Category Archives: Topics

Sanofi Discontinues Tri-Agonist; Sanofi Q3 ’19 Earnings Update

Sanofi hosted its Q3 ’19 earnings call and provided updates to its diabetes business unit. Importantly, Sanofi disclosed it has discontinued the development of its Ph1 GLP/GIP/GCG triple agonist (SAR441255). Of note, Q3 ’19 was the first earnings call with its new CEO, Paul Hudson. Sanofi will also be hosting a Capital Markets Day on December 10 to discuss the company strategy under new senior leadership. Below, FENIX provides highlights and insights from the call including thoughts on the future of Sanofi in the diabetes market.

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New Semaglutide Formulations in Ph2 Pen Trial

A CT.gov record for a new Ph2 trial has been observed comparing FlexTouch (PDS290) to the DV3396 pen as well as two different formulations of semaglutide (“Semaglutide B” and “Semaglutide D”). Recall, in July 2019, Novo initiated a nearly identical Ph2 study evaluating two formulations of semaglutide in the same injectors. Below, FENIX provides updated insights regarding the trials, DV3396 injection device, and the new semaglutide formulations.

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New Biocon Ph1 Oral Insulin Trial

A CT.gov record for a new Ph1 trial evaluating Biocon’s oral insulin Tregopil has been observed. Of note, the trial is being conducted by Profil in Mainz, Germany. Below, FENIX provides thoughts and insights into insulin Tregopil’s development including the challenges and commercial opportunity particularly around cold chain storage in underdeveloped geographies.

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Thoughts on Verily/Onduo Novel Diabetes Life Insurance Program

Verily, Onduo, and John Hancock recently launched a novel program, called “John Hancock Aspire,” which offers life insurance to patients with diabetes. As part of the program, eligible T2DM participants will have access to Onduo’s diabetes management and coaching solution. According to the press release, Aspire life insurance will be available starting November 18, 2019. Below, FENIX provides thoughts on this new program including insight into the motivating factors for each company and the potential business model.

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New Lilly Ph1 Trial; Likely GGG Tri-agonist

Lilly has initiated a new Ph1 trial evaluating an unknown compound (LY3437943) vs. Trulicity in T2DM patients. Below, FENIX has conducted an analysis to help identify the compound and potential MOA.

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Merck and Pfizer Q3 ’19 Earnings Updates

Merck (press release) and Pfizer (press release) hosted their respective Q3 ’19 earnings calls. Both companies briefly discussed their diabetes-related businesses. Below, FENIX provides highlights from the calls.

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Omnipod Approved to use Novo’s Fiasp; Senseonics Now Covered on Humana

Insulet announced it has received 510(k) clearance to use Novo’s Fiasp in Insulet’s Omnipod patch pump. Recall, earlier this week, Novo announced it received FDA approval for Fiasp pump compatibility in adult patients requiring insulin therapy. Additionally, Senseonics announced that Humana will now be providing coverage for the Eversense implantable CGM system and insertion procedure (effective October 22, 2019). Below, FENIX provides brief thoughts and potential market implications for each news item.

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Biocon CY Q3 ’19 (FY Q2 ’20) Earnings Update

Biocon hosted its CY Q3 ’19 (FY Q2 ’20) earnings call and briefly discussed its biosimilar insulin programs including bs-glargine, bs-aspart and bs-rHI. Recall, Biocon/Mylan received a CRL from FDA for bs-glargine submission in September 2019 (previous FENIX insight). Of note, Biocon indicated it is confident in resolving the CRL and anticipates FDA approval prior to the March 2020 insulin reclassification. Below, FENIX provides highlights and insights from the call.

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AstraZeneca Q3 ’19 Earnings Update

AZ hosted its Q3 ’19 earnings call (press release) and provided updates to their diabetes commercial, clinical, and regulatory activities. Importantly, AZ highlighted the DECLARE US and EU approvals as well as continued HF and CKD LCM for Farxiga. Below, FENIX provides diabetes-related highlights and insights from the call.

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