Category Archives: Topics

Libre 2 Available for Medicare Patients; Senseonics Receives Positive Medicare Local Coverage Determinations

Abbott announced its Libre 2 CGM system is now available for Medicare patients. Additionally, Senseonics announced that three Medicare Administrative Contractors (MACs) issued Local Coverage Determinations for the use of implantable CGMs. Below, FENIX provides insight into the Abbott and Senseonics Medicare news, including thoughts on how Abbott is more likely to benefit than Senseonics/Ascensia due to the ongoing COVID-19 pandemic.

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AZ Provides Additional DAPA-CKD Commentary During Post-Results Investor Call

Following the DAPA-CKD results, which were presented at ESC 2020 on August 30 (previous FENIX insight), AZ hosted a call with investors (view slides here). Beyond reviewing the DAPA-CKD results, AZ senior management and DAPA-CKD investigators provided commentary on the trial results and the new Farxiga market potential. Below, FENIX provides highlights from the investor call as well as additional perspective on the impact of DAPA-CKD.

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Thoughts on Allogene’s AlloCAR Program; Q2 2020 Earnings Call Summary

On Wednesday, August 5, Allogene held their Q2 2020 conference call (press release / company presentation). The company highlighted presented ASCO data from the ALLO-501 (CD19 allogeneic CAR-T) Ph1 ALPHA study in ≥3L NHL (DLBCL or FL) (Sattva Neelapu et al, May 2020). Management confirmed that the pivotal Ph1/2 ALPHA-2 study of ALLO-501A is underway, with no reported DLTs in the dose level 1 (DL1) cohort. Below, Celltelligence provides key takeaways about Allogene’s CAR-T clinical program, and thoughts on potential hurdles the company may face re-treating patients that have already received Gilead and Novartis’s CAR-Ts in earlier lines of therapy.

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BMS Highlights Ide-cel FDA Re-submission; Q2 2020 Earnings Call

On Thursday, August 6, BMS held their Q2 2020 results (press release / presentation). The company briefly discussed their CAR-T program, highlighting that the BLA for ide-cel in ≥4L RRMM has been re-submitted. In addition, management stated that they look forward to the November PDUFA date for liso-cel in ≥3L DLBCL. Below, Celltelligence provides thoughts on BMS’s two leading CAR-Ts, both of which have experienced delays to their FDA reviews.

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Medtronic’s 770G Pump Approved in Peds Down to 2 Years of Age

FDA has approved Medtronic’s MiniMed 770G hybrid closed-loop system in patients down to 2 years of age (view FDA press release). At the time of this publication, Medtronic had not yet issued its own press release. Recall, the 770G pump uses the same hybrid closed-loop algorithm that is available with the current 670G system, but 770G is BLE-enabled. Below, FENIX provides brief thoughts on the 770G approval.

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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.

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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).

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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.

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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.

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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.

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