Category Archives: GLP-1RA

FENIX Analysis: Ozempic and Trulicity CV Indication Initial Promotion

Novo Nordisk and Lilly have updated their Ozempic and Trulicity HCP websites with new messaging for their respective CV protection indications. Below, FENIX provides an initial HCP website promotional analysis, which includes insight into how the differences in the respective indications could potentially blur HCP perceptions of the Ozempic and Trulicity brands.

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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CHMP Agenda March 23-26; Lilly Halts Trial Enrollments Over COVID-19 Concerns

The CHMP agenda for this month’s meeting (March 23-26) has been released, and it includes two notable items (high-dose Trulicity Day 120 questions and Biocon/Mylan bs-aspart clock stop extension). Of note, as of the publication of this blast, the March CHMP agenda does not include the “Annex” section, so it is possible that other diabetes-related items are also being reviewed. Separately, Lilly announced it was halting new trial initiation and pausing trial enrollment for most of its clinical studies amid COVID-19 concerns. Below, FENIX provides diabetes-related highlights and insights from the March 2020 CHMP agenda and Lilly announcement.

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 Pfizer Oral GLP-1RA Compound in Ph1

A CT.gov record has been observed for a new Pfizer Ph1 study evaluating multiple escalating oral doses of a novel compound PF-07081532 in T2DM patients and non-T2DM patients with obesity. Below, FENIX provides thoughts on this new trial in the context of oral GLP-1RA pipeline candidates from Pfizer and others.

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.

Thoughts on Intarcia’s Second CRL

The news of Intarcia receiving a second CRL for ITCA-650 (previous FENIX insight) brings about several thoughts and potential market implications. Below, FENIX provides its latest thinking in a favors/disfavors analysis about Intarcia, the GLP-1RA market, and a reminder that others in diabetes have received FDA approval after 2 CRLs.

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.

Intarcia CRL’d again, multiple outlets reporting

Multiple outlets are reporting that Intarcia has received a second CRL for ITCA-650 (see Boston Business Journal and STAT News for articles). FENIX has not seen an official company press release but will continue to monitor.

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.

Intarcia PDUFA passes without update

It has been observed that Intarcia’s March 9 PDUFA date for ITCA-650 has passed. To the best of FENIX’s knowledge, there has been no company announcement from Intarcia and no new NDA database entries seen in an Orange Book search. Recall, after receiving a Sept 2017 CRL, Intarcia re-filed the ITCA-650 NDA on or around September 9, 2019, with a subsequent acceptance announcement on October 8, 2019 (previous FENIX insight). FENIX will provide analysis and market implications once a company announcement is made from Intarcia.

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 Switching Study from other GLP-1RA (SUSTAIN SWITCH)

A new CT.gov record for a high-dose semaglutide switching study (SUSTAIN SWITCH) has been observed. In the study, patients will switch from their existing GLP-1RA therapy (not injectable semaglutide) to subcutaneous QW semaglutide (either 0.25 or 0.5mg starting dose) and titrate up to 2.0mg sema. Below, FENIX provides an overview of SUSTAIN SWITCH as well as insight into how Novo Nordisk may leverage the study to pre-emptively position Ozempic vs. Lilly’s tirzepatide.

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.

CREDENCE CHMP Opinion This Week? DAPA-HF Filed with EMA; CHMP Agenda February 24-27

The CHMP agenda for this month’s meeting (February 24-27) has been released, and it includes two notable items (CREDENCE opinion and DAPA-HF filing) as well as some others. Below, FENIX provides diabetes-related highlights and insights from the February 2020 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.

Lilly REWIND Approved for Primary and Secondary Prevention

Late Friday night, Lilly announced FDA approved the Trulicity CV protection indication based on results from the REWIND CVOT. Trulicity is now the first antihyperglycemic agent to also have a CV risk reduction indication for primary and secondary prevention. Of note, a warning for increased risk of diabetic retinopathy has also been added to the Trulicity label. Below, FENIX provides an analysis of the updated Trulicity label and market implications of the REWIND CV protection indication including readthrough to Ozempic and Rybelsus.

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.

AstraZeneca Q4 ’19 Earnings Update

AstraZeneca hosted its Q4 ’19 and FY ’19 earnings call and provided updates to its diabetes business. Of note, AZ disclosed it received Fast Track designation for the development of cotadutide (dual GLP-1/GCG agonist) for the treatment of NASH. Below, FENIX provides 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.

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.