Tag Archives: Lilly

Jardiance EMPERIAL Studies Fail to Show HF Symptom Improvement

Boehringer Ingelheim and Lilly announced that the Jardiance EMPERIAL-Preserved and EMPERIAL-Reduced trials failed to meet the respective primary endpoints. Recall, these trials evaluated the impact of Jardiance on the 6-minute walk test in T2DM and non-T2DM patients with HFpEF and HFrEF. Below, FENIX provides thoughts on the failed EMPERIAL studies in the context of BI/Lilly’s ongoing EMPEROR HF outcomes studies as well as readthrough to AstraZeneca, Janssen, and Lexicon.

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 Ph3 Obesity Program Initiated (SURMOUNT-1)

The first tirzepatide Ph3 obesity study (SURMOUNT-1) has been observed on CT.gov. Below, FENIX provides an overview of the trial, thoughts on the tirzepatide obesity program in the context of Novo Nordisk’s ongoing Ph3 semaglutide obesity program (STEP), and a projection of how far behind Lilly could be.

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 to Invest $400M in Diabetes Manufacturing

Lilly announced plans to invest $400M in its Lilly Technology Center campus in Indianapolis. The capital investment is said to include enhancements to existing manufacturing facilities that make Lilly insulin, expanding capacity for other marketed diabetes products, and initial capital investments for future medicines. Below, FENIX provides brief thoughts on Lilly’s investments including insights into which products are likely benefiting.

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.

New Novo Partnership with Dicerna for RNAi Therapeutics

Novo Nordisk and Dicerna announced a partnership for the discovery and development of RNAi therapeutics targeting liver-related cardio-metabolic diseases including T2DM, NASH, obesity, other chronic liver diseases, and rare diseases. Following the announcement, Dicerna hosted a call with investors to discuss the implications to its business. Below, FENIX provides thoughts on the Novo/Dicerna partnership, particularly in the context of Dicerna’s other existing partnerships including Lilly and Boehringer Ingelheim (separately from the BI/Lilly CV/Met alliance).

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.

New Ph1 LY900027 RAI Compound Could Be For Closed Loop

A Ph1 trial for a new Lilly compound (LY900027) has been observed on CT.gov. Below, FENIX provides thoughts on what the potential MOA could be particularly given the similarity in compound ID with Lilly’s ultra-rapid-acting insulin lispro (URLi), LY900014.

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.

Empa T1DM FDA Adcom Overwhelmingly Negative (2-14); Is SGLTi in T1DM Approvable in the US?

Today, FDA held an advisory committee meeting to discuss the benefit/risk profile of 2.5mg empagliflozin for the treatment of T1DM. Somewhat surprisingly, the panel voted overwhelmingly against (2-14) the approval of 2.5mg empa based on the currently characterized benefit/risk profile and small amount of supporting data. BI/Lilly subsequently issued a press release regarding the outcome of the adcom. Below, FENIX provides insight into the future of SGLTi therapy in T1DM including implications to BI/Lilly, AZ, and Lexicon.

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.

BI/Lilly Initiate Jardiance Acute HF Study (EMPULSE)

BI/Lilly announced the initiation of a new Jardiance study (EMPULSE) in T2DM and non-T2DM patients who have been hospitalized for acute heart failure. Below, FENIX provides an overview of the trial as well as insights into how the EMPULSE trial appears to be a natural progression of BI/Lilly’s Jardiance LCM strategy.

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.

Empa T1DM Adcom Could Be Easier Than Sota, But Still Difficult; Briefing Documents Analysis

Briefing documents for the BI/Lilly empagliflozin T1DM FDA adcom were posted today in advance of the November 13, 2019 meeting. Interestingly, BI/Lilly is only pursuing approval for the low, 2.5mg dose of empagliflozin, which demonstrated less DKA but also lower efficacy. Questions around the 2.5mg dose and its limited clinical data are likely to be the center of the adcom discussion. Below, FENIX provides thoughts on the empa T1DM adcom including analysis of the benefit/risk ratio, proposed risk mitigation strategy, and adcom panelists (9 of whom were also on the sota adcom).

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.

Janssen Partners for Invokana DKD Promotion; BI/Lilly Update Alliance Terms

Janssen and Vifor Pharma announced a US commercial partnership where Vifor will promote Invokana to nephrologists based on the new CREDENCE DKD indication. Additionally, BI/Lilly disclosed plans to “modernize” their current alliance with a focus on the commercialization of Jardiance in T2DM, heart failure, and chronic kidney disease. Below, FENIX provides context and insights surrounding these announcements. Vifor to Target Nephrologists for Janssen’s Invokana Janssen announced a partnership with Vifor Pharma, a global pharmaceutical company with a focus in nephrology, iron deficiency, and cardio-renal therapies. As a part of the agreement, Vifor’s dedicated nephrology salesforce will promote Invokana to nephrologists. Janssen will……

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.

New Lilly Ph1 Trial; Likely GGG Tri-agonist

Lilly has initiated a new Ph1 trial evaluating an unknown compound (LY3437943) vs. Trulicity in T2DM patients. Below, FENIX has conducted an analysis to help identify the compound and potential MOA.

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.