Tag Archives: semaglutide

Thoughts on SURMOUNT-MMO after SELECT Interim Analysis

At its Q2 ’22 earnings in August, Novo Nordisk disclosed that SELECT, the Wegovy CVOT, would not stop for overwhelming efficacy at a pre-specified interim analysis (previous FENIX insight). With all the hype now passed, the trial design lens turns to Lilly’s tirzepatide obesity CVOT, SURMOUNT-MMO. Below, FENIX provides thoughts on SURMOUNT-MMO, including Lilly’s potential strategy to get a broad metabolic indication, similar to what BI/Lilly did in HF with Jardiance by eliminating LVEF label language.

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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SELECT Doesn’t Stop at Interim Analysis; Novo Nordisk Q2 ’22 Earnings Update

Novo Nordisk hosted its Q2 ’22 earnings call (press release; slides), which was ahead of the initially scheduled call on August 4. Of note, management disclosed that following an interim analysis, the DMC recommended SELECT CVOT (view CT.gov record) should continue in accordance with the trial protocol. 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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Sema to Replace Metformin as 1L in T2DM?

As a follow-up to Novo’s oral semaglutide ASCEND PLUS primary prevention CVOT being posted to CT.gov (previous FENIX insight), FENIX has conducted an analysis, including thoughts on how Novo may be looking to displace metformin as 1L oral treatment for T2DM.

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 Hosts Wegovy Shortage Call with Investors; Lannett Files Bs-glargine IND; Provention Adds New Management; Intercept NASH Data Delayed

A series of CVRM-related news items have been observed: Novo Nordisk hosted a call with investors to provide additional information and context on the recent announcement regarding its Wegovy supply constraints (view slides); Lannett announced it has filed an IND for its bs-glargine with the pivotal trial to begin in March 2022; Provention Bio announced it has expanded its executive team; and Intercept announced its Ph3 REVERSE trial topline data readout will be delayed to Q1 ’22. 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.

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Purchase Blast$599.00

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Novo Faces New Wegovy Supply Shortage

Novo Nordisk announced it is facing new Wegovy supply challenges in the US, and Novo will not be able to meet demand through H1 ’22. Novo said it will prioritize patients who have already initiated Wegovy treatment. According to the press release, the contract manufacturer has temporarily stopped deliveries and manufacturing due to “issues with Good Manufacturing Practices.” Novo plans to host a call with investors on December 20, 2021 to further discuss the Wegovy supply issue. Below, FENIX provides brief thoughts on the impact to the Wegovy launch.

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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Wegovy Launch Impresses; Guidance Raised; Novo Q2 ’21 Earnings Update

Novo Nordisk hosted its Q2 ’21 earnings call and provided updates across its commercial and pipeline activities, including the ongoing Wegovy and Rybelsus launches and Novo’s intentions to develop and launch an ASCVD or HF product between 2024 and 2028. Of note, the earnings call was previously scheduled for tomorrow (August 5, 2021), but the company curiously moved it up by a day. 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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Wegovy Website Analysis

There have been no cardiometabolic press releases observed yet on the second day of ADA 2021. However, it appears that Novo Nordisk has recently launched the Wegovy patient website. Of note, the HCP website is not yet live as the wegovypro.com URL redirects to NovoMedLink. Below, FENIX provides an analysis of the Wegovy patient website and insights as to when to expect a DTC campaign launch.

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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Wegovy Added to Evernorth Obesity Program; STEP HFpEF DM Trial Observed; JDRF Issues RFA for CGM+Continuous Ketone Monitoring; One Drop Surpasses 25B Data Points

A series of cardiometabolic news items have been observed: Evernorth announced the expansion of its Weight Management Care Value program to include Novo Nordisk’s Wegovy (2.4mg semaglutide); a new Novo-sponsored trial, referred to as STEP HFpEF DM, has been observed evaluating semaglutide in people living with HF, obesity, and T2DM; JDRF issued an RFA for the development of combination CGM + continuous ketone monitoring (CKM) devices for the use of preventing DKA in patients with T1DM; and One Drop announced it has surpassed 25B longitudinal biometric data points in its platform. 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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Wegovy WAC Pricing Analysis

As a follow up to FENIX’s Wegovy label analysis from yesterday, FENIX provides additional thoughts on the Wegovy WAC pricing vs. Saxenda. According to Novo Nordisk’s pricing websites, both Wegovy and Saxenda are being offered at the same WAC of $1,349.02. However, since a 4-pen pack of Wegovy is for 28 days and a five-pen pack of Saxenda is for 30 days, the daily cost of Wegovy is slightly higher than that of Saxenda (see table below). Below, FENIX provides insight on why Novo would offer a premium product near pricing parity with its predecessor.

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.

Wegovy Label Analysis; Novo Investor Event Highlights

Today, Novo Nordisk hosted an investor call following its announcement late Friday (June 4) that FDA approved 2.4mg semaglutide, branded as “Wegovy,” for the treatment of obesity. The approval was based on results from the STEP Ph3a clinical trial program which demonstrated 17% weight loss after 104 weeks with 40% of patients losing ≥20 of their body weight after 104 weeks. Importantly, Novo intends to quickly launch Wegovy starting on June 10, 2021. Below, FENIX provides a Wegovy label analysis including thoughts on Novo’s decision to launch the product in five single-use autoinjector pens.

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.