Category Archives: GLP-1RA

New Sanofi Efpeglenatide + Glargine Study (AMPLITUDE-L)

A CT.gov record has been observed for a new study (AMPLITUDE-L) evaluating Sanofi’s QW GLP-1RA, efpeglenatide, on background insulin glargine. While not specified in the CT.gov record, it is assumed the trial would use Lantus given the “L” in the trial name. Below, FENIX conducted a comparative analysis of the Ph3 efpeglenatide studies in the context of the GLP-1RA class.

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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Novo Partners with Flex for Connected Care Data Management

Novo Nordisk is partnering with Flex to help scale Novo’s diabetes connected care solutions. Interestingly, the press release also disclosed that Flex has already been working with Novo “to help design and manufacture elements of Novo Nordisk’s new connected insulin pens.” According to the press release, Novo has chosen to utilize Flex’s off-the-shelf solution called BrightInsight, which will allow Novo to integrate its apps, connected devices, and algorithms. Below, FENIX provides insight into why Novo’s connected care strategy made a partnership with Flex a necessity despite Novo already having a partnership with Glooko.

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 Ozempic “Real-World Pragmatic Study” with Anthem

Novo Nordisk and Anthem’s outcomes research subsidiary, HealthCore, announced they are working together on a “real-world pragmatic study” (called SEPRA as in SEmaglutide PRAgmatic) evaluating Ozempic vs. standard of care (defined as commercially available oral or injectable antidiabetic medication other than semaglutide). The study initiated in July 2018 and is currently recruiting patients. Below, FENIX provides insight into potential motivating factors for Novo conducting the study (e.g. pilot for an outcomes-based contract).

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.

J&J Q3 ’18 Earnings Update

J&J hosted its Q3 ’18 earnings call but only briefly discussed the Invokana franchise. Senior management did not comment on the CANVAS/R review which is anticipated this month. Recall, in July 2018, J&J announced FDA extended the CANVAS/R sNDA review by 3 months. Below, FENIX provides thoughts on the CANVAS review as well as potential read-through from Lilly’s Ph2b dual agonist results to J&J’s dual agonist, JNJ-64565111.

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

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AZ’s Head of CVRM Joins Novo

Novo Nordisk announced Ludovic Helfgott (pictured below), current global head of AZ’s CV, renal, and metabolism (CVRM), is joining Novo as the Executive VP of Biopharm. According to the press release, Helfgott will join Novo effective April 3, 2019 at which point Jesper Brandgaard, current head of Novo Biopharm and well-known former CFO, will retire. Below, FENIX provides thoughts on Helfgott’s appointment and potential future impact to Novo as well as an analysis of how the Biopharm position could help Helfgott’s career.

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 ADA/EASD Guidelines Recommend GLP-1RA Over Insulin and Make Other New H2H Drug Recommendations

ADA and EASD have updated their T2DM consensus guidelines (journal publication) with notable changes to the framework of the treatment algorithm (pictured below). Now, the algorithm takes a patient-centric approach and suggests a stepwise methodology based on the highest priority for the patient (ASCVD, CKD, hypoglycemia minimization, weight loss, and cost). Importantly, the guidelines recommend the use of GLP-1RA over insulin as the first injectable therapy as well as other in-class H2H drug recommendations. Below, FENIX provides a winners-and-losers analysis, highlights of the guideline updates, and how the identified knowledge gaps may be addressed.

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 Intarcia CMO Fred Fiedorek

Intarcia has a new CMO according to their completely redesigned website. Fred Fiedorek has seemingly replaced Michelle Baron, and this is a big deal. Fiedorak assumes the role of Chief Medical Officer and Global Head of Regulatory Affairs at Intarcia, where he leaves Rhythm Pharmaceuticals in Boston after working on relamorelin and setmelanotide.

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.

HARMONY Superior; REWIND and PIONEER-6 Expectations High

Full results from the albiglutide CVOT, HARMONY Outcomes, have been published in the Lancet and were presented at EASD 2018. As somewhat of a surprise, results demonstrated a 22% RRR in the 3P-MACE primary endpoint (p=0.0006). In a press release, GSK announced the results and disclosed they are “exploring opportunities to divest this medicine to a company with the right expertise and resources to realise its full potential for patients.” Recall, FENIX recently presented a scenario highlighting a strong possibility that HARMONY could show superiority including GSK likely divesting albiglutide for its re-commercialization. Below, FENIX provides perspective on the potential market implications in a winners & losers analysis, as well as who albiglutide suitors are unlikely to 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.

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.

Novo To Layoff 250 US Workers

Novo Nordisk is reportedly cutting 250 US-based jobs. The most recent round of layoffs appears to be part of the June 7 report that Novo was considering cutting 3000 jobs. Recall, on September 18, the company also announced plans to restructure its global R&D organization which included cutting 400 R&D jobs. Below, FENIX provides known details of the US job cuts and an updated headwinds/tailwinds analysis for the ongoing Novo personnel reductions.

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.