BI/Lilly announced that the CAROLINA CVOT met the primary endpoint of non-inferiority on 3P-MACE vs. glimepiride. Full results from the study are scheduled to be presented on June 10 at the ADA conference. Below, FENIX provides thoughts on CAROLINA and how OAD market dynamics are unlikely to be affected, continuing the slow decline of SU volume share.
AstraZeneca hosted its Q4 ’18 earnings call and provided a brief update on its diabetes business including Farxiga LCM initiatives (T2DM CVOT, T1DM, HF, and CKD). Of note, as part of AZ’s business reorganization, MedImmune has been fully integrated including the dissolution of the MedImmune name. Below, FENIX provides highlights and insights from the earnings call including thoughts the generic dapa patent dispute, PDUFA projections for Farxiga T1DM and DERIVE CKD, and AZ’s dual agonist from MedImmune.
Xeris announced a proposed public offering of 5M additional shares; and, in the S-1 document, disclosed the commercial name of its stable glucagon as “Gvoke” believed to be pronounced (gee’-voke), which appears to be a play on the word “evoke.” Below, FENIX provides key highlights from the S-1 filing, thoughts on the impending Xeris glucagon launch in H2 ’19 (June 10, 2019 PDUFA date), and insight on potential read-through to Xeris from FDA’s upcoming decisions on Sanofi/Lexicon’s sotagliflozin in T1DM (March 22, 2019 PDUFA date) and Lilly’s nasal glucagon (PDUFA believed to be in April 2019).
Recently, FENIX has observed new Lilly and Novo pump trials on CT.gov. Lilly has posted a Ph3 trial for its ultra-rapid-acting insulin lispro (LY900014; URLi) for pumps in adults with T1DM called ‘PRONTO-Pump-2.’ Additionally, Novo has initiated a new Ph2 trial for Fiasp in an iLet Bionic Pancreas. Below, FENIX provides thoughts on the respective studies.
Earlier this week, FDA tentatively approved Teva’s generic version of Farxiga. Below, FENIX provides evidence suggesting Teva filed its generic dapa via Paragraph III as well as thoughts on potential generic dapa launch timings, particularly Zydus.
Today, Sanofi hosted its Q4 ’19 earnings call, provided updates to its diabetes business, and disclosed that it discontinued SAR425899 (GLP-1/GCGR) and SAR438335 (GLP-1/GIP) for the treatment of obesity in T2DM and T2DM, respectively. Of note, Sanofi’s CEO will be testifying at the February 26, 2019 Senate Committee hearing on drug pricing. Below, FENIX provides highlights from the call as well as thoughts on Sanofi’s position in diabetes, obesity, and NASH.
Novo Nordisk hosted its post-Q4 ’18 earnings event in London. The session included a brief presentation from management followed by Q&A which primarily focused on Novo’s priority review voucher (PRV) for oral semaglutide. Below, FENIX provides highlights and analysis from the call, as well as the scenario that Lilly could use its PRV for REWIND to keep pace with Novo.
BD held their Q4 ’18 earnings call and provided a brief update on their diabetes business unit. Senior management disclosed they have filed their T2DM patch pump in the US and European and anticipate a launch in late 2019. When asked by an analyst about their market approach for the T2DM patch pump, senior management commented that BD is in the process of defining their channel strategy. Furthermore, management does not anticipate any new clinical data to presented at ADA 2019.
JDRF has issued a press release criticizing UnitedHealthcare’s decision to extend Medtronic’s exclusive status for supplying insulin pumps to its covered lives. Recall, Medtronic first signed the deal with UHC in May 2016, which applied to patients 18 years of age and older. However, with FDA’s approval of the 670G pump in patients down to 7 years of age, UHC has extended the agreement to this population. Patients on existing pump therapy or patch pumps (e.g. Insulet Omnipod) are not impacted. Below, FENIX provides thoughts on UHC’s decision, the potential impact to Tandem’s pump business, and the potential irony of JDRF’s criticism.
Senseonics announced it has come to an agreement with Roche to extend the existing distribution agreement for the Eversense implantable CGM. Additionally, Senseonics held an investor webcast to discuss the updated agreement. Below, FENIX provides a summary of the webcast as well as thoughts on why it may have made more sense for Roche to extend the partnership than to outright buy Senseonics.