Two new Ph1 trials for Lilly’s tirzepatide have been observed on CT.gov, including a T2DM counter-regulatory response trial to hypoglycemia and another trial evaluating multiple injection sites in subjects with various BMIs. Below, FENIX provides thoughts on the respective trials.
Novo Nordisk hosted its Q2 ’19 earnings call and provided updates to its diabetes business including the recent initiation of the first-in-human study of its novel basal insulin FSI965 as well as Ph2 completion of its anti-IL 21+liraglutide Ph2 trial in new-onset T1DM. Additionally, Novo disclosed that Mylan notified Novo of an ANDA Paragraph IV filing for generic Victoza. Below, FENIX provides highlights and insights from the call including potential readthrough from the recently scheduled Amarin REDUCE-IT adcom (and likely PDUFA delay) to the ongoing oral semaglutide FDA review.
MannKind and Senseonics hosted their Q2 ’19 earnings calls and provided updates to their respective diabetes businesses. Below, FENIX provides highlights and insights from the calls.
Yesterday, Xeris published its Q2 ’19 earnings press release highlighting the September 10, 2019 PDUFA for its hypoglycemia rescue product ‘Gvoke.’ Gvoke launch is anticipated in Q4 ’19. Furthermore, the company disclosed utilizing the additional data from the fourth Ph3 trial to file an MAA to EMA by YE 2019. Below, FENIX provides additional thoughts on Gvoke in the context of its additional Ph3 data, and other novel glucagon rescue products.
BD hosted their CY Q2 ’19 (FY Q3 ’19) earnings call (press release) and provided a brief update on their diabetes business unit including the 510(k) withdrawal of their Swatch pump for T2DM. Below, FENIX provides further details on the Swatch pump 510(k) withdrawal and insight into its impact on the T2DM patch pump segment.
Insulet hosted its Q2 ’19 earnings call and provided updates to its commercial and pipeline activities including the Omnipod Horizon hybrid closed-loop development. Below are highlights and insights from the call.
Today, three key news items were observed including the Forxiga DECLARE EU approval, Breakthrough Therapy Designation to Provention Bio’s Teplizumab (PRV-031) and a MannKind/ One Drop collaboration. Below, FENIX provides context and analysis for these announcements.
Lilly has initiated SURPASS-5 (add-on to glargine) which is the 5th and final tirzepatide pivotal Ph3 trial for T2DM. Below, FENIX provides an overview of SURPASS-5 as well as insight into why the study is likely using background glargine U100 and not all basal insulins as well as a high-level comparison between SURPASS-5 and the Trulicity AWARD-9 study.
A new Jardiance TV DTC commercial, called “Audrey is on it,” has been observed. Of note, the commercial is set to the tune of the 1981 hit “Apache (Jump on it)” by the Sugarhill Gang, potentially in response to the success of other T2DM commercials that have also used jingles (Ozempic, Farxiga, and Tresiba). Below, FENIX provides analysis of the Jardiance TV commercial including insight on how the commercial’s football/marching band theme is apropos leading into the NFL and college football seasons.
Tandem Diabetes Care hosted its Q2 ’19 earnings call and provided updates to its t:slim pump business. Additionally, Tandem announced that all software updates through YE 2020 will be provided free to users with in-warranty pumps. Below, FENIX provides highlights and insights from the call.