Memorandum

Glucagon Competitive Landscape – July 24, 2019

  • 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 pumps, though we acknowledge that it may be incomplete. We will continuously 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.

Company

Product

Status

Timeline

Xeris

Xerisol (native glucagon stabilized in DMSO-based solvent)

Under FDA Review (PDUFA June 10, 2019)

FDA PDUFA date for Gvoke HypoPen extended to September 10, 2019

 

Five completed studies: multi-site pivotal trial (August 2017)/multi-site pediatric trial (September 2017); G-Pen Mini in treatment of exercise-induced hypoglycemia at the Jaeb Center (February 2017); Phase 3 pediatric trial (ages 2-17); G-Pump Closed-Loop (pumped glucagon for post-bariatric hypoglycemia) proof-of-concept open-loop study at Joslin Diabetes Center (April 2017); G-Pump Closed-Loop for post-bariatric hypoglycemia: Phase 2a RCT with fully closed loop system at Joslin Diabetes Center

 

Ongoing studies: CSI Glucagon for congenital hyperinsulinism; Inpatient proof-of-concept study at Cook Children’s and Texas Children’s (completion expected May 2018); Outpatient proof-of-concept study with fully-automated system at OHSU (sponsored by JDRF)

Lilly

Baqsimi (nasal glucagon)

Approved by FDA; Submitted to EMA

Approved by FDA in July 2019; Under regulatory review in EU as per Lilly's 2Q18 update; Acquired from Locemia; Locemia completed phase 3 studies in adults (ATTD 2015) and pediatrics (EASD 2015; real-world human factors study at EASD 2015; Real-world data at ADA 2017

Zealand

Dasiglucagon (ZP4207)

Phase 3

Phase 3 pivotal trial completed 2Q18; phase 3 immunogenicity trial completed 1Q18 and results expected 2Q18; NDA submission expected in 2019; Positive phase 2a results in Beta Bionics-partnered pump safety study released June 2017 with pivotal phase 2b study planned for 2H18 start; Orphan drug designation in both US and EU for congenital hyperinsulinism

Lilly

Soluble glucagon

Phase 1

Announced in May 2016 R&D update; Candidate is a short-acting, soluble, stable glucagon; Potential use in bi-hormonal closed-loop systems

Novo Nordisk HypoPen 1513 Phase 1 Discontinued 3Q18; Announced in company's 1Q18 earnings update; Phase 1 study expected to complete June 2018

Adocia

BioChaperone Human Glucagon

Phase 1

Phase 1/2 trial to start 4Q18; Positive phase 1 results announced November 2017; Program first announced in June 2016 (for severe hypoglycemia rescue treatment and for use in a dual hormone closed-loop system).

Arecor

Liquid-stable glucagon

Preclinical

Developed prototypes demonstrating stability in syringes and pumps at neutral pH

Latitude

Pumpagon (native glucagon + dextrose)

Preclinical

Currently seeking licensing partner; Preclinical results demonstrate 78% assay recovery at 7 days at body temperature and constant agitation

Latitude

Rescue-G

Unknown

Currently seeking licensing partner; Injectable formulation for hypoglycemia rescue

Windgap Medical

Glucagon autoinjector

Unknown

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

Discontinued Candidates

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.