Category Archives: Glucagon

Xeris Glucagon Filed; Q2 ’18 Earnings

Xeris Pharmaceuticals released its Q2 ’18 earnings and disclosed the NDA submission for its Glucagon Rescue Pen. While Xeris did not specify the filing date, it is assumed to have occurred in July or August in accordance with timing from the company’s S-1 document.

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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Novo Q2 ’18 London Earnings Event

Novo Nordisk hosted its post-Q2 ’18 earnings event in London. The format of the event was different than in past quarters. This event started with a short presentation by Novo’s CEO and was followed by a “Meet the Management” session that was not available through webcast. Below are highlights from the available presentation.

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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Glucagon: New Xeris Market Survey Detailed in Investor PPT

Today at 4:30pm ET, Xeris has an investor presentation at the Canaccord Genuity investor conference. In advance of today’s presentation, Xeris posted slides late yesterday from a new August 2018 investor presentation in an SEC filing. The slides disclose the results of a 2018 Xeris-sponsored IPSOS market research study that details what the market’s unmet need is for novel glucagon rescue for severe hypoglycemia. Below, FENIX highlights some of the key results from the IPSOS study, including a slide on novel glucagon competitors that may raise worries about intranasal delivery.

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

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Novo Q2 ’18 Earnings Update

Novo Nordisk hosted its Q2 ’18 earnings call and provided updates to its diabetes and obesity portfolio. Of note, Novo disclosed it will be launching Ozempic in Europe with 3 pens (0.25mg for titration as well as 0.5 and 1.0mg for treatment) as compared to 2 pens in the US. Below, FENIX provides highlights and key insights form 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.

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Purchase Blast$599.00

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New Novo Ph1 Oral Peptide?

A Ph1 CT.gov record for a new Novo drug (NNC0113-2023; NN9023) has been observed. The compound appears to be an oral peptide for multiple reasons including the fact that it uses SNAC, the same gut delivery technology as oral semaglutide. Below, FENIX provides evidence and insight into potential MOAs of the compound.

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

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LLY Dual Agonist Advances to Ph3; Q2 ’18 Earnings Update

Lilly hosted its Q2 ’18 earnings call and provided updates on its marketed and pipeline products. Lilly announced three major pipeline updates including advancement of their QW GIP/GLP-1 agonist to Ph3 after meeting a “high bar” in Ph2 trials, filing of nasal glucagon, and discontinuation of their Ph1 GPR142 agonist. Of further interest, President of Lilly Diabetes, Enrique Conterno, indicated the median follow-up for REWIND would be ~5 years (providing an additional ~1 year for Kaplan-Meier curve separation compared to the 3.8-year median follow-up for LEADER).

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.

Glucagon: Thoughts on Mylan Generic and Novel Launch Timings

The glucagon market for severe hypoglycemia rescue will be evolving in the near future with the anticipated filings of new ready-to-use products from Lilly and Xeris. However, the upcoming Mylan rescue product announced a few months ago will play a significant role in the rescue market ahead of the novel product launches. Below, FENIX provides a rich analysis on the potential timing of the upcoming glucagon rescue entrants from Lilly and Xeris, including also what Mylan’s product may or may not be.

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

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Thoughts on Beta Bionics and Implications to Stable Glucagon, Senseonics, and Fiasp

Beta Bionics has initiated (press release) their home-use clinical trial (CT.gov record)of an insulin-only iLet AP system. Additionally, Ed Damiano, Beta Bionic’s CEO, presented at the Friends For Life conference and provided an update on the iLet commercial device. Below, FENIX provides analysis of the iLet study as well as implications to the glucagon market.

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

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Drug ADA ‘18 Key Data Press Releases (June 23)

21 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs, devices, and apps, a major increase from 9 on the first day of ADA ‘17. Below, FENIX has provided context and analysis for 14 drug-related announcements, with analysis of device and app-related announcements to follow in a separate alert.

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.

Novo Suspends Ph1 Stable Glucagon Analog Study

The CT.gov record for Novo’s Ph1 stable glucagon analog study (NN9030) has been updated, and the trial is now listed as “Suspended (Evaluation of data).” Below, FENIX provides potential scenarios for the recruitment suspension.

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.