Category Archives: Dual/triple agonist

Sanofi Q3 ’18 Earnings Update

Sanofi hosted its Q3 ’18 earnings call (press release) and provided updates on its diabetes and CV business unit including perspective on the recent restructuring announcement (previous FENIX insight). Additionally, Sanofi discussed its 2019 managed care outlook for Lantus, Toujeo, Admelog, and Praluent (PCSK9i). Below are highlights from the call. Financial Highlights Q3 ’18 WW diabetes sales decreased by -9.2% YOY to €1.37B, primarily driven by declining US glargine sales. US diabetes sales for the same quarter also declined by -24.3% YOY to €571M reflecting changes in Medicare Part D (MPD) coverage and declining US glargine net prices. Of note,……

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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Merck Q3 ’18 Earnings Update; No BS-Glargine Discussion

Merck hosted its Q3 ’18 earnings call and only briefly discussed its diabetes business. Of note, this is the first time in recent memory that Merck has provided an accompanying slide presentation with its earnings release. Consistent with previous quarters, nearly all of the event was dedicated to Keytruda, and there was no discussion of Merck’s discontinuation of bs-glargine. Below are highlights from the call.

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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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.

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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.

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Purchase Blast$599.00

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Lilly Dual Agonist Ph3 Analysis; EASD Investor Presentation

Following Lilly’s Ph2b data presentation for its GIP/GLP-1RA dual agonist (LY3298176), the company hosted an analyst call (slides here) to discuss the data. Of note, Lilly outlined its Ph3 development program called “SURPASS” (pictured below) which includes a H2H study vs. semaglutide. Lilly is planning to initiate Ph3 in late 2018 or early 2019 and is projecting global submissions in 2022. Additionally, Lilly disclosed that it will bring the 5, 10, and 15mg doses into Ph3 and will use an auto-injector device. Earlier today, FENIX outlined the LY Ph2b results and provided the potential impact to Novo Nordisk and Sanofi. Below, FENIX conducted a comparative analysis on contemporary Ph3 GLP-1RA pivotal programs, potential rationales behind Lilly’s Ph3 study choices, and how the LY dual agonist is a pipeline-in-a-product similar to Novo’s semaglutide.

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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Lilly Dual-Agonist Shows Impressive A1C and Weight Control, High Rate of GI AEs

Lilly presented results from a Ph2b study evaluating its GIP/GLP-1 dual-agonist (LY3298176) vs. 1.5mg Trulicity, both dosed QW. The results were also published in The Lancet. The trial demonstrated at 26 weeks up to -2.4% reductions in A1C and -11.3 kg weight loss on the highest dose of the LY dual-agonist. Of note, Lilly disclosed plans to initiate Ph3 for LY3298176 “no later than early 2019” with trial completion in 2021. The T2DM Ph3 program will be called “SURPASS,” which seems like it could be a subtle dig at Novo’s injectable semaglutide Ph3 program called SUSTAIN, since Lilly will attempt to surpass semaglutide with its dual-agonist. Additionally, Lilly said it is planning to evaluate the GIP/GLP-1RA in obesity and “…other conditions” (likely NASH). Below, FENIX provides an overview of the LY Ph2b results and their potential impact to Novo Nordisk and Sanofi.

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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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.

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Purchase Blast$599.00

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HARMONY @ EASD: Why You, AZ, and LLY, Should Care

With the upcoming Tanzeum CVOT (HARMONY Outcomes) presentation at EASD 2018 (Tues Oct 2 at 1200pm CET) and in the context of the DECLARE topline results and EXSCEL EU label update for Bydureon (previous FENIX insight), FENIX has conducted an analysis that describes the rationale where by HARMONY Outcomes could act as a potential catalyst for AZ to conduct their next large T2DM CVOT, either as GLP-1RA+SGLT2i or GLP-1/GCG dual-agonist on SGLT2i background therapy. In conjunction, FENIX has conducted a pieces-of-the-puzzle analysis that balances the likelihood HARMONY reads out positive for superiority at EASD.

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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Novo Cuts 400 Jobs in Denmark/China and Confirms Shift in R&D Strategy

Novo Nordisk announced plans to restructure its R&D organization which includes cutting 400 R&D jobs in Denmark and China. Novo is also establishing a new BD unit in Cambridge, MA to help facilitate additional R&D collaborations. This news comes as no surprise and is consistent with FENIX’s previous insight regarding Novo’s shift in R&D strategy as evidenced by 7 external R&D collaborations/acquisitions thus far in 2018. Below, FENIX provides thoughts on Novo’s new R&D 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.

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Purchase Blast$599.00

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New Lilly Academic Collaboration to Help Compete with Novo/Oxford

Lilly and the Indiana Bioscience Research Institute (in collaboration with Indiana University School of Medicine) have partnered to create the “Lilly Diabetes Center of Excellence” (LDCE). According to the press release, the LDCE will support “cutting-edge research in diabetes, diabetic complications, and related metabolic disorders.” Lilly’s decision to create the LDCE appears to be (at least in part) driven by a need to keep up with Novo’s collaboration with The University of Oxford. Below, FENIX provides thoughts on the LDCE including a comparison with a similar program between Novo and University of Oxford.

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.