Diabetes device company Lifescan, famous for its OneTouch portfolio of BGM products, partnered in May 2019 with Sanvita Medical to develop and commercialize a CGM system (previous FENIX insight). Below, FENIX describes how Lifescan/Sanvita redacted the details of a CT.gov record for its latest feasibility trial evaluating the Sanvita CGM system.
Dexcom hosted its 2020 Investor Day event and provided updates across its business, including its R&D roadmap, T2DM commercial focus, and international expansion. Interestingly, the event was patient and HCP-focused and comprised of three discussions with HCPs who use CGM in various capacities (including non-diabetes-related). Below, FENIX provides highlights from the event as well as insight into Dexcom’s ongoing transition to focus beyond T1DM and intensively managed T2DM patients.
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.
Two diabetes-related news items have been observed: late last week, FDA approved Saxenda for the treatment of obesity in adolescents (view press release); and FDA issued a press release stating the Januvia franchise has not been proven to improve glycemic control in pediatric patients (ages 10-17) with T2DM (view updated Januvia label). Below, FENIX provides thoughts on how the label updates are anticipated to impact the respective brands.
The CHMP agenda for this month (December 7-10) has been released, and it includes two notable items, potential CHMP opinions for Biocon/Mylan’s insulin aspart and Xeris’s glucagon, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the December 2020 CHMP agenda.
Novo Nordisk announced the Danish Maritime and Commercial High Court ruled Novo’s September 19, 2019 press release regarding the full results from the CONCLUDE trial (H2H Tresiba vs. Toujeo in T2DM; view original press release here) violated the Danish Marketing Practices Act and the Danish Medicines Act. However, Novo did not disclose which specific portion of the September 2019 press release was in violation. In case you missed it, here is a link to FENIX’s insight on the CONCLUDE result following the presentation at EASD 2019.
Novo Nordisk announced it has filed the NDA for the semaglutide 2.4mg obesity indication. Recall, Novo disclosed in October 2020 that it would be using a PRV voucher, which reduces the review to 6 months. Below, FENIX provides thoughts on the anticipated approval timeline for sema 2.4mg and readthrough to Novo’s AM833 (amylin analog) development.
A series of events and observations have been made that suggest the Libre 2 US commercialization remains in a soft launch; however, a broad launch of the Libre 2 system may be in the near term. Below, FENIX provides analysis on the Libre 2 soft launch, potential insight into Abbott’s rationale to simultaneously market Libre 14-day and Libre 2, and thoughts on whether Abbott would minimize Libre 2 promotional efforts if Libre 3 US approval is around the corner.
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.