Category Archives: Topics

Updated Perspective on Nemaura’s CGM; Lifescan and Noom Collaboration; Dario Q1 ’20 Earnings Update

Several diabetes-related news items have been observed: Nemaura Medical’s CEO provided an interview regarding the company’s H2H CGM study, saying that the CGM used was Abbott’s Libre, Lifescan announced a partnership with Noom to pilot a digital diabetes and weight loss management program, and DarioHealth hosted its Q1 ’20 earnings call. Below, FENIX provides updated perspective on Nemaura’s CGM in light of the recent CEO interview, thoughts on the Lifescan/Noom collaboration, and highlights from the Dario 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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Thoughts on Yescarta vs Kymriah Q1 2020 Sales Comparison

Yescarta sales continued to grow versus the previous quarter (Q4 2019), seemingly with little initial impact from COVID-19, in contrast to Kymriah which reported a slight dip in Q1 2020 sales (see previous FENIX insight). Below, FENIX provides thoughts on published revenues and possible factors influencing HCPs’ CAR-T prescribing preferences.

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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Gilead/Kite Q1 2020 Earnings Update

On Thursday, April 30, Gilead held their Q1 2020 earnings call (press release / financial report / slides). Of note, Yescarta sales continued to grow versus the previous quarter (Q4 2019), seemingly with little initial impact from COVID-19, in contrast to Kymriah which saw a slight dip in Q1 2020 sales. Below, FENIX provides thoughts on Gilead’s cell therapy program, particularly in the context of the ongoing COVID-19 pandemic.

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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Liso-Cel PDUFA 3-Month Delay; BMS Q1 2020 Call Summary

On Thursday, May 6, BMS held their Q1 2020 earnings call (press release / slides), providing an update on their CAR-T program. As announced on May 5 (press release), the company explained that the liso-cel PDUFA date has been pushed back three months to November 16, 2020 to allow the FDA time to review additional data considered to be a major amendment. Meanwhile, BMS provided brief commentary on their BCMA CAR-Ts ide-cel and orva-cel. Below, FENIX provides highlights and analysis from the call, particularly in the context of the liso-cel PDUFA setback in a field being led by Yescarta and Kymriah.

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.

Nemaura Announces Positive Initial Data from H2H CGM Study; Mylan Q1 ’20 Earnings Update

Two diabetes-related news items have been observed: Nemaura Medical announced positive early data from a H2H trial of sugarBEAT vs. an undisclosed incumbent CGM device and Mylan hosted its Q1 ’20 earnings call. Below, FENIX provides highlights of the news items as well as thoughts on where sugarBEAT may fit within the CGM market.

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.

Ozempic Now Promoted on Victoza HCP Website

Novo Nordisk has recently updated the Victoza HCP website to include messaging for Ozempic. The first image on the Victoza HCP website landing page now states “Consider prescribing once-weekly Ozempic for your appropriate adult patients” with additional Ozempic messaging peppered throughout the Victoza HCP website. As of this publication, there has not been Ozempic messaging added to the Victoza patient website. Below, FENIX provides a brief overview of the Ozempic messaging on the Victoza HCP site as well as thoughts on Novo phasing out Victoza promotion during the COVID-19 pandemic.

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High-dose Trulicity Data (AWARD-11) Published in the Journal of the Endocrine Society

Lilly announced results from the AWARD-11 high-dose Trulicity trial have been published in the Journal of the Endocrine Society, although only the abstract was available at the time of this blast. Interestingly, while both the 3.0 and 4.5 mg dulaglutide doses met statistical significance according to the efficacy estimand analysis, only the 4.5mg dose reached statistical significance for the treatment-regimen estimand analysis. The 3.0mg miss on A1C is in-line with FENIX’s previous hypothesis following Lilly’s AWARD-11 topline announcement in June 2019. Below FENIX provides a brief summary of the AWARD-11 data as found in the Lilly press release.

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

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Insulet Q1 ’20 Earnings Update

Insulet hosted its Q1 ’20 earnings call and provided updates to its diabetes business including the impact of COVID-19 and timing of the Omnipod Horizon launch. Of note, Insulet has filed the updated Horizon algorithm after the company discovered a software anomaly in early March 2020, leading to the trial being put on hold. 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.

Thoughts on Sema NASH Ph2b Data

Novo Nordisk recently announced positive top-line results of its 72-week Ph2b NASH trial for semaglutide. Below, FENIX has conducted a winners-and-losers analysis in the context of Lilly, Sanofi, AZ, BI, and Lexicon, relative to the sema NASH results.

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.

Novo Q1 ’20 Earnings Roadshow; Xeris, Teva, and BD Earnings Updates

Novo Nordisk hosted its post-Q1 ’20 earnings roadshow event. Additionally, Xeris, Teva, and Becton Dickinson held their respective Q1 ’20 earnings calls. Teva did not discuss its generic liraglutide nor did BD discuss the status of its T2DM patch pump. Below, FENIX provides highlights and insights from the respective 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.

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.