Category Archives: Uncategorized

New H2H Tresiba vs. “Lantus” CGM Crossover Study (SWITCH PRO)

A CT.gov record for a new Ph4 T2DM basal-only crossover study (SWITCH PRO) comparing Tresiba (U100) to “Lantus” has been observed. The study was likely named SWITCH PRO because of the crossover design and the use of Abbott’s Libre Pro blinded CGM. Below, FENIX provides thoughts on how Novo could leverage the study to augment its results from the previous SWITCH 1 and SWITCH 2 studies as well as context for the use of time-in-range as the primary endpoint to be first such trial included in the Tresiba label.

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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UPDATED: Lilly Oral GLP-1RA with Chugai

UPDATED: FENIX has included abstract text and the associated poster (download PDF here) that was presented at ADA 2018

Lilly announced it has in-licensed the global development and commercialization rights to Chugai’s non-peptidic GLP-1RA, which is ready to enter Ph1. Below, FENIX provides more details and insight on the deal, especially in the context of Novo’s oral semaglutide. According to the press release, Chugai will receive $50M in an upfront payment and is eligible for undisclosed milestone payments as well as royalties if OWL833 is commercialized.

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.

Roche and Senseonics Expand Partnership

Roche announced it has expanded its partnership with Senseonics to integrate data from the Eversense CGM into Roche’s digital diabetes management solutions (mySugr app and Accu-Chek Smart Pix). According to the press release, the data integration will be available by early 2019. Interestingly, the press release does not discuss what geographies are covered in the partnership expansion. While the Roche/Senseonics commercial partnership is currently limited to Ex-US geographies (Europe, Middle East, and Africa), the expansion of their collaboration could suggest that a US partnership/acquisition is on the horizon. Below, FENIX provides thoughts on how Eversense data integration fits into both companies’ strategies.

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.

Dexcom Acquires TypeZero

Dexcom announced it has acquired TypeZero. Recall, TypeZero developed a proprietary inControl algorithm for insulin dose adjustments. The acquisition is viewed as highly positive for both sides: Dexcom gains future revenue streams and IP while TypeZero investors are able to exit with a presumably attractive return. Below, FENIX provides insight into the acquisition.

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 Launches Rebinyn in the US for People with Hemophilia B

On February 8, 2018, Novo Nordisk officially launched REBINYN, a GlycoPEGylated, Recombinant Coagulation Factor IX, for the treatment of Hemophila B. The BLA for Rebinyn was initially approved on May 31, 2017, and is indicated for on-demand treatment and control of sporadic bleeding episodes and during surgery in adults and children with hemophilia B.

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.