Tag Archives: Novo Nordisk

SUSTAIN FORTE Topline Results: Ozempic 2.0mg Doubles the Dose but not the Efficacy

Novo Nordisk announced topline results from its high-dose injectable semaglutide Ph3 study, SUSTAIN FORTE. The study demonstrated a -2.2% reduction in A1C and -6.9kg weight loss with 2.0mg semaglutide according to the trial product estimand (e.g. per-protocol analysis). Below, FENIX provides a SUSTAIN FORTE comparative analysis, including thoughts on high-dose Ozempic in the context of high-dose Rybelsus, high-dose Trulicity, and tirzepatide, as well as updated perspective on the regulatory timing for Novo’s sema obesity submission with its PRV.

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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FDA Accepts IND for Lilly/Dicerna Cardiometabolic Asset; Gilead/Novo Announce Ph2 PoC NASH Results; Biocorp Launches Mallya in Europe; Nemaura Q3 ’20 Earnings Update; Diabeloop Partners for AID System in Japan

A series of diabetes-related news items have been observed: Dicerna announced FDA accepted Lilly’s IND application for a novel, unknown cardiometabolic asset, LY3561774; Gilead and Novo Nordisk announced positive results from a Ph2 PoC trial evaluating Novo’s semaglutide in combination with Gilead’s investigational FXR agonist and/or its ACC inhibitor for the treatment of NASH; Biocorp announced the launch of its Mallya insulin connected cap in Europe via a partnership with cgmDiabet; Nemaura Medical announced its CY Q3 ’20 (FY Q2 ’21) earnings; and Diabeloop and Terumo Corporation announced a partnership for the joint development of an AID system and exclusive distribution rights in Japan. Below, FENIX provides highlights and insight for the respective news items including curious questions on the Dicerna target split between Lilly-Novo and semaglutide Ph3 combos in NASH.

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 to Acquire Emisphere Technologies; Mylan Q3 ’20 Earnings Update

Two diabetes-related news items have been observed: Emisphere Technologies announced it is being acquired by Novo Nordisk for $1.35B ($7.82/share) and Mylan announced its Q3 ’20 earnings update. Below, FENIX provides thoughts on Novo’s acquisition of Emisphere and potential catalysts behind the acquisition, including oral peptide delivery development beyond semaglutide.

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.

Novo to use PRV for Sema Obesity; Ph1 Glucose-responsive Insulin Trial Initiated; Novo Q3 ’20 Earnings Update

Novo Nordisk hosted its Q3 ’20 earnings call (press release; slides) and provided updates across its pipeline and commercial activities, including the ongoing Rybelus launch, positive ziltivekimab Ph2b topline results, and Ph1 initiation for a novel glucose-responsive insulin. Additionally, Novo disclosed plans to use its PRV for the semaglutide 2.4mg obesity FDA submission. Below, FENIX provides highlights and thoughts from the call, including insight into a hidden importance of using the PRV for the sema 2.4mg obesity filing.

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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Abbott Q3 ’20 Earnings Update; Novo Licenses Antibody Engineering Tech From Chugai

Two diabetes-related news items have been observed: Abbott hosted its Q3 ’20 earnings call (press release) and Chugai licensed its antibody engineering technology to Novo Nordisk (press release). Below, FENIX provides highlights from the respective news items as well as insight into how Novo may leverage Chugai’s antibody technology.

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.

Two New Novo Ph1 QW Icodec Trials

Two new Ph2 trials for Novo Nordisk’s QW insulin icodec have recently been observed on CT.gov, including a PK/PD study evaluating insulin icodec in patients after being run in on insulin degludec (NCT04582435) and a PK study comparing different injection sites (NCT04582448). Both Ph1 icodec trials are scheduled to initiate ahead of the Ph3 program, which is expected to start in November 2020. Below, FENIX provides an overview and thoughts on the two trials, including readthough to Novo’s QW fixed-ratio combination, icosema (icodec+ QW injectable semaglutide).

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 Launches the First Rybelsus Video DTC campaign; New Omnipod DTC from Insulet

Two new DTC commercials have recently been observed: Novo Nordisk launched a Rybelsus video DTC called “Wake Up” and Insulet initiated an Omnipod video DTC called “Simplify Life with Omnipod.” Of note, this is the first Rybelsus video DTC to be observed since the Rybelsus US approval in September 2019. Below, FENIX provides analyses for both of the DTC commercials, including insight into the ongoing Rybelsus 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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New Semaglutide HFpEF Trial (STEP HFpEF); DAPA-MI Posted on CT.gov; Final Day of EASD 2020 (Sept 25)

On the final day of EASD 2020, no new press releases were observed; however, during the Novo Nordisk obesity session, the speaker disclosed plans to conduct a semaglutide HFpEF study. Additionally, AstraZeneca’s DAPA-MI study has been posted on CT.gov. Below, FENIX provides insights and context from the respective news items, including thoughts on why the STEP HFpEF trial appears to fit into the new paradigm of non-outcomes-based label-enabling studies.

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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Dexcom Partners with UVA, Novo CVD Real-world Treatment Study, Movano Partners for Smartwatch CGM; Imeglimin Ph3 Data; EASD 2020 Key Press Releases (Sept 24)

On Day 4 of EASD 2020, four key press releases were observed from Dexcom, Novo Nordisk, Movano, and Poxel. Below, FENIX provides insights and context from each respective announcement, including what could be behind the scenes in the Dexcom-UVA research 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.

New Novo QW Insulin Icodec Data; Novo Updates Rybelsus Website; Dexcom G6 VA Pharmacy Distribution; Ascensia Partners to Accelerate Data Strategy; REWIND Canada Approval; Oramed ORMD-0801 NASH Data; EASD 2020 Key Press Releases (Sept 22)

On Day 2 of EASD, five key press releases and news items were observed from Novo Nordisk, Dexcom, Ascensia, Lilly, and Oramed. Below FENIX provides insights and context from each respective announcement.

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.