoke Kit in August 2021 with US launch expected early 1Q22

Ogluo (EU trade name for Gvoke) launched in the UK in December 2021, following EMA approval in February 2021; launch in at least seven European countries expected by mid-2022

Gvoke HypoPen launched July 2020 following FDA approval of Gvoke in both the HypoPen auto-injector and prefilled syringe in September 2019

Gvoke PFS launched in November 2019 following FDA approval in September 2019

Results from global phase 3 trial for Gvoke announced in June 2019; phase 3 multi-site pivotal trial vs. Lilly Glucagon presented at ADA 2018; multi-site pediatric trial completed September 2017

Positive topline results from a phase 2 trial evaluating micro-dose ready-to-use Gvoke in exercise-induced hypoglycemia shared in 2020 (published in Diabetes Care); planned IND submission in 1Q22; phase 2 study of G-Pen Mini completed February 2017

In 2Q21 Xeris opted not to advance Gvoke in post-bariatric surgery hypoglycemia despite positive outpatient results announced in May 2020 that replicated 2019 clinical results; Phase 2a proof-of-concept open-loop RCT at Joslin Diabetes Center completed June 2017

Clinical data for Gvoke in bi-hormonal artificial pancreas presented at ADA 2019; Outpatient proof-of-concept study (sponsored by JDRF) at OHSU completed May 2019, though no longer listed on Xeris’ pipeline

Phase 2 inpatient proof-of-concept study of CSI Glucagon for congenital hyperinsulinism completed May 2018

Lilly

Baqsimi (nasal glucagon)

Approved by FDA and EMA

Launched in 3Q19 following FDA approval in July 2019; EMA approval in October 2019 following positive CHMP opinion in 3Q19

New analysis at ATTD 2021; ease of use study presented at AADE 2019; summary of data at ATTD 2018; real-world data at ADA 2017

Acquired from Locemia in 2015; Locemia completed phase 3 studies in adults (ATTD 2015) and pediatrics (EASD 2015; real-world human factors study at EASD 2015

Zealand

Zegalogue (dasiglucagon)

Approved by FDA

US commercial launch in late June 2021 following FDA approval in March 2021

FDA approval based on results from three pivotal trials in adult and pediatric populations, one of which has officially completed, one set to complete in 2H21, and one set to complete in March 2022

Small study at ADA 2021 found quicker, easier administration vs. traditional rescue glucagon; additional study of low-dose dasiglucagon vs. fast-acting carbs at ADA 2021

NDA submitted March 2020 based on completion of phase 3 program, which included a pivotal trial in type 1 adults, a pediatrics trial, and a confirmatory study testing the autoinjector device in adults; phase 2 PK/PD results presented at ADA 2018

Enrollment underway for pivotal phase 3 trial for bi-hormonal iLet; short cross-over RCT presented at ADA 2021; feasibility study published in Diabetes Care in June 2021; FDA Breakthrough Designation in December 2019; Phase 2b trial results announced in June 2019 and read out at FFL 2020; non-inferiority study at ATTD 2018; Positive phase 2a results in June 2017; launch slated for “2022, maybe early 2023”

Orphan Drug Designation in US/EU for congenital hyperinsulinism (CHI); Phase 3 trial in 32 children did not reach primary endpoint, 31/32 patients continued in long-term extension trial; Second phase 3 trial in 12 neonates with CHI underway; completion of phase 3 program expected in 2021

Positive topline results for small phase 2 trial in post-bariatric surgery announced in March 2020

Phase 2 study investigating mini-doses of dasiglucagon for exercise-induced hypoglycemia completed, per update at WCIRDC 2021

Adocia

BioChaperone Glucagon

Phase 1/2

As of 3Q20, Adocia is seeking development and marketing partners and has delayed final phase 1/2 trial initiation from 2H19

BioChaperone Glucagon highlighted at Keystone 2021

Positive phase 1 results announced in 1Q18 and published in Diabetes Care; Program first announced in June 2016

Adocia’s pipeline also lists applications in dual hormone systems, CHI, and post-bariatric surgery hypoglycemia; no specific timelines available[kc1] 

Latitude

Pumpagon (native glucagon + dextrose)

Preclinical

Currently seeking licensing partner; Granted allowance for US patent in January 2019; Preclinical results demonstrate 78% assay recovery at 7 days at body temperature and constant agitation

Windgap Medical

Glucagon autoinjector

Unknown

Currently seeking licensing partner; Estimated three years of development remaining as of October 2017; Uses same dosage as approved glucagon; Must demonstrate bioequivalence

Discontinued Candidates

Lilly

Soluble glucagon

Phase 1

Presumed discontinued December 2021; Not currently listed on pipeline; Announced in May 2016 R&D update; Candidate is a short-acting, soluble, stable glucagon with potential for use in bi-hormonal closed-loop systems

Latitude

Rescue-G

Unknown

Presumed discontinued December 2021; Not listed on pipeline; Injectable formulation for hypoglycemia rescue

Arecor

Liquid-stable glucagon

Preclinical

Presumed discontinued December 2021; Included as one of Arecor’s products in 2019 press release but not listed in current portfolio; Developed prototypes demonstrating stability in syringes and pumps at neutral pH

Novo Nordisk

HypoPen 1513

Phase 1

Discontinued in 3Q18 due to suboptimal PK/PD profile; Phase 1 study completed May 2018; added to the pipeline in 1Q18

Zosano

Transdermal glucagon patch

Phase 2

Phase 2 results announced October 2015; Program suspended April 2016 due to lack of financing.

Biodel

Glucagon Emergency Management (GEM) auto-reconstitution device (BIOD-961)

Phase 1

Phase 1 proof of concept trial completed March 2015; Positive human factors study announced April 2015; Development indefinitely suspended in December 2015 due to contract disputes with manufacturing partner Unilife.