Tag Archives: NA

Former Lilly Exec Thane Wettig Joins Intarcia As New Head of Marketing

Intarcia announced it has appointed Thane Wettig (pictured below) as the new Chief Marketing Officer and Metabolic Franchise Head.

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 New Sanofi/Verily Connected Care Pre-filled T2DM Pump Partnership

With Sanofi and Verily’s recent Sensile Medical partnership for a connected pre-filled patch pump (Sensile website), FENIX has conducted an analysis of Sanofi’s connected care strategy with market, manufacturing, and payer implications. Below, FENIX provides insight into the diabetes connected care landscape in the context of the large insulin manufacturers (Sanofi, Novo, and 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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EMPA-REG hHF and Renal Data Added to EU Jardiance Label

Boehringer Ingelheim and Lilly announced that Jardiance and its FDCs have received a positive CHMP opinion and label updates for the reduction of hospitalization for heart failure (hHF) and new-onset or worsening kidney disease. Interestingly, the EU label updates are based on data from the EMPA-REG OUTCOME study “due to the current unmet medical need to treat these conditions.” Below, FENIX discusses potential read-through from the precedence set by FDA for previous Pradaxa label updates.

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.

Oral Semaglutide Superior to Januvia at 78 Weeks (PIONEER 3)

Novo Nordisk has announced topline results from the PIONEER 3 study demonstrating superiority in A1C and weight loss at 26 and 78 weeks for 7 and 14 mg oral semaglutide vs. 100 mg Januvia. 3 mg oral semaglutide was statistically significantly inferior to Januvia in A1C. Below, FENIX provides additional insight into oral semaglutide development based on the results from PIONEER 3.

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.

MannKind Re-Initiates TV DTC; Hosts Analyst Meeting

MannKind hosted an Institutional Investor and Analyst Meeting that was largely focused on providing an overview of the company with the intention of attracting new investors. Of note, senior management disclosed that they have re-initiated itsAfrezza TV DTC campaign. Below, FENIX provides highlights of the event including Afrezza EASD data presentations and Afrezza LCM roadmap as well as thoughts on the future for the Afrezza brand.

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.

BI/LLY Ph3 EASE Update – Jardiance in T1DM

Today, BI/Lilly announced positive top-line results for their two Ph3 trials in T1DM, EASE-2 and EASE-3, but they did not provide specific data results in their press release. Curiously enough, Tuesday’s ADA morning session will not be results from the Ph3 EASE trials as BI/LLY said full results from both trials will be at EASD on October 4, 2018. DKA with empa 2.5mg was “comparable to placebo”, and empa 10mg and 25mg DKA rates were “higher than placebo.” BI/LLY said regulatory options are being explored.

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.

“Smart CGM is a new category” – Medtronic ADA 2018 investor event summary

In conjunction with the ADA 2018 congress, Medtronic hosted an investor event (slide presentation) and the diabetes senior management team provided additional insights into their evolving business philosophy beyond the June 5 investor day. Below, FENIX provides a summary of the investor event, which had a large amount of news, as well as analysis behind Medtronic’s deliberate strategic choice to compete near-term in CGM features and solutions vs. hardware convenience.

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.

ADA ’18 Key Data Press Releases (June 24)

4 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs and devices. Below, FENIX has provided context and analysis of these announcements.

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.

Imbalance in DKA Observed in DEPICT-2; Full 52-week inTandem1 data

AZ presented 24-week data from the second Ph3 study (DEPICT-2) evaluating dapagliflozin in T1DM patients, showing an imbalance in DKA compared to placebo. Additionally, Lexicon presented 52-week data of the Ph3 inTandem1 study of sotagliflozin 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.

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 Novo CVOT strategy; ADA ’18 Analyst Briefing

Novo hosted its annual ADA analyst briefing (presentation slides), predominantly discussing oral semaglutide. Of note, Novo disclosed they are no longer conducting a large-scale CVOT for Ozempic (formerly SOUL), instead leveraging the results of both SUSTAIN 6 and PIONEER 6 between injectable and oral semaglutide. Novo senior management said they believe it will be difficult for PIONEER 6 to demonstrate CV benefit at p < 0.05 given the low number of pre-specified events will require a large reduction in the hazard ratio. Additionally, Novo stated they plan to file oral semaglutide in mid-2019. Below are highlights from the ADA analyst event including three potential scenarios for injectable and oral semaglutide CV indications.

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.