Category Archives: SGLT2i

Novartis Discontinues LIK066 in obesity; Novartis and Abbott Q2 ’18 Earnings Updates

Novartis and Abbott both held their respective earnings calls today and provided updates to their respective commercial and pipeline products. Of note, Novartis disclosed it has discontinued development of LIK066 (dual SGLT1/2 inhibitor) for the treatment of obesity. Abbott believes it will be able to reach 1 million global Libre users by YE ’18. Below are highlights from the respective Q2 ’18 earnings calls.

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 CREDENCE

CREDENCE was recently stopped early, bringing a multitude of thoughts and potential implications to the diabetes market. Below, FENIX provides deep, rich analysis on the potential results of CREDENCE, the possibility for CREDENCE to be in a combined FDA review with CANVAS/R, market and label implications, read-through to DECLARE, and how ARB history seems to be repeating itself with SGLT2i.

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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J&J Q2 ’18 Earnings Update

J&J hosted its Q2 ’18 earnings call and provided brief updates on its diabetes business. Importantly, senior management did not make any comments regarding the early stopping of the CREDENCE study or the delay in the CANVAS/R CV indication. Below are highlights from the Q2 2018 J&J earnings 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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Invokana Renal Outcomes Study (CREDENCE) Stopped Early

Janssen announced its Invokana renal outcomes study, CREDENCE, has stopped early for overwhelming efficacy. The trial was stopped early based on the recommendation of the Independent Data Monitoring Committee (IDMC) after a planned interim analysis. The news comes ~3 days after FDA delayed approval of Invokana’s CV safety 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.

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Invokana CV Indication Delayed 3-Months by FDA

Janssen announced FDA has extended the CANVAS/R sNDA review by 3 months with a new action date in October 2018. According to the press release, FDA requested the extension after receiving additional analyses from Janssen. Recall, BI/Lilly had a similar 3-month delay after FDA asked for additional data from the EMPA-REG OUTCOME 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.

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Purchase Blast$599.00

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BI/Lilly Sign Jardiance Outcomes-Based Contract with Highmark

BI/Lilly and Highmark have entered into an outcomes-based contract (OBC) for Jardiance focusing on the “total cost of care for adults with type 2 diabetes and established cardiovascular disease who have been prescribed Jardiance, compared with people who have not been prescribed Jardiance.” Below, FENIX provides insight and context for recent diabetes-related OBCs.

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.

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Purchase Blast$599.00

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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.

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Purchase Blast$599.00

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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.