Category Archives: GLP-1RA

New Tirzepatide vs. Semaglutide Ph1 T2DM Clamp Study; Ph3 SURPASS-1 Monotherapy Trial Initiated

Lilly recently initiated two new tirzepatide T2DM studies. The first is a Ph1 clamp study comparing tirzepatide to Novo’s QW injectable semaglutide, and the second is the Ph3 SURPASS-1 monotheraphy trial vs. pbo. Interestingly, the Ph1 trial is evaluating the effect of tirzepatide on α and β cell function. Below, FENIX provides thoughts on both studies including Lilly’s potential rationale for the H2H clamp trial as well as insight as to why SURPASS-1 is longer than Novo’s Ph3 semaglutide monotherapy trial.

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 oral dual agonist comments @ BAML

Lilly’s president of diabetes, Enrique Conterno, participated in a fireside chat at the 2019 BAML Conference (webcast link here). For what is believed to be the first time, Conterno commented that Lilly is looking to develop an oral GIP/GLP-1 based on its current understanding from tirzepatide (injectable GIP/GLP-1) and having a non-peptidic oral GLP-1RA (OWL833) licensed from Chugai (Ph1 ready; previous FENIX insight).  Below, FENIX provides thoughts on Lilly’s oral GLP-1 development strategy.

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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FDA Issues Final Guidance on Biosimilar Interchangeability

Late last week, FDA issued the final guidance on biosimilar interchangeability titled, “Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry.” Below, FENIX provides thoughts on the FDA interchangeability guidance in the context of the insulin 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.

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FENIX Analysis: GLP-1RA Promotional Materials Post-AACE 2019

In advance of ADA 2019 beginning June 7, FENIX has conducted a comprehensive analysis of new and recent promotional materials obtained at the AACE 2019 conference. In the first installment, FENIX analyzes GLP-1RA promotional materials, to be followed by a separate analysis on SGLT2i, insulin (+GLP-1RA/insulin FRC), and diabetes devices. The GLP-1RA FENIX analysis covers Ozempic, Trulicity, Bydureon, and Victoza.

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.

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.

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Purchase Blast$599.00

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Novo Q1 ’19 London Earnings Update

Novo Nordisk hosted its post-Q1 ’19 earnings event in London. The session included a brief presentation from management followed by Q&A. 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.

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Purchase Blast$599.00

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

Tresiba Hypo Benefit Over Toujeo; Novo Q1 ’19 Earnings Update

Novo Nordisk hosted its Q1 ’19 earnings call (press release) and provided updates to its diabetes business including the recent oral semaglutide and Ozempic regulatory filings. Of note, Novo reported topline results from the Tresiba vs. Toujeo H2H trial. Below, FENIX provides highlights and insights from the call including thoughts on how the Tresiba vs. Toujeo H2H trial may impact the basal insulin 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.

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Merck and Pfizer Q1 ’19 Earnings Updates

Merck and Pfizer hosted their respective Q1 ’19 earnings calls. Both companies only briefly discussed their diabetes-related businesses. Below, FENIX provides highlights from the calls.

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.

REWIND Filed; Empa T1DM, Nasal Glucagon Delayed; Lilly Q1 ’19 Earnings Update

Lilly hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for “technical reasons,” and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 ’19 regulatory events in diabetes.

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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Victoza Pediatric Trial (ELLIPSE) Results and Regulatory Filings

Yesterday, Novo Nordisk presented results from the Victoza T2DM pediatric trial (ELLIPSE) at the Pediatric Endocrine Society/Pediatric Academic Societies annual meeting. Importantly, the results were published in the NEJM, which may be a testament to the growing attention on childhood T2DM/obesity. Additionally, Novo disclosed that it has submitted the data to US and EU regulators, although it did not specify the timing. Below, FENIX provides an overview of the ELLIPSE results – including the non-significant weight loss findings, and thoughts on the study in the context of Victoza’s impending LOE and recent settlement with Teva.

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.