Category Archives: GLP-1RA

Empa T1DM Filed with FDA; Oral GLP-1RA Advanced to Ph1; Lilly Q2 ’19 Earnings Update

Lilly hosted its Q2 ’19 earnings call and provided updates across its diabetes business. Of note, Lilly’s pipeline now lists empa T1DM as being filed (FDA refused to accept the initial sNDA). Following the 36-week results from Lilly’s AWARD-11 study, Lilly said it plans to file high-dose Trulicity with regulatory authorities “by late 2019.” Furthermore, Lilly’s oral GLP-1RA, called “GLP-1 NPA” (GLP-1 non-peptide agonist), has advanced to Ph1. Below, FENIX provides diabetes-related highlights and insights from the call, including the assumption that the REWIND CHMP agenda listing for July was only for adoption of supplementary information.

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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Sanofi Q2 ’19 Earnings Update

Sanofi hosted its Q2 ’19 earnings call and provided updates to its diabetes business unit including the recent Ph1 initiation for its GLP/GIP/GCG triple agonist (SAR441255). Unsurprisingly, Sanofi did not discuss its recent decision to terminate the Lexicon partnership for sotagliflozin. Below, FENIX provides diabetes-related highlights and insights 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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No Update on REWIND CHMP Decision

A CHMP opinion on Lilly’s REWIND CVOT was anticipated on Friday, July 26; however, there has been no press release from Lilly nor is REWIND listed on the July 2019 CHMP meeting highlights. Below, FENIX provides brief thoughts on the REWIND EU regulatory situation.

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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Sanofi Terminates Partnership with Lexicon for Sotagliflozin Development

In a press release announcing topline results from three Ph3 sotagliflozin T2DM trials, Sanofi disclosed that it is “terminating the collaboration to develop, manufacture, and commercialize Zynquista in all ongoing global type 1 and type 2 diabetes programs.” Following Sanofi’s press release, Lexicon issued its own statement declaring Sanofi’s “notice invalid and Sanofi to be in breach of contract.” Below, FENIX provides initial thoughts and insights about the partnership termination including readthrough to AZ and BI/Lilly.

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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DECLARE Approval Timeline Moved Up; AZ Q2 ’19 Earnings Update

AZ hosted its Q2 ’19 earnings call and provided updates to its diabetes commercial, clinical, and regulatory activities. Importantly, AZ updated the DECLARE US/EU regulatory decision timelines which are now both anticipated in H2 ’19 (previously said to occur in 2020). AZ also disclosed it has a new Ph1 GLP-1RA compound (MEDI7219). Discussion regarding the Farxiga T1DM CRL was minimal. Below, FENIX provides diabetes-related highlights and insights 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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REWIND CHMP Decision This Week; CHMP Agenda Highlights

The CHMP agenda for this week’s meeting has been released, and it includes eight notable items of which Lilly’s REWIND is likely the most significant. Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

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

You can read the article’s full content online after purchase.

Novo Semaglutide Pen Story Continues to Evolve

Novo initiated a Ph1 trial evaluating its new semaglutide injection pen (DV3396) as well as “two different forms of semaglutide” in patients who are overweight or obese. Recall, Novo recently initiated a separate Ph2 trial comparing injection site pain with DV3396 and FlexTouch pens. Below, FENIX provides updated insights regarding the DV3396 injection device based on new information from this Ph1 study.

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 Ozempic Pen Ph2 Trial

A CT.gov record has been observed comparing FlexTouch (PDS290) to the DV3396 pen which appears to be a modified version of the previously studied DV3372 pen (previous FENIX insight). Below, FENIX provides additional insight into Novo’s next-gen semaglutide pen platform.

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.

High-dose Trulicity Topline Results; Jardiance Fast Track Designation for HF

Lilly announced positive topline results from its AWARD-11 study evaluating high-dose Trulicity (3.0 and 4.5mg). Separately, Boehringer Ingelheim and Lilly announced they have received Fast Track designation for the Jardiance heart failure indication based on the ongoing EMPEROR clinical trials. Of note, Lilly did not provide details on the A1C or weight reduction observed in AWARD-11. Below, FENIX provides insight and context on the Jardiance HF Fast Track designation as well as thoughts on AWARD-11 and the potential magnitude of effect with Trulicity 3.0 and 4.5mg doses.

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.

DECLARE CHMP Decision This Week; Sanofi BS-Aspart Filed in EU? CHMP Agenda Highlights

The CHMP agenda for this week’s meeting has been released, and it includes some notable diabetes decisions including AZ’s DECLARE CVOT label update (Type II variation). Additionally, there is a new application for insulin aspart which is believed to be from Sanofi. Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

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.