Memorandum
The table below includes an overview of the soluble glucagon competitive landscape, with a distinct emphasis on ready-to-use glucagons. It includes all the companies we are aware of with glucagon compounds in development for rescue indications or for use in bi-hormonal pumps. 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 have been thrilled to see growing availability and investment in next generation glucagons over the last several years. 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 use – not an easy task by any stretch of the imagination for patients and/or their caregivers in the stress of a hypoglycemic event. Since the FDA approval of the first “ready-to-use” glucagons in 2019 – Gvoke and Baqsimi - we find it hard to imagine that all payers wouldn’t want all PWD on insulin and sulfonylureas to be using modern glucagon. Indeed, presumably no patients with diabetes would prefer the “old” kits, though some do use them off-label for micro-dosing of glucagon.
- Since the approvals of modern glucagon for Xeris and Locemia/Lilly and, more recently, Zealand, the use of traditional or legacy glucagon kits has continued to decline - seeing Lilly discontinue its traditional glucagon emergency kit in late 2022 was terrific to see for patients. As of earlier this year, according to Xeris’ latest quite valuable March 2023 corporate presentation, ready-to-use glucagons achieved 62% of total US glucagon prescription market share and 75% of new US glucagon prescriptions in February 2023. It’s always terrific to see new prescriptions running ahead of total prescriptions and we’re committed to reporting on this more frequently going forward.
- We estimate that ready-to-use glucagons currently available from Lilly, Xeris, and Zealand brought in revenue of approximately $53 million in 4Q22 – see our 4Q22 glucagon roundup for as complete a picture of the market as we can bring you! We expect to see the market continue to grow in the coming quarters, particularly for Zegalogue following Novo Nordisk’s September 2022 partnership with Zealand, through which Novo Nordisk assumed responsibility for Zegalogue’s commercialization as well as for Baqsimi, which we hope to see receive more focus following Amphastar Pharmaceuticals’s purchase from Lilly, announced today.
|
Company |
Product |
Status |
Timeline |
|
Company |
Product |
Status |
Timeline |
|
Xeris |
Gvoke (liquid glucagon) in three options:
|
Approved by FDA and EMA; HypoPen and PFS launched in US; Ogluo launched in UK |
Xeris discontinued its PFS 0.5 mg per 0.1 mL dosage in January 2023, but the PFS 1 mg per 0.1 mL dosage and all other formulations/dosages remain available Xeris’ European commercialization partner, Tetris Pharma, acquired by Arecor in August 2022, with Arecor obtaining Tetris Pharma’s licensing agreement to commercialize Ogluo in the UK and EU; Tetris Pharma set to launch Ogluo in several additional European companies in 2023 per 3Q22 update Gvoke Kit launched in March 2022 following FDA approval in August 2021 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 Per 2Q22 update, Xeris plans to initiate phase 2 study on ready-to-use glucagon in exercise-induced hypoglycemia in late 2022, though comments from CEO Mr. Paul Edick and absence of mention on 4Q22 update call suggest potential discontinuation of this program; in 2Q21, Xeris opted not to advance micro-dose ready-to-use Gvoke for exercise induced hypoglycemia into phase 3 trials due to extensive clinical requirements set forth by FDA, despite positive topline results from a phase 2 trial 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 |
Lilly divests Baqsimi to Amphastar Pharmaceuticals April 24, 2023 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 Lilly completed negotiation with the Pan-Canadian Pharmaceutical Alliance for Baqsimi in December 2021 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 |
Zealand partnered with Novo Nordisk to commercialize Zegalogue in September 2022 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 |
|
Amphastar |
Glucagon for Injection Emergency Kit, 1 mg |
Approved by FDA and launched in the US |
FDA approved in December 2020 as a biosimilar to Lilly’s Glucagon Emergency Kit, becoming the first approval of a generic glucagon |
|
Adocia |
BioChaperone Glucagon |
Phase 1/2 |
According to Adocia’s January 2023 pipeline summary, the company has put this program on hold and is seeking development and marketing partners 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 |
|
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 |
Discontinued by Lilly in August 2022 and officially removed from the market on December 31, 2022; 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. |
-- by April Hopcroft, Ashwin Chetty, Hanna Gutow, and Kelly Close