In advance of ADA 2018 beginning June 21, FENIX has conducted a comprehensive analysis of new and recent promotional materials obtained at AACE 2018. Notably, this was the first major conference opportunity for Novo to promote both Ozempic and the Tresiba DEVOTE label update.
Novo Nordisk has announced topline results from the Ph3 PIONEER 2 study comparing oral semaglutide to BI/Lilly’s Jardiance. Interestingly, this is the second oral semaglutide trial to have topline results (PIONEER 1 FENIX insight); and in each case, Novo has only disclosed on-treatment results. Below, FENIX provides insight into PIONEER 2 results and the impact on oral semaglutide commercialization.
AZ hosted their Q1 ’18 earnings call and briefly discussed their diabetes portfolio, with a particular focus on Farxiga, including H2 ‘18 readout of the DECLARE CVOT and planned H2 ’18 US filing in T1DM.
During Novo’s Q1 ’18 London earnings webcast, senior management discussed potential scenarios surrounding the recently-purchased priority review voucher (PRV), including its use for either oral semaglutide or a semaglutide obesity indication. Below, FENIX provides its thoughts on how the PRV serves as insurance to a successful launch for oral semaglutide, as well as some anticipated triggers for its usage.
Novo hosted its Q1 ’18 earnings call (press release) and provided updates on its marketed and pipeline diabetes products. Of note, Novo discussed the relaunch of Tresiba based on the recent DEVOTE label update. Furthermore, Novo disclosed plans to initiate Ph2 for its QW basal insulin (LAI287) by YE ’18. Below are highlights from the call.
Novo Nordisk has announced its participation in the Hypo-RESOLVE research project. FENIX has made a curious observation based on the press release, which references Stephen Gough as Novo’s “Global Chief Medical Officer in Denmark.” This position was believed to be held by Alan Moses.
Lilly hosted its Q1 ’18 earnings call (press release) and provided updates on its diabetes business unit. Of note, Lilly affirmed REWIND (Trulicity CVOT) topline readout is anticipated in early Q4 ’18 with full results at ADA 2019. Below are highlights from the call.
Sanofi announced that Elias Zerhouni, the company’s Head of Global R&D, is retiring and will be succeeded by John Reed, the former Global Head of Roche Pharma Research & Early Development.
A new Ph3 trial (AWARD-11) evaluating 3.0 and 4.5mg Trulicity has been observed on CT.gov. The trial is projected to complete in Q4 ’19. If no additional trials are required, launch could occur as early as Q1 ‘21 (assuming a full 10-month review).
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.