Tag Archives: Novo Nordisk

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.

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.

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.

Novo Partners for HF Cell Therapy

Novo Nordisk and Heartseed announced a global partnership and license agreement for the development, manufacturing, and commercialization of Heartseed’s lead asset HS-001. For context, Heartseed’s lead candidate, called HS-001, is an investigational cell therapy for the treatment of heart failure that uses purified cardiomyocytes derived from induced pluripotent stem cells (iPSC). Below, FENIX provides highlights and insights from the press release.

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.

Novo Resubmits 2.0mg High-dose Ozempic to FDA

Novo Nordisk announced it has resubmitted the sNDA to FDA for QW high-dose 2.0mg injectable semaglutide for the treatment of T2DM. Recall, in March 2021, Novo announced it received a Refusal to File letter from FDA (previous FENIX insight) after initially filing the application on January 20, 2021 (previous FENIX insight). Below, FENIX provides thoughts on the refiling.

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 Obesity Ph2 GGG Tri-agonist Trial; Novo QW Icodec Ph3 T2DM; Sigilon Q1 ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: a CT.gov record for a Ph2 Lilly-sponsored trial investigating QW LY3437943 (GGG tri-agonist) in obesity has been observed; a CT.gov record for Novo Nordisk’s Ph3 QW insulin icodec T2DM trial (ONWARDS 4) has been observed; and Sigilon announced its Q1 ’21 earnings, though it did not provide a development update on SIG-002 nor did it host an associated webcast. 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.

Bigfoot Unity Receives 510(k) Clearance; Bayer’s FIGARO-DKD Meets Primary Endpoint; Viatris Q1 ’21 Earnings Update; Novo Insulin Product Samples Recalled

A series of cardiometabolic-related news items have been observed: Bigfoot announced FDA granted 510(k) clearance for its Bigfoot Unity Diabetes Management System which features connected smart pen caps integrated with Abbott’s Libre 2 CGM; Bayer announced the Ph3 FIGARO-DKD CVOT evaluating finerenone in ~7,400 adults with CKD and T2DM has met its primary endpoint; Viatris hosted its Q1 ’21 earnings call; and Novo Nordisk announced a voluntary recall of 1,468 Levemir, Tresiba, Fiasp, Novolog, and Xultophy product samples due to improper storage temperature conditions. 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 Connected Pen Update; Novo Q1 ’21 Post-earnings Event; Provention Bio, BD, ICPT, and REGN Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly provided an update on its connected pen development, including the disclosure of the Tempo Smart Button (view press release); Novo Nordisk hosted its post-Q1 ’20 earnings event (see previous FENIX insight on Q1 ’21 Novo earnings from May 5); Provention Bio (press release), Becton Dickinson (press release), Intercept (press release; slides) and Regeneron (press release) hosted their respective CY Q1 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items, including thoughts on BD’s decision to spin off its diabetes business.

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.

Novo Nordisk Q1 ’21 Earnings Update

Novo Nordisk hosted its Q1 ’21 earnings call and provided updates across its commercial and pipeline activities, including the ongoing Rybelsus launch, the Ph3 semaglutide 2.4mg NASH trial initiation, and the impending Ph3 trial initiation of high-dose oral semaglutide in obesity. Importantly, Novo disclosed its sales force has primarily been having face-to-face interactions since February 2021. 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.

Heart Failure: Tirzepatide vs. Semaglutide HFpEF Ph3 Trial Analysis

Lilly has recently initiated the Ph3 tirzepatide HFpEF trial, called SUMMIT (view CT.gov record). Recall, during Lilly’s 2021 guidance call (December 15, 2020), Lilly first disclosed plans to develop tirzepatide for the treatment of HFpEF (previous FENIX insight). Below, FENIX provides an overview of SUMMIT, including a comparative analysis with Novo’s semaglutide HFpEF trial (STEP HFpEF).

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.

Ozempic 4-dose Pen Back in the Label; Diamyd to Initiate DIAGNODE-3 Trial “Later This Year”; Nemaura Appoints New Global Head of Digital Programs

A series of diabetes-related news items have recently been observed: Novo Nordisk’s Ozempic label has been updated once again to include an NDC for a 1mg x 4 dose 3mL pen; Diamyd announced a contract with ICON plc for the Ph3 DIAGNODE trial evaluating its Diamyd diabetes vaccine; and Nemaura Medical announced the appointment of Samantha Sanders as Global Head of Digital Programs. Below, FENIX provides highlights and insights for the respective news items, including the curious thoughts on why Novo may have had the 1mg x 4 dose pen removed from the label and added back.

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.