Lexicon hosted its R&D Day and provided an overview of clinical and regulatory activities for its diabetes portfolio including sotagliflozin and LX2761 (selective SGLT1i). Below, FENIX provides highlights of the R&D day as well as thoughts on the impact of sotagliflozin on the T1DM and T2DM markets.
Livongo announced a new $105M round of funding and a new strategic partnership. The new funding round brings the total capital raised by Livongo to $243.2M. The new strategic collaboration with Cambia Health Solutions will focus on improving personalized health care for patients with chronic conditions and brings on a new investor named Echo Health Ventures.
Mylan hosted its Investor Day and provided updates on biosimilar Lantus and Novolog, as well as disclosing for the first time its intentions to develop biosimilar versions of Toujeo, Victoza, and Saxenda. Below, FENIX provides analysis and market implications for each of the biosimilar programs.
Zealand has announced a collaboration with Roche for the Ph3 development of Zealand’s dasiglucagon for the treatment of congenital hyperinsulinism. Below, FENIX further analyzes this scenario.
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.