Category Archives: Topics

Thoughts on Sotagliflozin HF Indication after Entresto’s PARAGON Approval

Last week, Novartis received FDA approval for expanding the Entresto label in HF beyond HFrEF (previous FENIX insight). Ahead of Lexicon’s Q4 2020 earnings later in March, FENIX provides a reminder on the recent sequence of events in HF and thoughts on how the new HF labeling for Entresto could apply to Lexicon’s SGLTi, sotagliflozin.

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 Invests in Danish Facility for Oral Sema Production; MNKD, PRVB, ICPT, BAYRY, and IONS Q4 ’20 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk announced plans to invest 500M DKK (~82M USD) to expand its oral tablet production facilities in Måløv, Denmark; and Mannkind, Provention Bio, Intercept, Bayer, and Ionis hosted their Q4 and FY ’20 earnings call. 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.

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.

Lilly Partners with Welldoc for Connected Pen App

Lilly and Welldoc announced a partnership to integrate Welldoc’s diabetes software solutions with Lilly’s connected insulin delivery ecosystem. According to the press release, the companies will create a new version of Welldoc’s BlueStar app that integrates dosing data from “several of Lilly’s connected insulin pen solutions.” For context, the BlueStar app (view website) includes insulin titration support, a bolus calculator, and personalized health coaching. Below, FENIX provides an overview of the Lilly/Welldoc partnership, including thoughts on how the partnership supports FENIX’s hypothesis that Lilly’s connected pen development is further behind than initially 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.

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.

Tandem and Teladoc Q4 and FY ’20 Earnings Updates

Tandem and Teladoc hosted their Q4 and FY ’20 earnings calls and provided updates on their respective businesses. Importantly, Tandem disclosed that the development of its next-gen t:sport pump platform has been delayed by one quarter. Below, FENIX provides highlights and insights from the respective 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.

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.

Insulet and Esperion Q4 ’20 Earnings Updates

Insulet and Esperion hosted their respective Q4 and full-year 2020 earnings calls and provided updates to their respective businesses. Of note, Insulet disclosed that its Omnipod 5 AID system will be launched in H1 ’21 at price parity to the current Omnipod DASH platform. Below, FENIX provides highlights and insights 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.

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.

Medtronic CY Q4 ’20 (FY Q3 ’21) Earnings Update

Medtronic hosted its CY Q4 ’20 (FY Q3 ’21) earnings call (press release; slides) and provided updates to its diabetes business across the 780G advanced hybrid closed-loop system (AHCL) and next-gen CGM platforms (Zeus and Synergy CGM). Below, FENIX provides highlights and insights from the call, including thoughts on Medtronic’s evolving CGM pipeline.

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.

DAPA-CKD filed with EMA; February 22-25 CHMP Agenda; G&L Partners with IDF

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (February 22-25, 2021) has been released, and it includes one notable item: DAPA-CKD appears for the first time; and Gan & Lee announced a new partnership with IDF. Below, FENIX provides highlights and insights from 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.

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 Health2Sync and SocialDiabetes for Connected Pen Integration

Yesterday, Biocorp announced it has entered two diabetes-related partnerships with Health2Sync (view website) and SocialDiabetes (view website). For context, Mallya turns all disposable insulin pens into a connected device that collects dosing information and sends it to a companion app. Below, FENIX provides thoughts on the new Biocorp partnerships in the context of its existing partnerships (e.g. Roche, WaveForm, and Sanofi).

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.

Tirzepatide Continues to Perform; Positive Ph3 SURPASS-3 and SURPASS-5 Topline Results

Lilly announced positive topline results from the Ph3 SURPASS-3 (vs. degludec) and SURPASS-5 (add-on to glargine U100) trials evaluating the safety and efficacy of three tirzepatide doses (5mg/10mg/15mg). Recall, Lilly announced results from the first Ph3 tirzepatide study, SURPASS-1 (tirzep in treatment-naive patients), in December 2020. According to the press release, the 15mg dose of tirzepatide reduced A1C by -2.4% and weight by -12.9kg in the SURPASS-3 trial. In SURPASS-5, patients observed an average A1C reduction of -2.6% and weight loss of -10.9kg. Full results from SURPASS-3 and SURPASS-5 are scheduled to be presented at ADA 2021 (June 25-29). Below, FENIX provides an overview of the topline SURPASS data as well as updated thoughts on the tirzepatide market impact.

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.

Novartis Wins with Entresto PARAGON-HF FDA Approval

Novartis announced FDA has approved the Entresto sNDA based on results from the PARAGON-HF CVOT (view updated label here). For context, the new indication eliminates the qualifier of HFrEF; however, an additional statement is included, stating the benefit is most clearly evident in patients with LVEF below normal. While the updated label does not include a pure HFpEF indication, it is thought to represent the best-case scenario for Novartis. Below, FENIX provides thoughts on the new Entresto HF indication as well as implications to the evolving HF market, notably Lexicon’s sotagliflozin.

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.