Category Archives: Topics

New Oral Sema High-Dose and Flexible Administration Ph1 Trials from Novo

Two new Ph1 trials for Novo Nordisk’s oral semaglutide have been observed on CT.gov. The first Ph1 trial (NCT04524832) is evaluating high-dose oral semaglutide (25mg and 50mg), and the second study (NCT04513704) is comparing flexible administration schedules in terms of the required food restriction. Below, FENIX provides an overview of both trials as well as insight into why each of the trials clearly fit into Novo’s strategy for its GLP-1RA franchise.

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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Biocon/Mylan Launch Semglee in US at 65% WAC Discount to Lantus

Biocon/Mylan announced the US launch of its Semglee 10mL vials and pre-filled pens (glargine U100) at a 65% discount to Lantus. According to Biocon/Mylan, the WAC for a package of 5 x 3mL pens is $147.98 and a 10mL vial is $98.65. Interestingly, Biocon/Mylan said the Semglee pen price matches the Lantus 2007 WAC and the Semglee vial list price matches the Lantus 2010 price. Below, FENIX provides a comparative pricing analysis across the basal insulin market, the Semglee launch implications to Sanofi and Lilly, and thoughts on how the Biocon/Mylan strategy may impact other bs-glargine manufacturers (e.g. Sandoz/G&L and Lannett/HEC).

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 Gilead’s Recent FDA Approval for Tecartus (KTE-X19) in R/R Mantle Cell Lymphoma

On Friday, July 24, Gilead announced (press release) FDA approval of Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only CAR-T treatment for r/r mantle cell lymphoma (MCL). Priority review for Tecartus was based on results from the Ph2 ZUMA-2 trial; a single-arm, open-label study in which 87% of patients responded, with a 62% CR rate. Below, Celltelligence provides manufacturing insights between Yescarta/Tecartus, and how Gilead’s onboarding policy may influence competitors’ future roll-out of additional CAR-T products.

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.

DAPA-CKD Results Highly Positive; AZ Winning in SGLT2i LCM

Full results from the DAPA-CKD renal outcomes trial were presented at the 2020 virtual ESC conference (view AstraZeneca press release), but it does not appear the results have been published. Results demonstrated a highly impressive 39% RRR in the primary composite endpoint (sustained ≥50% decline in eGFR, ESKD, renal death, or CV death). Curiously, the CV death component of the primary endpoint failed to demonstrate a statistically significant benefit (HR=0.81; p=0.20); however, there was a statistically significant 31% RRR in all-cause mortality. Below, FENIX provides thoughts on the DAPA-CKD results in the context of the Invokana CREDENCE study (DKD), the ongoing EMPA-KIDNEY trial from BI/Lilly, and Lexicon’s SOLOIST and SCORED CVOTs.

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.

EMPEROR-Reduced Similarly Positive to DAPA-HF

Full results from the EMPEROR-Reduced HF CVOT were presented at the 2020 virtual ESC conference (view BI/Lilly press release) and published in the NEJM (view publication). Results demonstrated a 25% RRR in the primary composite endpoint (hospitalization for heart failure or CV death), which is consistent with the 26% RRR observed in AZ’s DAPA-HF. Below, FENIX provides thoughts on the EMPEROR-Reduced results in the context of DAPA-HF and the evolving HF landscape.

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.

Lannett To Forego Bs-Glargine U100 Interchangeability; Lannett Q2 ’20 Earnings Update

Yesterday, Lannett (press release) hosted its CY Q2 ’20 (FY Q4 ’20) earnings call and provided updates to its biosimilar glargine U100 development and regulatory plans. Importantly, Lannett disclosed that its bs-glargine U100 strategy is to forego interchangeability and compete as an “affordable alternative.” Below, FENIX provides highlights and insights from the call, including thoughts on Lannett’s strategy as the 5th-to-market bs-glargine U100 in the US.

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.

Medtronic CY Q2 ’20 (FY Q1 ’21) Earnings Update

Medtronic hosted its CY Q2 ’20 (FY Q1 ’21) earnings call (press release; slides) and briefly discussed its diabetes business. Of note, Medtronic rescheduled its Investor Day event for October 14, 2020. 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.

Kymriah Sales Unaffected By COVID-19, but Ph3 Adult ALL Trial Withdrawn; Novartis Q2 2020 Earnings Update

On Tuesday, July 21, Novartis held their Q2 2020 earnings call (press release / financial report / presentation). Of note, Kymriah sales were resilient despite COVID-19, growing +103% WW QoQ and +27% WW versus Q1 2020. Interestingly, the Ph3 OBERON trial investigating Kymriah in adult ALL has been omitted from Novartis’s pipeline. Below, Celltelligence provides thoughts on Novartis’s cell therapy program, particularly surrounding the withdrawal of the Ph3 OBERON study and the ongoing risks posed by competitors, Gilead and Autolus, on Kymriah’s continued sales growth.

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.

Bayer Commits ~$100M in One Drop Series C

One Drop and Bayer announced an updated agreement for the joint development of digital health products in CV, oncology, and women’s health. As part of the agreement, Bayer has led One Drop’s $34.7M Series C funding round and has committed to an additional $64M in development fees and potential commercial milestone payments. Below, FENIX provides thoughts on how One Drop got this far with Bayer, if One Drop took a down round, and some potential irony with Bayer’s focus on diabetes.

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.

One Drop Launches New Membership Program; AZ Partners with RenalytixAI for Chronic Disease Precision Medicine

Two diabetes-related news items have been observed: yesterday, One Drop announced it has launched a new “Digital Membership” platform and AstraZeneca has entered into a partnership with RenalytixAI for “precision medicine strategies” in CV, renal, and metabolic diseases. Below, FENIX provides highlights and insights from the respective news items, including thoughts on why One Drop’s Digital Membership may be an admission that its current diabetes solution and commercial infrastructure is lacking.

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.