Merck hosted its Q2 ’19 earnings call but did not provide any updates to its diabetes business beyond the Januvia and Steglatro financial performances. Unsurprisingly, the vast majority of the discussion was focused on Merck’s oncology and HIV portfolios. Below, FENIX provides diabetes-related highlights from the call.
Lilly hosted its Q2 ’19 earnings call and provided updates across its diabetes business. Of note, Lilly’s pipeline now lists empa T1DM as being filed (FDA refused to accept the initial sNDA). Following the 36-week results from Lilly’s AWARD-11 study, Lilly said it plans to file high-dose Trulicity with regulatory authorities “by late 2019.” Furthermore, Lilly’s oral GLP-1RA, called “GLP-1 NPA” (GLP-1 non-peptide agonist), has advanced to Ph1. Below, FENIX provides diabetes-related highlights and insights from the call, including the assumption that the REWIND CHMP agenda listing for July was only for adoption of supplementary information.
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.
A CHMP opinion on Lilly’s REWIND CVOT was anticipated on Friday, July 26; however, there has been no press release from Lilly nor is REWIND listed on the July 2019 CHMP meeting highlights. Below, FENIX provides brief thoughts on the REWIND EU regulatory situation.
In a press release announcing topline results from three Ph3 sotagliflozin T2DM trials, Sanofi disclosed that it is “terminating the collaboration to develop, manufacture, and commercialize Zynquista in all ongoing global type 1 and type 2 diabetes programs.” Following Sanofi’s press release, Lexicon issued its own statement declaring Sanofi’s “notice invalid and Sanofi to be in breach of contract.” Below, FENIX provides initial thoughts and insights about the partnership termination including readthrough to AZ and BI/Lilly.
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.
Recently, Lilly’s novel nasal glucagon hypo rescue product, Baqsimi [BAK-see-mee], was approved by FDA. Below, FENIX provides an in-depth analysis of the Baqsimi label, pricing strategy, and potential market implications for other novel glucagon rescue products from Xeris, Zealand, and Mylan.
Roche hosted its Q2 ‘19 earnings call and provided brief updates to their diabetes business. Of note, Roche’s earnings press release stated that the Accu-Chek Guide Me, a low-cost version of the Accu-Chek Guide, has been launched in the US. Below, FENIX provides highlights from the call.
AZ hosted its Q2 ’19 earnings call and provided updates to its diabetes commercial, clinical, and regulatory activities. Importantly, AZ updated the DECLARE US/EU regulatory decision timelines which are now both anticipated in H2 ’19 (previously said to occur in 2020). AZ also disclosed it has a new Ph1 GLP-1RA compound (MEDI7219). Discussion regarding the Farxiga T1DM CRL was minimal. Below, FENIX provides diabetes-related highlights and insights from the call.
Lilly’s nasal glucagon has been approved by FDA under the brand name “BAQSIMI”. Recall, during Lilly’s Q1 ’19 earnings call, Lilly announced that FDA delayed the approval by 3 months. FENIX will be conducting an in-depth label analysis in the coming days.