Ascensia has announced improved Tier 2 access to Contour NEXT meters and test strips for UnitedHealthcare members. Previously, UHC’s PBM, OptumRx, only covered LifeScan’s OneTouch BGMs and test strips, excluding Contour products.
Lilly and Sigilon Therapeutics announced a collaboration to develop encapsulated beta cell therapies for the potential treatment of T1DM. While other beta cell therapies have remained in early stages of development, Lilly’s financial support and considerable resources greatly increase the likelihood of Sigilon’s therapy advancing.
AZ has announced FDA approval of Bydureon as an add-on to basal insulin for T2DM based on the results of the DURATION-7 study. The corresponding label update may help strengthen a Bydureon message of broad use including first-injectable therapy and treatment intensification.
In conjunction with the Dexcom G6 approval FDA created a new device category under class II defined as “integrated continuous glucose monitoring,” or iCGM. Below, FENIX has provided an analysis and summary of this class’ FDA controls in the context of future CGM development by manufacturers such as Dexcom, Abbott, Medtronic, and Senseonics.
FDA and Dexcom announced approval of the Dexcom G6 CGM after a notably short 6-month review time, suggesting increased FDA comfort with CGM technology. The new device is the first real-time CGM approved for standalone and interoperable use. Launch is anticipated in Q2 ‘18, and Dexcom is projected to have a significant presence at ADA.
Briefing documents for the Senseonics implantable Eversense CGM were posted today by FDA in advance of the March 29, 2018 adcom. Also of note, FDA today announced approval of the Dexcom G6 and a new lower risk classification of interoperable CGM (“iCGM”). Below, FENIX has analyzed the key issues anticipated to be discussed during the adcom.
AZ has begun actively promoting Bydureon BCise, the new autoinjector device which became available in US pharmacies in January 2018. Below, FENIX has conducted a launch analysis in the context of the broader GLP-1RA market including assessment of prescription data trends.
Novo Nordisk began actively promoting Ozempic (sc QW semaglutide) in the field in early February 2018, two months after the December 2017 approval. Below, FENIX has conducted a launch analysis, including thoughts on promotional materials, sampling strategy, and early insights from NRx trends.
J&J announced it has received an offer from Platinum Equity to purchase LifeScan for $2.1B. According to the press release, the acceptance period for the offer ends June 15, 2018 with closing of the deal to occur by YE ’18. Below, FENIX provides insight on the potential opportunity that Platinum Equity may see for the LifeScan business.
Two new clinical trials for Lilly’s ultra-rapid-acting insulin lispro (LY900014; also called ultra-rapid lispro or “URLi” pronounced “early” [ur-lee] by Lilly at ATTD 2018), have been observed on CT.gov including a Ph1 H2H PK trial vs. Novo’s Fiasp and a Ph3 study in pumps called PRONTO-Pump.