Category Archives: SGLT2i

JPM 2019 Day 2: LLY, SNY, LXRX, ABT, PODD, MYL

The second day of the 2019 J.P. Morgan Healthcare conference included diabetes-related presentations from Lilly, Sanofi, Lexicon, Mylan, Abbott, and Insulet. Separately, Lilly announced plans to further increase drug pricing transparency using Trulicity TV DTC. The commercials will include a portion directing patients to a Lilly website for more information on list price and average copays. Below, find a topline summary of key JPM takeaways by company followed by more in-depth coverage. In case you missed it, here is a link to FENIX’s Day 1 JPM 2019 insights. Lilly Lilly’s CEO provided a brief introduction to the company and referenced the……

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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JPM 2019 Day 1: DXCM, MDT, JNJ, MRK; New Bigfoot Deal with Lilly

The first day of the 2019 J.P. Morgan Healthcare conference kicked off with diabetes-related presentations from Dexcom, Medtronic, J&J, and Merck. Additionally, Bigfoot announced a non-exclusive license with Lilly for inclusion of Lilly RAI in Bigfoot’s connected care ecosystem and Ascensia entered into an agreement with POCTech for CGM distribution in 13 undisclosed geographies. Also of note, FENIX provides a brief discussion on an early stage CGM company called Glutalor which has David Simmons, former Vice President and Chief Medical Officer at Ascensia Diabetes Care, on the scientific board. Below, find a topline summary of key takeaways by company followed by more in-depth……

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 2019 Guidance Summary

Today, Lilly hosted its 2019 Guidance and Investment Community Meeting and discussed potential key milestones for 2019. Importantly, Lilly announced late stage development plans in obesity and NASH and provided more information on the Ph3 dose titration for its QW injectable GIP/GLP-1 dual agonist tirzepatide. Connected care was also featured, and several comments were made on guidelines updates and new PBM coverage positively affecting Trulicity and Jardiance in 2019. Below, FENIX provides a summary and thoughts on diabetes-related highlights from the event. 

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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Nothing New in Sota Adcom Federal Register Announcement

Today, the FDA published a notice in the Federal Register announcing the sotagliflozin adcom for Jan 17, which was press released yesterday by Lexicon. No notable new details were provided, and the proposed indication is in-line with expectations as “…Adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.”

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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Sotagliflozin Adcom in T1DM Scheduled for January 17, 2019

Today, Lexicon announced that FDA will hold an advisory committee meeting for Zynquista (sotagliflozin in T1DM) on January 17, 2019. This news is in-line with previous guidance from Lexicon’s Q3 ‘18 earnings call. Recall, the PDUFA date for Zynquista is March 22, 2019 (previous FENIX insight). FENIX will provide coverage and analysis of the FDA briefing documents as well as the adcom meeting. The following updates are occurring in the map: Adcom announcement is being added under respective map entries… If you receive our email blasts, you already have an account. Log in nowContext counts when making decisions.Purchase Blast$599.00You can read the article’s full…

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.

Thoughts on New ACC T2DM ASCVD Recommendations

The ACC published their 2018 ACC Expert Consensus Decision Pathway on Novel Therapies for CV Risk Reduction in Patients with T2DM and ASCVD in JACC. Notably, the ACC recommends SGLT2i use for potential CV benefits and GLP-1RA use for those patients who may have an unsuitable risk profile for SGLT2i use. Below, FENIX provides a winners-and-losers analysis based on the recent ACC recommendations compared to the updated ADA/EASD guidelines from October 2018.

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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Invokana CANVAS promotion observed on patient and HCP websites

J&J recently updated the Invokana patient and HCP websites to reflect the recent approval of the Invokana CV indication, i.e., reduction of 3P-MACE from CANVAS/R (previous FENIX insight). Of note, this is the first OAD drug to receive an indication for 3P-MACE risk reduction. Below, FENIX provides additional details on messaging across the SGLT2i class. The updated Invokana patient website indicates that “Invokana is the only type 2 diabetes pill approved to help lower your A1C and reduce the risk of major cardiovascular events including heart attack, stroke, CV death.” The updated promotion depicting a male character doing a heart sign also seems to be new…….

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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Thoughts on the Regulatory Environment in Diabetes

The regulatory environment in diabetes has greatly evolved in the last 10 years since the 2008 FDA CV risk guidance. As recently as ADA and now through EASD in 2018, FENIX considers the regulatory environment in the US and Europe to be highly favorable for sponsors developing diabetes drugs, devices, and technological solutions. Below, FENIX provides its perspective in a winners and losers analysis on how the highly favorable regulatory environment could be positively impactful to the key upcoming 2019 market events in diabetes from sponsors like Lexicon, Sanofi, AZ, Janssen, Novo Nordisk, Xeris, Lilly, BI, Dexcom, Senseonics, Abbott/Bigfoot, Tandem, Insulet, and Medtronic.

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 Disappoints, Yet Creates Many Implications

Results from the Farxiga CVOT, DECLARE, were presented at the American Heart Association conference (AstraZeneca press release) along with a simultaneous publication in the NEJM. Below, FENIX provides thoughts on the many market implications. DECLARE Initial Takeaways and Potential Implications  (In no particular order…) The DECLARE 17% RRR in the composite primary endpoint could be viewed as somewhat underwhelming since there was no CV death benefit, unlike EMPA-REG’s 38% RRR in CV death. Perhaps, though, the 27% RRR in hHF in DECLARE is in the ballpark of RRR based on EMPA-REG and CANVAS/R hHF sub-analyses. At first glance, the DECLARE indication……

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.

Farxiga T1DM US Filing in Q4 ’18; AZ Q3 ’18 Earnings Update

AZ hosted their Q3 ’18 earnings call (press release) and briefly discussed their diabetes portfolio. Of note, AZ disclosed it plans to file Farxiga for a T1DM indication in Q4 ’18. Previously, AZ had been quiet regarding the US Farxiga T1DM filing during Q2 ’18 earnings. Furthermore, full results from the Farxiga CVOT, DECLARE, are being presented at the AHA conference on November 10, 2018. Below, FENIX provides thoughts on the potential DECLARE indication, Farxiga T1DM filing timing, and other highlights from the call. Farxiga CVOT (DECLARE) Filing Given the upcoming DECLARE data presentation at AHA, AZ senior management only……

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.