Category Archives: Insulin Delivery

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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Dexcom Partners with Current Health for Remote Patient Monitoring; Nemaura to Integrate with Activity Trackers; Roche Q2 ’20 Earnings Update

Three diabetes-related news items have been observed: Dexcom has partnered with Current Health for remote patient monitoring, Nemaura announced it will integrate activity tracker data into its proBEAT app and Roche hosted its Q2 ’20 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items.

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.

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Purchase Blast$599.00

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

IQVIA/JDRF Partner for T1DM Research; MannKind Hires Former Medtronic Exec as CCO; Insulet Initiates Horizon Preschool Trial; Adocia Q2 ’20 Earnings; Dario Partners for UK Distribution

A series of diabetes-related news items have been observed including: IQVIA and JDRF are collaborating to use real-world data to better understand T1DM, MannKind announced Alejandro Galindo (former head of Medtronic’s automated insulin delivery business) is joining the company as the new CCO, Insulet initiated a new Omnipod Horizon trial in preschool-aged children (view CT.gov record), Adocia released its Q2 ’20 earnings (view press release; a webcast was not held), and Dario Health has partnered with Williams Medical for UK distribution. Below, FENIX provides highlights and insights for the respective news items, including why the IQVIA-JDRF partnership is interesting to manufacturers of CGM systems and insulin products.

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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Tandem and Medtronic Enter Into “Non-exclusive Patent Cross-license Agreement”

Tandem and Medtronic announced they have entered into a “non-exclusive patent cross-license agreement” for existing and new products and services relating to each companies’ diabetes portfolio; however, there are certain undisclosed exclusions. According to the press release, no payments are being exchanged, and additional terms of the deal are not being disclosed. Below, FENIX provides thoughts on this curious agreement in the context of Tandem’s recent win with UnitedHealthcare (previous FENIX insight).

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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First Libre 3 Clinical Study Initiated

A CT.gov record has been observed for what is believed to be the first Abbott Libre 3 clinical trial. Abbott publicly disclosed the existence of Libre 3 during its Q1 ’19 earnings call (previous FENIX insight). Recall, the Libre 2 CGM was recently approved in the US, but its use with integrated systems is limited due to Vitamin C interference (previous FENIX insight). There is no mention of Vitamin C in the Libre 3 CT.gov record. Below, FENIX provides an overview of the new Libre 3 study as well as potential insight into the timing of its initiation in the context of the Libre 2 US label restrictions.

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.

Tandem Partners with JDRF for Diabetes Device Education Campaign; Livongo’s myStrength App Available for Free to Priority Health Members

Two diabetes-related news items have been observed: Tandem announced it is partnering with JDRF for a national T1DM educational awareness campaign focusing on diabetes technology and Priority Health is providing Livongo’s myStrength mental health app for free to its members. Below, FENIX provides insights into the respective news items, notably the timing of the Tandem/JDRF collaboration given the recent favorable reimbursement decision by UnitedHealthcare (previous FENIX insight).

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.

UnitedHealth to Cover Tandem Pumps

Several equity research analyst sources are reporting UnitedHealth Group is now covering Tandem’s insulin pumps (view article here). Although an official policy document from UnitedHealth (UNH) could not be found in a timely manner, FENIX provides brief thoughts on the United coverage in the context of the previous exclusive agreement between United/Medtronic as well as Tandem’s recent FDA pediatric approval for Control IQ.

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.

Biocorp Partners with Roche in France for Mallya Distribution

Biocorp announced it has signed an agreement with Roche Diabetes Care France for the distribution of Biocorp’s Mallya device in France. Recall, Mallya turns any disposable or reusable insulin pen into a connected device that collects dosing information and sends it to a companion app. Below, FENIX provides thoughts on the Biocorp/Roche partnership in the context of Biocorp’s other partnerships, notably Sanofi, WaveForm (formerly AgaMatrix), and DreaMed.

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.

Abbott/Tandem Finalize AID Partnership; What is Tandem’s Role?

Abbott and Tandem Diabetes Care announced the finalization of an agreement for the two companies to develop and commercialize “integrated diabetes solutions.” Recall, the companies first announced their intention to work together in October 2019 (previous FENIX insight). Below, FENIX provides thoughts on the partnership, including potential insight into how Abbott may be leveraging the Tandem partnership to deal with the Libre 2 Vitamin C interference issue.

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.