Category Archives: GLP-1RA

Novo’s oral semaglutide beats Jardiance in PIONEER 2

Novo Nordisk has announced topline results from the Ph3 PIONEER 2 study comparing oral semaglutide to BI/Lilly’s Jardiance. Interestingly, this is the second oral semaglutide trial to have topline results (PIONEER 1 FENIX insight); and in each case, Novo has only disclosed on-treatment results. Below, FENIX provides insight into PIONEER 2 results and the impact on oral semaglutide commercialization.

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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AZ Q1 ‘18 Earnings Updates

AZ hosted their Q1 ’18 earnings call and briefly discussed their diabetes portfolio, with a particular focus on Farxiga, including H2 ‘18 readout of the DECLARE CVOT and planned H2 ’18 US filing in T1DM.

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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Thoughts on Novo PRV importance to oral semaglutide

During Novo’s Q1 ’18 London earnings webcast, senior management discussed potential scenarios surrounding the recently-purchased priority review voucher (PRV), including its use for either oral semaglutide or a semaglutide obesity indication. Below, FENIX provides its thoughts on how the PRV serves as insurance to a successful launch for oral semaglutide, as well as some anticipated triggers for its usage.

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 Nordisk Q1 ’18 Earnings Update

Novo hosted its Q1 ’18 earnings call (press release) and provided updates on its marketed and pipeline diabetes products. Of note, Novo discussed the relaunch of Tresiba based on the recent DEVOTE label update. Furthermore, Novo disclosed plans to initiate Ph2 for its QW basal insulin (LAI287) by YE ’18. 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.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

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New Novo CMO?

Novo Nordisk has announced its participation in the Hypo-RESOLVE research project. FENIX has made a curious observation based on the press release, which references Stephen Gough as Novo’s “Global Chief Medical Officer in Denmark.” This position was believed to be held by Alan Moses.

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 Q1 ’18 Earnings Update

Lilly hosted its Q1 ’18 earnings call (press release) and provided updates on its diabetes business unit. Of note, Lilly affirmed REWIND (Trulicity CVOT) topline readout is anticipated in early Q4 ’18 with full results at ADA 2019. 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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Purchase Blast$599.00

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Sanofi’s Head of Global R&D Retiring

Sanofi announced that Elias Zerhouni, the company’s Head of Global R&D, is retiring and will be succeeded by John Reed, the former Global Head of Roche Pharma Research & Early Development.

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 Trulicity High-Dose Ph3 Study (AWARD-11)

A new Ph3 trial (AWARD-11) evaluating 3.0 and 4.5mg Trulicity has been observed on CT.gov. The trial is projected to complete in Q4 ’19. If no additional trials are required, launch could occur as early as Q1 ‘21 (assuming a full 10-month review).

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.

Lexicon Hosts R&D Day

Lexicon hosted its R&D Day and provided an overview of clinical and regulatory activities for its diabetes portfolio including sotagliflozin and LX2761 (selective SGLT1i). Below, FENIX provides highlights of the R&D day as well as thoughts on the impact of sotagliflozin on the T1DM and T2DM markets.

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.

Mylan IR Day Highlights; Biosimilar Victoza and Toujeo in Development

Mylan hosted its Investor Day and provided updates on biosimilar Lantus and Novolog, as well as disclosing for the first time its intentions to develop biosimilar versions of Toujeo, Victoza, and Saxenda. Below, FENIX provides analysis and market implications for each of the biosimilar programs.

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.