Tag Archives: Novo Nordisk

Semaglutide Positive Ph2 NASH Data; Novo Q1 ’20 Earnings Update

Novo Nordisk hosted its Q1 ’20 earnings call (press release; slides) and provided updates to its diabetes business including the ongoing launch of Rybelsus (oral semaglutide) and new Ph2 semaglutide NASH topline data. Unsurprisingly, much of the Q1 ’20 prepared remarks and Q&A were focused on NASH. Below, FENIX provides highlights from the call and additional thoughts on Novo’s PCSK9i/basal insulin hybrid approach.

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 Offers Free Insulin in COVID-19 Response

Novo Nordisk announced plans to give away 90-day supplies of insulin for people who have lost their health insurance due to the COVID-19 pandemic. Below, FENIX provides thoughts on Novo’s response as well as insight into how Novo could be using the program for lead generation and to neutralize biosimilar insulin competition.

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.

FENIX Analysis: Ozempic and Trulicity CV Indication Initial Promotion

Novo Nordisk and Lilly have updated their Ozempic and Trulicity HCP websites with new messaging for their respective CV protection indications. Below, FENIX provides an initial HCP website promotional analysis, which includes insight into how the differences in the respective indications could potentially blur HCP perceptions of the Ozempic and Trulicity brands.

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.

New Ozempic Switching Study from other GLP-1RA (SUSTAIN SWITCH)

A new CT.gov record for a high-dose semaglutide switching study (SUSTAIN SWITCH) has been observed. In the study, patients will switch from their existing GLP-1RA therapy (not injectable semaglutide) to subcutaneous QW semaglutide (either 0.25 or 0.5mg starting dose) and titrate up to 2.0mg sema. Below, FENIX provides an overview of SUSTAIN SWITCH as well as insight into how Novo Nordisk may leverage the study to pre-emptively position Ozempic vs. Lilly’s tirzepatide.

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 Novo GLP-1/GIP Ph1 Trial?

A CT.gov record has been observed for a new Novo Nordisk Ph1 trial evaluating the co-administration of subcutaneous semaglutide and a novel, unidentified compound (NNC0480-0389). Below, FENIX provides an overview of the trial as well as insights as to why NNC0480-0389 is believed to be a GIP agonist.

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.

Positive Topline Novo QW Insulin Results; Novo Q4 ’19 Earnings Update

Novo Nordisk hosted its Q4 and FY 2019 earnings call and provided updates to its diabetes business, including a Rybelsus launch update as well as Ph2 topline results for its QW insulin LAI287 (now called insulin “icodec”). 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.

Rybelsus and URLi Receive Positive CHMP Opinions

Two important positive CHMP opinions were received this week for Novo Nordisk’s Rybelsus and Lilly’s ultra-rapid lispro product (to be branded as Liumjev). Below, FENIX provides thoughts on the positive CHMP opinions including insight into the ongoing US FDA review of Lilly’s URLi.

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.

Thoughts on Ozempic CV Indication and Rybelsus Data-on-label

Novo Nordisk announced the FDA approval for the Ozempic CV protection indication while Rybelsus only received data-on-label. Recall, Novo separately filed the Ozempic and Rybelsus CV risk reduction indications as a means to mitigate the regulatory risk. Below, FENIX provides thoughts on the new Ozempic indication, insight into why the lack of a Rybelsus CV indication may not really matter in the long run, and readthrough to Lilly (REWIND) and Intarcia (ITCA-650).

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.

JPM 2020 Day 2: LLY, NVO, LVGO, SNY, PODD, ABT, and BD

On the second day of JPM 2020, FENIX has provided coverage of presentations by major diabetes manufacturers including Lilly, Novo Nordisk, Livongo, Sanofi, Insulet, Abbott, and BD. Additionally, Lilly issued a separate press release announcing the addition of Humalog Mix75/25 KwikPen and the Humalog Junior KwikPen to its insulin savings program. Further, Biocorp issued a press release noting a strengthening of the relationship with Sanofi for the Mallya connected pen solution. Below, FENIX provides a topline summary of key takeaways by company followed by more in-depth coverage.

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.

JPM 2020 Day 1: DXCM, LVGO, Novo, Bigfoot Biomedical, Companion Medical, MDT

On the first day of JPM 2020, FENIX has provided coverage of presentations by major diabetes manufacturers including Dexcom, Medtronic, Teva, J&J, and Merck. Additionally, four separate diabetes-related news items have been observed including new collaborations between Dexcom/Livongo and Novo Nordisk/Fauna Bio as well as funding rounds from Companion Medical and Bigfoot Biomedical. Below, find a topline summary of key takeaways by company followed by more in-depth coverage.

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.