UPDATED – Entresto HFpEF Adcom: 12-1 Positive Vote, but End Result Remains Confusing
Content now updated with the Q1 2021 PDUFA date announced in the post-adcom Novartis press release.
Content now updated with the Q1 2021 PDUFA date announced in the post-adcom Novartis press release.
A series of diabetes-related news items have been observed: Lifescan announced the launch of its OneTouch Store which includes subscription offerings for live diabetes coaching services accessible through the OneTouch Reveal app; Welldoc announced the submission of its 510(k) filing with FDA to expand its insulin dosing support to include bolus and premixed insulin titration for users with T2DM; Biocon/Viatris (Mylan) announced the companies received a positive CHMP opinion for their bs-insulin aspart; and Poxel announced additional results from its Ph2a study of PXL770 in NASH. Below, FENIX provides highlights and insights for the respective news items.
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.
A series of diabetes-related news items have been observed: earlier this week, Procyon Technologies LLC announced it has entered into a partnership with Novo Nordisk for the development of an implantable cell encapsulation device to be combined with Novo’s stem cells for the treatment of T1DM; Bigfoot Biomedical announced new hires within the company to build out its commercial team ahead of the Bigfoot Unity US launch; JDRF and Provention Bio announced the launch of T1Detect, a T1DM screening campaign; a clinical trial has been observed for AT278, Arecor’s ultra-concentrated rapid-acting insulin aspart; and City of Hope announced enrollment has opened for a Ph1 T1DM vaccine trial. Below, FENIX provides highlights and insights for the respective news items.
Lilly announced topline results from the first tirzepatide Ph3 study, SURPASS-1. The study demonstrated up to a -2.1% reduction in A1C and -9.5kg weight loss with 15mg tirzepatide, according to the trial product estimand (e.g. per-protocol analysis). Full results from the SURPASS-1 trial are scheduled to be presented at the ADA 2021 conference (June 25-29). Of note, Lilly has also recently initiated three additional Ph3 studies in the tirzepatide obesity program (SURMOUNT 2, 3, and 4). Below, FENIX provides a SURPASS-1 comparative analysis, including thoughts on tirzepatide in the context of high-dose Ozempic, high-dose Rybelsus, and high-dose Trulicity.
Yesterday, Ionis hosted its 2020 Investor Day event and provided updates to its pipeline developments, including its PCSK9i that has been licensed to AstraZeneca (ION449/AZD8233). Importantly, Ionis provided details on the discontinuation of its oral formulation of the AZ PCSK9i in favor of a next-gen version. Below, FENIX provides cardiometabolic-related highlights and insights from the event.
Virta Health announced it raised $65M in a Series D funding round led by Sequoia Capital Global Equities and Caffeinated Capital which values Virta Health at >$1.1B. For context, Virta offers non-pharmaceutical coaching and lifestyle intervention program for chronic metabolic conditions, including T2DM, with the goal of improving patient health and reducing the need for some medications. Below, FENIX provides thoughts on Virta’s funding and valuation in the context of the recent Livongo/Teladoc merger as well as brief thoughts on the Virta value proposition.
Pharmaceutical Strategies Group (PSG) announced the launch of a diabetes cost management tool, called “Total Cost of Diabetes Care,” designed for health plans and employers to manage the total cost of diabetes care among their users (view PSG website). Below, FENIX provides highlights from the press release as well as potential readthrough to companies like Livongo, Dario, and Onduo.
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)).
Amgen (press release) and Cytokinetics (press release) separately announced Amgen provided notice to Cytokinetics of its intention to return development and commercial rights for omecamtiv mecarbil (cardiac myosin activator) and AMG 594 (cardiac troponin activator). Cytokinetics also hosted a call with investors to provide commentary regarding Amgen’s decision and next steps for omecamtiv. Below, FENIX provides thoughts on Amgen’s decision, in the context of other recent partnership dissolution examples, as well as implications from the upcoming Entresto FDA adcom.