Novartis hosted its Q4 and full year 2017 earnings updates. Novartis briefly discussed its SGLT1/2i (LIK066), which is being developed for obesity. Of note, Novartis said it anticipates completing their Ph2b trial in H2 ’18 with Ph3 to potentially initiate as early as YE ’18 or early 2019. Below are highlights from the calls.
J&J hosted their Q4 ’17 earnings call and briefly discussed the diabetes business unit, including declining Invokana sales and the future of their diabetes device business. Notably, in response to analyst questions regarding potential diabetes divestitures, management was noncommittal.
Johnson & Johnson’s diabetes business unit is reportedly being assessed by a number of Chinese investors in a deal which could gross up to $4 billion. Potential bidders are said to include Chinese diabetes care companies such as Sinocare Inc and financial institution China Jianyin Investment Ltd (JIC).
On the first day of the J.P. Morgan Healthcare Conference, key diabetes manufacturers including J&J, Merck, Medtronic, Abbott, and Pfizer presented regarding their commercial and R&D activities. Of note, Pfizer did not discuss their diabetes portfolio. Below, find a topline summary of key takeaways by company followed by more in-depth coverage.
FENIX has conducted a pricing analysis of the SGLT2i and SGLT2i+DPP-IVi FDC classes.
Two new Sanofi-sponsored clinical trial records for sotagliflozin, SOTA-CKD3 and SOTA-CKD4 have been observed. The aim of the studies is to demonstrate that sotagliflozin provides superior A1C reductions in patients with T2DM and renal impairment (stage 3 and stage 4) compared to placebo.
Results of the CV outcomes trials meta-analysis for canagliflozin, CANVAS and CANVAS-R, were published in the NEJM in conjunction with the data presentation at ADA ’17. A one-hour session reviewed background and trial design including the study population and integrated analysis methods, CV outcomes, renal outcomes, safety, and context.
J&J hosted their pharmaceutical business review and provided commentary on the Invokana boxed warning, CANVAS/R and CREDENCE, and their pipeline dual GLP-1/glucagon agonist from Hanmi.
FDA has issued a Drug Safety Communication regarding an increased risk of lower limb amputations associated with canagliflozin therapies (Invokana, Invokamet, Invokamet XR) based on results from the CANVAS CV outcomes study. As such, FDA is requiring a Boxed Warning to be added to the labels of the respective drugs.
Lexicon has announced additional positive data from the Ph3 inTandem1 study. Of note, a slight increase in DKA was seen in the sotagliflozin groups during the extension period with 6 cases (2.5%) on 200mg and 3 cases (1.3%) for 400mg compared to 1 patient (0.4%) on placebo.