Tag Archives: Lilly

Trijardy XR (empa/lina/met XR FDC) Approved; Trijardy Label and Market Analysis

Late yesterday, Boehringer Ingelheim and Lilly announced FDA approval for their empagliflozin+linagliptin+metformin XR triple FDC, branded as “Trijardy XR.” Below, FENIX has conducted a Trijardy XR label analysis which includes a comparison to AstraZeneca’s Qternmet XR (dapa+saxa+met XR) as well as thoughts on the potential impact of the triple FDCs on the OAD market segment.

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 Ozempic CV Indication and Rybelsus Data-on-label

Novo Nordisk announced the FDA approval for the Ozempic CV protection indication while Rybelsus only received data-on-label. Recall, Novo separately filed the Ozempic and Rybelsus CV risk reduction indications as a means to mitigate the regulatory risk. Below, FENIX provides thoughts on the new Ozempic indication, insight into why the lack of a Rybelsus CV indication may not really matter in the long run, and readthrough to Lilly (REWIND) and Intarcia (ITCA-650).

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.

JPM 2020 Day 2: LLY, NVO, LVGO, SNY, PODD, ABT, and BD

On the second day of JPM 2020, FENIX has provided coverage of presentations by major diabetes manufacturers including Lilly, Novo Nordisk, Livongo, Sanofi, Insulet, Abbott, and BD. Additionally, Lilly issued a separate press release announcing the addition of Humalog Mix75/25 KwikPen and the Humalog Junior KwikPen to its insulin savings program. Further, Biocorp issued a press release noting a strengthening of the relationship with Sanofi for the Mallya connected pen solution. Below, FENIX provides a topline summary of key takeaways by company followed by more in-depth coverage.

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.

Enrique Conterno’s Retirement Doesn’t Last Long

Fibrogen announced it has appointed Enrique Conterno as its new CEO. Recall, during Lilly’s Q3 ’19 earnings call, the company announced that Conterno would retire at the end of 2019 to be succeeded by Mike Mason. Below, FENIX provides brief thoughts on Conterno’s new role as the head of Fibrogen.

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/UVA Partnership; Roche Decreases Eversense CGM Commitment; Lilly Insulin Pricing Open Letter

A series of diabetes-related news has been observed including a new partnership between Novo Nordisk and UVA, Roche amended its agreement with Senseonics to reduce the minimum CGM volume obligation, and Lilly publishes an open letter on insulin pricing. 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.

Tirzepatide CVOT vs. Trulicity; Lilly 2020 Guidance Summary

Today, Lilly hosted its 2020 Guidance and Investment Community Meeting and discussed potential key milestones for 2020. Importantly, Lilly disclosed that its tirzepatide CVOT will be conducted H2H vs. Trulicity. Below, FENIX provides highlights and insights from the call including thoughts on why a tirzepatide CVOT vs. Trulicity makes sense.

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/Dexcom Updated Partnership for CGM

Lilly announced it has entered into a new agreement with Dexcom to integrate Dexcom CGMs into Lilly’s personalized diabetes management system. Recall, Lilly and Dexcom first entered into their connected care partnership back in 2017, following Lilly’s announcement on its connected ecosystem. Below, FENIX provides potential insights into the updated Lilly/Dexcom 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.

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.

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.