Tag Archives: Novartis

CORRECTING AND REPLACING: JPM 2021 Day 1: DXCM, MDT, TDOC, NVS; FDA Accepts EMPEROR-Reduced sNDA Without Priority Review; Adocia to Develop Beta Cell Therapy for T1DM Treatment

On the first day of JPM 2021, FENIX has provided coverage of presentations by major cardiometabolic companies including Dexcom, Medtronic, Teladoc, and Novartis. Additionally, three separate cardiometabolic-related news items have been observed: BI/Lilly announced FDA has accepted the Jardiance sNDA for the reduction of HFrEF in patients with and without T2DM; Dexcom and Teladoc announced the pilot launch of the new “CGM-powered insights” feature for Livongo for Diabetes users; and Adocia filed a patent for cell therapy in patients with T1DM. Below, FENIX provides a topline summary of key takeaways by company followed by more in-depth coverage.

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CRL for Novartis’s Inclisiran (PCSK9i)

Novartis announced it has received a CRL from FDA for the inclisiran NDA. According to the press release, the CRL is not related to efficacy or safety concerns, but rather, it was “due to unresolved facility inspection-related conditions.” Recall, the EC granted marketing authorization for inclisiran on December 11, 2020 (view press release). Below, FENIX provides brief thoughts on the inclisiran CRL.

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Entresto HFpEF Adcom Pre-read Materials Posted

FDA posted the pre-read materials for the upcoming Entresto HFpEF FDA advisory committee meeting on December 15, 2020 (view materials here). As previously stated by FENIX, the outcome of the Entresto adcom is believed to have broad ripple effects throughout the CV/Met market. Below, FENIX provides a brief overview of the key points FDA will consider as well as preliminary thoughts on the adcom.

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Summary of Novartis Meet the Management Investor Event

Today, Novartis hosted its Meet the Management investor event and provided updates to its commercial and pipeline developments. Below, FENIX provides cardiometabolic-related highlights and insights from the event relating to Entresto, inclisiran (PCSK9i), and pelacarsen (LP(a)).

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Kymriah Sales Unaffected By COVID-19, but Ph3 Adult ALL Trial Withdrawn; Novartis Q2 2020 Earnings Update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

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Novartis Ph1b PORTIA Results Presented at Virtual AACR II

On Monday, June 23, Novartis presented (Ulrich Jaeger et al, June 2020) updated clinical data from the Kymriah + pembrolizumab (pembro, a PD-1 inhibitor) Ph1 PORTIA study in ≥3L R/R DLBCL. Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to recent CAR-T + checkpoint inhibitor data from Gilead (Yescarta), BMS (Liso-cel), and Autolus (AUTO3).

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Novartis Discusses Their Activated Rapid Manufacturing Program and Kymriah in the Community Setting

On Monday, June 15, Novartis held an investor call (presentation), highlighting advances to their activated rapid manufacturing (ARM) platform for cell therapy, and their assessment of the community setting for CD19 CAR-T therapies. Below, FENIX provides thoughts on the significance of the ARM platform compared to other rapid manufacturing methods, and the potential impact Kymriah could have outside Centers of Excellence (COE).

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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.

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