Category Archives: Glucagon

FENIX Analysis: Baqsimi, Lilly’s Novel Nasal Glucagon Hypo Rescue Product

Recently, Lilly’s novel nasal glucagon hypo rescue product, Baqsimi [BAK-see-mee], was approved by FDA. Below, FENIX provides an in-depth analysis of the Baqsimi label, pricing strategy, and potential market implications for other novel glucagon rescue products from Xeris, Zealand, and Mylan. 

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Lilly Nasal Glucagon Approved As “BAQSIMI”

Lilly’s nasal glucagon has been approved by FDA under the brand name “BAQSIMI”. Recall, during Lilly’s Q1 ’19 earnings call, Lilly announced that FDA delayed the approval by 3 months. FENIX will be conducting an in-depth label analysis in the coming days.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

REWIND CHMP Decision This Week; CHMP Agenda Highlights

The CHMP agenda for this week’s meeting has been released, and it includes eight notable items of which Lilly’s REWIND is likely the most significant. Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Xeris/Insulet Partnership Discontinued? Ph2 Xeris Glucagon Bariatric Surgery Trial

Xeris Pharmaceuticals announced the first patient has been dosed in the Ph2 trial evaluating its ready to use glucagon in patients who experience hypoglycemia after undergoing bariatric surgery (PBH). Xeris previously discussed intentions to initiate this Ph2 trial in a press release from December 2018. Curiously, neither of the press releases nor the CT.gov record makes any reference to delivery via the Insulet Omnipod which had been used in previous Xeris clinical trials with published clinical results. Below, FENIX provides insight into potential reasons why this trial is not using Omnipod.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Xeris Glucagon Ph3 Top-line Data vs. Novo’s GlucaGen

Xeris announced topline results from the fourth Ph3 trial evaluating its stable glucagon formulation for hypoglycemia rescue. This Ph3 crossover study demonstrated that Xeris’s glucagon was non-inferior to Novo’s NovoGen in terms of achieving a plasma glucose >70mg/dL or a ≥20mg/dL increase in 30 minutes following administration. Recall, Xeris recently announced that FDA requested an additional 3 months to review the company’s NDA submission with a new action date on September 10, 2019. Below, FENIX provides brief thoughts on the Ph3 crossover trial in the context of the ongoing Xeris glucagon regulatory review.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

New Sanofi CEO; Xeris delayed: SENS approval, InPen-Dexcom; Zeal-BB; vTv; Adocia

Today, seven major new items were observed across Sanofi, Dexcom/Companion Medical, Xeris, Senseonics, Zealand/Beta Bionics, vTv, and Adocia. Below, FENIX provides context and analysis for the announcements.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Zealand/Beta Bionics Initiate iLet In-home Closed-Loop Trial

Zealand and Beta Bionics announced the first patients have been dosed in Beta Bionics’s iLet in-home closed-loop trial. Recall, during Zealand’s Q1 ’19 earnings call, senior management disclosed that the Ph3 pivotal dual-hormone iLet study is projected to initiate in 2020. Below, FENIX provides an overview of the trial as well as thoughts on the potential market outlook for a dual-hormone closed-loop system and impact on Zealand’s dasiglucagon business.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Zealand Q1 ’19 Earnings Update

Zealand hosted its Q1 ’19 earnings call and provided updates to its diabetes business including dasiglucagon (hypoglycemia rescue, congenital hyperinsulinism, and bi-hormonal closed-loop) and its GLP-1/GCG dual agonist with Boehringer Ingelheim. Recall, Zealand recently disclosed that its dasiglucagon hypoglycemia rescue filing has been delayed to early 2020. Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Zealand’s Dasiglucagon Filing Delayed; Positive Ph3 Dasiglucagon Topline Results

Zealand announced positive topline results for its confirmatory Ph3 hypoglycemia rescue study evaluating dasiglucagon administered via the HypoPal autoinjector. Of note, Zealand also said its FDA filing timeline has been pushed back to early 2020 (previously YE ’19) based on recruitment difficulties with its Ph3 pediatric study. Below, FENIX provides an overview of the Ph3 HypoPal topline results in the context of Zealand’s pursuit of a commercial partner as well as thoughts on the potential impact of the regulatory filing delay.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

ADA 2019 Abstract and Session Titles Available

ADA 2019 abstract and session titles are available through the ADA desktop app. According to the ADA website, full abstract text will be available Tuesday, June 4 at 5:00 pm ET.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.