Novo Nordisk hosted its post-Q1 ’19 earnings event in London. The session included a brief presentation from management followed by Q&A. Below, FENIX provides highlights and insights from the call.
Novo Nordisk hosted its Q1 ’19 earnings call (press release) and provided updates to its diabetes business including the recent oral semaglutide and Ozempic regulatory filings. Of note, Novo reported topline results from the Tresiba vs. Toujeo H2H trial. Below, FENIX provides highlights and insights from the call including thoughts on how the Tresiba vs. Toujeo H2H trial may impact the basal insulin market.
Merck and Pfizer hosted their respective Q1 ’19 earnings calls. Both companies only briefly discussed their diabetes-related businesses. Below, FENIX provides highlights from the calls.
Lilly hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for “technical reasons,” and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 ’19 regulatory events in diabetes.
Yesterday, Novo Nordisk presented results from the Victoza T2DM pediatric trial (ELLIPSE) at the Pediatric Endocrine Society/Pediatric Academic Societies annual meeting. Importantly, the results were published in the NEJM, which may be a testament to the growing attention on childhood T2DM/obesity. Additionally, Novo disclosed that it has submitted the data to US and EU regulators, although it did not specify the timing. Below, FENIX provides an overview of the ELLIPSE results – including the non-significant weight loss findings, and thoughts on the study in the context of Victoza’s impending LOE and recent settlement with Teva.
Sanofi hosted its Q1 ’19 earnings call but only briefly discussed its diabetes business including the recent sotagliflozin T1DM CRL. Below, FENIX provides highlights and insights from the call.
AstraZeneca hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, senior management disclosed that its Farxiga CVOT (DECLARE) filings have been accepted by US and EU regulatory authorities with approvals projected in 2020. Additionally, AZ said its Farxiga HF study (Dapa-HF) is projected to read out ahead of schedule (now in H2 ’19; previously 2020). Below, FENIX provides highlights and insights from the Q1 ’19 earnings call.
A CT.gov record for Novo’s oral semaglutide CVOT, SOUL, has been observed. Novo recently announced the simultaneous filings for oral semaglutide T2DM glycemic control, oral semaglutide CV risk reduction, and Ozempic CV risk reduction. Below, FENIX provides a comparative GLP-1RA CVOT analysis as well as key considerations for the SOUL trial.
According to Drugs@FDA, the Ozempic US label has been updated to reflect a new 3mL pen offering for a maintenance dose of 1mg. The new pen has a different NDC (0169-4130-13) and dials 4 doses of 1mg each. The new pen represents a total strength of 4 mg/3 mL and harmonizes the maximum pen strength offered in Europe. Below, FENIX provides thoughts on this new pen offering including potential reasons around manufacturing efficiencies.
Sanofi is reportedly set to lay off an undisclosed number of diabetes US sales reps starting in June 2019. Below, FENIX provides thoughts on the new layoffs in the context of increasing US pricing pressures on Sanofi’s insulin franchise as well as the recent sotagliflozin CRL.