Category Archives: Basal Insulin

Novo Invests in Upgrading Kalundborg Manufacturing Facility

Novo Nordisk announced an investment of DKK 850M (~$135M USD) into expanding its production site in Kalundborg, Denmark. According to the press release, Novo manufactures half of the world’s insulin supply and carries out the assembly and packaging of diabetes and biopharm products at this site. This most recent investment brings Novo’s 2020 Kalundborg investments to nearly $318M USD. Below FENIX provides thoughts on the manufacturing investment in the context of the potential products it could support.

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 ’20 Roadshow; Provention Bio Q2 ’20 Earnings Update; Senseonics Eversense Covered by Highmark

Novo Nordisk hosted its post-Q2 ’20 earnings roadshow event (see previous FENIX insight on Q2 ’20 Novo earnings from August 6). Additionally, Provention Bio hosted its Q2 ’20 earnings call yesterday (press release), and Senseonics announced a positive coverage decision for its implantable CGM from Highmark. Below, FENIX provides highlights and insights from the respective news item and earnings 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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Mylan Filed for Glargine Interchangeability; Insulet, Mylan, and BD Q2 ’20 Earnings Updates

Mylan (press release; slides), Insulet (press release), and Becton Dickinson (press release; slides) hosted their respective Q2 ’20 earnings calls. Of note, Mylan disclosed it has submitted “all necessary documentation to seek biosimilar interchangeability [for Semglee]” as well as a BLA for its bs-aspart with FDA. Below, FENIX provides highlights and insights from the respective earnings 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

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Novo Discontinues its Dual/Triple Agonists for Obesity; Novo Q2 ’20 Earnings Update

Novo Nordisk hosted its Q2 ’20 earnings call (press release; slides) and provided updates to its diabetes, obesity, and NASH clinical and commercial activities, but much of the discussion was focused on Novo’s obesity portfolio. Importantly, Novo disclosed it has discontinued the development of its dual and triple agonists for the treatment of obesity following positive results from the recent semaglutide and AM833 data disclosures (semaglutide Ph3 STEP, Ph2 AM833, and Ph1 sema+AM833). Additionally, FENIX includes context from Novo’s invite-only R&D event on June 19 (view slides here). Below, FENIX provides highlights and insights from the call, including why it makes sense Novo would use its PRV for semaglutide in obesity.

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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Lilly Initiates New Connected Pen Trial

A CT.gov record has recently been observed for a Lilly-sponsored trial evaluating the user experience of its “integrated insulin management” system (IIM) in both T1DM and T2DM adult patients. According to the CT.gov record, the IIM system is comprised of lispro and/or glargine pens, a mobile medical application (MMA), a BLE insulin data transmission (IDT) module, and a commercially available BLE-enabled BGM. Below, FENIX provides an overview of the trial as well as thoughts on how it could indicate Lilly is further behind in its connected pen ecosystem development than originally thought.

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.

EMPEROR-Reduced Positive Topline Results; AZ Discontinues its GLP-1RA Small Molecule; Lexicon to Reorganize; Lilly, AZ, and Lexicon Q2 ’20 Earnings Updates

Lilly (press release; slides), AstraZeneca (press release; slides), and Lexicon (press release; slides link unavailable) hosted their respective earnings calls. Importantly, BI/Lilly announced positive topline results from the EMPEROR-Reduced outcomes trial in HFrEF patients with and without T2DM, AZ discontinued its small molecule GLP-1RA (MEDI7219), and Lexicon is restructuring its business to shift focus toward R&D. Below, FENIX provides insights into the EMPEROR-Reduced results in the context of the evolving SGLT2i HF market as well as thoughts on how Lexicon’s restructuring could be an indicator for the sotagliflozin CVOT results.

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.

Sanofi Q2 ’20 Earnings Update

Sanofi hosted its Q2 ’20 earnings call (press release; slides) and provided a brief update to its diabetes business in the context of the continued decline in glargine revenue. Unsurprisingly, the vast majority of the call was dedicated to Dupixent performance and Sanofi’s preparation for the upcoming flu season. Below, FENIX provides a financial summary of the diabetes portfolio 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

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Biocon Levels-up Insulin Strategy – Biocon CY Q2 ’20 Earnings Update

Biocon hosted its CY Q2 ’20 earnings call (FY Q1 ’21) and provided updates to the business including its biosimilar insulins portfolio (view press release). Of note, Biocon Biologics CEO Christiane Hamacher commented that the recent Voluntis “…digital therapeutic is not a nice to have, it’s a must-have.” Below, FENIX provides an updated perspective on the Biocon/Voluntis partnership, including thoughts on how the partnership may signal that Biocon could have altered its bs-insulin 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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Purchase Blast$599.00

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Lexicon Reports Remaining Topline Ph3 Sota T2DM Results; Biocon Partners with Voluntis For Digital Insulin Solution

Two diabetes-related news items have been observed: Lexicon reported topline results from the four remaining sotagliflozin T2DM Ph3 trials and Biocon partnered with Voluntis to integrate Biocon bs-insulins with Voluntis’s Insulia automated dose calculator. Below, FENIX provides thoughts on the Lexicon Ph3 sota T2DM data in the context of the company’s decision not to move forward in T2DM without a strategic partner as well as potential insight into the Biocon/Voluntis partnership.

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.

High-dose Trulicity CHMP Opinion this week?; CHMP Agenda July 20-23

The CHMP agenda for this month (July 20-23) has been released, and it includes one notable item, a potential high-dose Trulicity CHMP opinion, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the July 2020 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.

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.