Tag Archives: Lilly

Lilly Partners with Nimbus Therapeutics for Metabolic Drug Discovery; Arecor Reports Positive Topline Results from Second Ph1 uRAI Trial

Two cardiometabolic-related news items have been observed: Nimbus Therapeutics announced a new partnership with Lilly to develop novel small molecule therapies; and Arecor announced positive topline results from its second Ph1 AT247 trial comparing its ultra-rapid-acting insulin (AT247) to Novolog and Fiasp in T1DM patients. Below, FENIX provides highlights and insights for the respective new 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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Tirzepatide Receives Fast Track Designation in Obesity; Provention Bio and Sanofi Join Forces for Potential Teplizumab US Launch

Two cardiometabolic-related news items have been observed: Lilly announced FDA granted Fast Track designation for the investigation of tirzepatide in adults that are obese or overweight with weight-related comorbidities; and Provention Bio and Sanofi US announced a co-promotion agreement for the commercialization of teplizumab in the US. Below, FENIX provides highlights and insights for the respective new 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

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

Dexcom Expands ex-US G7 Launch; Novo to Initiate OASIS 4 Ph3 Oral Sema Obesity Trial; Lilly to Initiate two Lp(a) Ph2 Trials; Better Therapeutic Publishes BT-001 Pivotal Trial Results in Diabetes Care

Four cardiometabolic-related news items have been observed: Dexcom announced the launch of Dexcom G7 CGM in the UK, Ireland, Germany, Austria, and Hong Kong and hosted an associated pre-recorded streaming event (view here); a Novo-sponsored Ph3 study (OASIS 4) evaluating QD 25mg oral semaglutide in overweight and obese participants has been observed (view CT.gov record); Lilly initiated two Ph2 studies evaluating QD oral LY3453329 (KRAKEN; view CT.gov record) and injectable LY3819469 (view CT.gov record) in adults with elevated Lp(a); and Better Therapeutics announced the publication of 90-day results from its pivotal trial for BT-001, in Diabetes Care. Below, FENIX provides highlights and insights for the respective new 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

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

Tirzepatide Approved in Japan; Nemaura and EVERSANA Partner for BEATdiabetes; SURMOUNT-MMO Trial Record Posted

Three cardiometabolic-related news items have been observed: Lilly announced tirzepatide is approved in Japan (press release); Nemaura announced a preliminary commercialization agreement with EVERSANA for BEATdiabetes (press release); and Lilly’s Ph3 tirzepatide obesity outcomes trial (SURMOUNT-MMO) has been posted on CT.gov (view CT.gov record). 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.

Lilly’s Tempo Smart Button Receives 510(k) Clearance; EASD 2022 Key Press Releases (Sept 21)

On the third day of EASD 2022, three key press releases were observed from Zealand, Carmot Therapeutics, and Abbott. Separately, Lilly’s Tempo Smart Button received FDA 510(k) clearance on September 16, 2022 (view FDA website), although Lilly has not issued a press release. Below FENIX provides insights and context for the respective announcements.

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.

SURMOUNT-MMO Trial Design Presented at EASD 2022

At EASD 2022, Lilly presented a high-level overview of the SURMOUNT-MMO clinical trial design during a session titled “Overcoming challenges in obesity medicine: The SURMOUNT Clinical Development Program” (view session; sign-in required). SURMOUNT-MMO has not yet been posted to CT.gov. Below, FENIX provides an overview of the SURMOUNT-MMO trial design and insights, including key differences with Novo’s SELECT trial.

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.

Tresiba AG vs. Basal Insulin Pricing Analysis

Recently, Novo announced plans to launch an authorized generic (AG) version of Tresiba (insulin degludec) which will be available in the US in Fall 2022 at a 65% discount to the Tresiba branded list price (previous FENIX insight). Below, FENIX has conducted a pricing analysis of the basal insulin market, including insight into how the market dynamics may be shifting.

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.

Akero Becomes a Frontrunner in NASH; Lilly Initiates Tirzepatide Ph2 TREASURE-CKD Trial; Oramed’s Oral Insulin Ph2 NASH Topline Results

Three cardiometabolic-related news items have been observed: Akero announced positive topline results from its Ph2b HARMONY trial evaluating QW efruxifermin (EFX) in pre-cirrhotic NASH (view CT.gov record); Lilly’s Ph2 tirzepatide CKD trial (TREASURE-CKD) has been observed (view CT.gov record); and Oramed announced positive topline results from its Ph2 trial evaluating ORMD-0801 in T2DM and NASH. 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.

FENIX Analysis: Mounjaro Launch Update

Following approval of Lilly’s Mounjaro (tirzepatide) in T2DM in May 2022 (previous FENIX insight), FENIX has conducted an initial launch analysis, including early insights from prescription trends as well as a look into the Mounjaro promotional, sampling, and copay card tactics.

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.

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.

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.