Category Archives: GLP-1RA

New Bydureon label update: EXSCEL now in US label

Earlier this week, the Bydureon franchise label was updated to include 3 major changes: 1) CV safety data from EXSCEL, 2) a worse label restriction at an eGFR <45, up from <30, and 3) inclusion of acute gallbladder disease under warnings. Below, FENIX provides an analysis on the updated Bydureon label in comparison to the SUSTAIN-6 CV data from the Ozempic label, and why AZ may be able to infer in their field promotion that EXSCEL was superior despite the trial’s miss.

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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Connected Pens: Novo Expanded Capability with Glooko; Biocorp/AgaMatrix Partnership

Prior to the start of the 2019 ATTD conference, two diabetes technology-related press releases have been observed. First, Glooko announced that its cloud-storage platform will integrate with Novo Nordisk’s connected pens and Dexcom’s G6 CGM. Second, Biocorp and AgaMatrix entered into a partnership for the distribution of Biocorp’s wraparound connected pen device now called “Mallya” (formerly Easylog). Below, FENIX provides insight into the respective news including thoughts on why the remote upload feature is critical for Novo.

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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Farxiga LCM and Litigation Update; AZ Q4 ’18 Earnings Summary

AstraZeneca hosted its Q4 ’18 earnings call and provided a brief update on its diabetes business including Farxiga LCM initiatives (T2DM CVOT, T1DM, HF, and CKD). Of note, as part of AZ’s business reorganization, MedImmune has been fully integrated including the dissolution of the MedImmune name. Below, FENIX provides highlights and insights from the earnings call including thoughts the generic dapa patent dispute, PDUFA projections for Farxiga T1DM and DERIVE CKD, and AZ’s dual agonist from MedImmune.

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 Discontinues 2 Dual-Agonist Programs; Q4 ’18 Earnings Update

Today, Sanofi hosted its Q4 ’19 earnings call, provided updates to its diabetes business, and disclosed that it discontinued SAR425899 (GLP-1/GCGR) and SAR438335 (GLP-1/GIP) for the treatment of obesity in T2DM and T2DM, respectively. Of note, Sanofi’s CEO will be testifying at the February 26, 2019 Senate Committee hearing on drug pricing. Below, FENIX provides highlights from the call as well as thoughts on Sanofi’s position in diabetes, obesity, and NASH.

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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No REWIND PRV Mentioned; Lilly Q4 ’18 Earnings Update

Lilly hosted its Q4 ’18 earnings call and provided brief updates to its diabetes business including its REWIND outlook, Jardiance tailwinds, URLi regulatory filing, and CAROLINA topline results. Of note, Lilly discontinued development of the Ph2 DACRA-042 compound from KeyBioscience. Below, FENIX provides highlights and analysis 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.

Lilly to use PRV for REWIND? Novo Q4 ’18 London earnings update

Novo Nordisk hosted its post-Q4 ’18 earnings event in London. The session included a brief presentation from management followed by Q&A which primarily focused on Novo’s priority review voucher (PRV) for oral semaglutide. Below, FENIX provides highlights and analysis from the call, as well as the scenario that Lilly could use its PRV for REWIND to keep pace with Novo.

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 File Oral Sema with PRV; Q4 ’18 Earnings Update

Novo Nordisk hosted its Q4 ’18 earnings call and disclosed that it will use its priority review voucher (PRV) for the oral semaglutide US filing by the end of Q1 ’18. Of note, Novo is planning to file for Ozempic and oral semaglutide CV indications based on the results from SUSTAIN 6 and PIONEER 6 despite PIONEER 6 not achieving statistical significance for 3P-MACE. Below, FENIX provides highlights from the earnings call, additional insight on the semaglutide regulatory strategy, and thoughts on why Novo likely wants an oral semaglutide adcom.

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 Renal Outcomes Study (FLOW)

Novo has initiated a new renal outcomes trial for Ozempic called “FLOW.” Below, FENIX provides thoughts on the trial in the context of LEADER (Victoza) and SUSTAIN 6 (Ozempic) results. Additionally, FENIX constructed a renal outcomes comparison table including the GLP-1RA and SGLTi classes.

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 Semaglutide Retinopathy Study Called FOCUS

A new study evaluating the effect of semaglutide on retinopathy in T2DM, called “FOCUS,” has been posted on CT.gov. Recall, data from Novo’s SUSTAIN 6 study showed an imbalance in retinopathy with a 1.76 hazard ratio (50 events with sema vs. 29 with placebo) which resulted in a label warning. Below, FENIX provides details from the study as well as thoughts on how Novo will leverage the data.

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.

Oramed Initiates Ph1 Oral GLP-1RA; Zafgen and vTv Ph2 data

Oramed has initiated its first ORMD-0901 (oral GLP-1RA) Ph1 study under its FDA IND application. Additionally, Zafgen and vTv Therapeutics recently announced data from their respective Ph2 programs for ZGN-1061 (MetAP2 inhibitor) and TTP399 (glucokinase activator). Below, FENIX provides an overview of the Oramed Ph1 study, Zafgen and vTv Ph2 data, and thoughts the viability of each program in the antihyperglycemic market. Oramed Ph1 Oral GLP-1RA initiation Oramed announced the initiation of its first Ph1 study under their FDA IND application. Recall, The IND was granted in September 2018. According to the press release, the Ph1 trial is a randomized, single-blinded crossover……

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.