Today, nine major news items were observed including Novo’s PIONEER 2 (vs. Jardiance) and PIONEER 4 (vs. Victoza) data readouts, new Medtronic closed-loop, and CGM pivotal trials, and more. Below, FENIX provides context and analysis for the announcements.
Today, four major new items were observed including two new Tidepool partnerships with Medtronic and Dexcom as well as updated Companion Medical InPen features and Monarch Medical’s IOB algorithm 510(k) approval. Of note, the Medtronic/Tidepool partnership is believed to be the first external partnership as part of Medtronic’s notoriously closed diabetes device ecosystem. Below, FENIX provides context and analysis for the announcements.
Today, seven major new items were observed across Sanofi, Dexcom/Companion Medical, Xeris, Senseonics, Zealand/Beta Bionics, vTv, and Adocia. Below, FENIX provides context and analysis for the announcements.
Ahead of the ADA 2019 conference start, a series of diabetes-device related press releases have been observed including Companion Medical, Glooko, DreaMed, Roche, CeQur, and Virta Health. Below, FENIX provides context and analysis for the announcements.
Lannett, a Philadelphia-based generic pharmaceutical company, announced the initiation of a first in-human clinical trial for its biosimilar glargine which is being co-developed through a strategic alliance with YiChang HEC ChangJiang Pharmaceutical Co. (part of the HEC Group of companies). Lannett plans to use the study to support future development with the intent of pursuing approval in the US. Below, FENIX provides insight into the Lannett bs-glargine and thoughts on how the recent FDA guidance on biosimilar interchangeability may have been a catalyst for its development.
Boehringer Ingelheim and Lilly announced FDA accepted the NDA filing for their empagliflozin+linagliptin+metformin XR triple FDC for the treatment of T2DM. Below, FENIX provides brief thoughts on the emerging triple combination market in the context of the recent FDA approval for AstraZeneca’s QternmetXR (dapagliflozin+saxagliptin+metformin XR).
With the upcoming Trulicity CVOT (REWIND) presentation at ADA 2019 (Sunday, June 9 at 4:30-6:30 pm PT), and in the context of the other GLP-1RA CVOTs (particularly LEADER, SUSTAIN 6, PIONEER 6, and HARMONY), the FENIX team is decidedly split on how positive the REWIND results will be. Below, FENIX presents Matt’s bold prediction for a hit on all-cause mortality vs. the team’s more moderate consensus of a LEADER-like ~13% RRR with a potential miss in the primary prevention cohort.
In the fourth and final installment of our post-AACE 2019 promotional material coverage, FENIX has conducted an analysis of diabetes devices promotional materials covering CGMs (Dexcom, Abbott, and Senseonics), pumps (Tandem and Insulet), and Connected Pens (Companion Medical). Of note, there were no promotional materials observed for any Medtronic devices. Below, FENIX provides an overview of the AACE 2019 diabetes devices promotional materials including Dexcom’s counter-messaging of the Abbott Libre CGM as well as all new Insulet Omnipod DASH promotion.
Medtronic hosted its CY Q1 ’19 (FY Q4 ’19) earnings call and provided updates to its diabetes business unit. Of note, the first trial for Medtronic’s advanced hybrid closed loop has recently been observed on CT.gov. Furthermore, Medtronic said it plans to host an investor event during ADA on June 9, 2019 where it will provide a more detailed update on its diabetes product roadmap. Below, FENIX provides highlights and insights from the call.
Novo Nordisk recently initiated three new studies (two Ph2 and one Ph1) for its QW basal insulin (LAI287). The Ph2 studies are separately evaluating strategies to initiate and titrate LAI287 while the Ph1 trial is helping to further characterize the PK/PD profile with a crossover with glargine U100. Below, FENIX provides insights about the new LAI287 trials including thoughts how these trials are helping to answer logistical questions surrounding a potentially first-in-class QW insulin.