Sanofi hosted its Q2 ’19 earnings call and provided updates to its diabetes business unit including the recent Ph1 initiation for its GLP/GIP/GCG triple agonist (SAR441255). Unsurprisingly, Sanofi did not discuss its recent decision to terminate the Lexicon partnership for sotagliflozin. Below, FENIX provides diabetes-related highlights and insights from the call.
Biocon hosted its CY Q2 ’19 (FY Q1 ’20) earnings call and briefly discussed its biosimilar insulin programs including bs-glargine and bs-aspart. Of note, Biocon recently initiated three Ph1 PK/PD studies for its rHI portfolio. Below, FENIX provides highlights and insights from the call.
Senators Dick Durbin, Kevin Cramer, and Tina Smith introduced a new bipartisan bill called the Affordable Insulin Approvals Now Act, with the intention to accelerate approvals of generic insulin products. According to the sponsors, the new bill is intended to address the unintended consequence of the 2018 Biologics Price Competition and Innovation Act which created a deadline (March 23, 2020) whereby all pending applications for generic insulin would be automatically rejected. Under the new bill, FDA would be required to continue the reviews of any pending applications. Below, FENIX provides thoughts on the Affordable Insulin Approvals Now Act in the context of the insulins that may be impacted by the March 23, 2020 cutoff date (e.g. Biocon/Mylan bs-glargine, Biocon/Mylan bs-aspart, Sanofi bs-aspart, and Sandoz bs-glargine which was in-licensed from Gan & Lee).
Biocon has received an additional twelve 483 observations from an FDA inspection of Biocon’s Malaysian facility. The 483 observations were a result of an FDA pre-approval inspection for the bs-glargine product; however, the company did not provide any specific details. No result was found during a search of FDA’s inspection citations. According to Biocon, the inspection is not anticipated to impact plans for US commercialization. Below, FENIX provides context and insight regarding these 483 observations.
Today, Biocorp and Sanofi announced they have entered into exclusive negotiations for integrating Biocorp’s connected cap device into the Sanofi connected care platform. Below, FENIX provides read-through on what the Biocorp-Sanofi deal may signal.
Consistent with Adocia’s ADA 2019 press release, a clinicaltrials.gov record has recently been observed for the company’s pramlintide + insulin (ADO09) Ph1b study. Below, FENIX provides an overview of the ADO09 Ph1b trial including thoughts on the market potential for ADO09 as a T1DM adjunctive therapy.
According to Reuters, Sanofi is set to layoff 466 R&D-related jobs as part of an initiative to prioritize oncology, immunology, rare diseases, and vaccines while at the same time limiting internal CV R&D to its current pipeline. Furthermore, Sanofi is said to maintain the support of its diabetes and CV programs through its partners. Below, FENIX provides thoughts on the Sanofi R&D re-focusing in the context of the company’s CV/Met pipeline and recent senior management changes.
14 major news items were observed over the past 2 days including Provention Bio’s teplizumab, dasiglucagon pivotal data, DECLARE and EMPA-REG subanalyses, Afrezza pediatric and fixed titration data, Tandem and Insulet hybrid-closed loop data, and more. Below, FENIX provides context and analysis for the announcements.
Novo Nordisk hosted its ADA 2019 investor event immediately following the data readout from Lilly’s REWIND CVOT. Unsurprisingly, Novo compared REWIND to LEADER and SUSTAIN 6. Of note, Novo disclosed plans to initiate its high-dose semaglutide study, SUSTAIN FORTE, in Q2 ‘19. Other topics covered during the call include semaglutide LCM, commentary on Lilly’s tirzepatide, connected pen data, QW basal insulin (LAI287), and more. Below, FENIX provides insights and highlights from the call.
Today, four major new items were observed including two new Tidepool partnerships with Medtronic and Dexcom as well as updated Companion Medical InPen features and Monarch Medical’s IOB algorithm 510(k) approval. Of note, the Medtronic/Tidepool partnership is believed to be the first external partnership as part of Medtronic’s notoriously closed diabetes device ecosystem. Below, FENIX provides context and analysis for the announcements.