Category Archives: Topics

Thoughts on Lexicon Closing Its Sota CVOTs

Yesterday, Lexicon announced the early close out of its sotagliflozin CVOTs, SCORED and SOLOIST, mainly due to operational challenges with COVID-19 and the low likelihood of finding a commercialization partner (press release). Below, FENIX provides highlights and insights surrounding this update, including the potential generalization to BI/Lilly’s EMPEROR HF studies, and larger thoughts on Lexicon’s pivot away from sotagliflozin.

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Xeris Home Delivery via Amazon; Oramed End-of-Ph2 FDA Feedback

Two diabetes news items were observed today. First, Xeris made Gvoke PFS available for home delivery via Amazon Pharmacy and grounded its field force (press release). Of note, Gvoke PFS is now available for home delivery to commercially insured patients through PillPack by Amazon Pharmacy and Xeris has grounded its field force. Additionally, Oramed announced positive feedback from its oral insulin ORMD-0801 End-of-Phase2 (EoP2) CMC meeting with the FDA (press release). Below, FENIX provides highlights and thoughts surrounding these updates, including how the home delivery option could present an opportunity for Xeris and Zealand amid the COVID-19 pandemic.

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Medtronic To Move Away From Its Non-Intensive Diabetes Strategy

According to a March 18 Medtronic research note from Morgan Stanley entitled “Diabetes Group Restructured”, Medtronic is restructuring its diabetes group to focus its core efforts on insulin-dependent T1DM+T2DM patients while moving away from their non-intensive strategy. Below, FENIX provides thoughts on the new direction for Medtronic’s business.

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Nemaura to Use Wellness Category for US CGM Launch

Nemaura announced plans to launch its non-invasive sugarBEAT CGM in the US under the wellness category following feedback from the FDA (press release). Below, FENIX provides insight on this new foray for CGM in the US, especially in the context of how other marketed CGMs use a non-adjunctive claim to dose insulin for diabetes management.

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DarioHealth Q4 ’19 Earnings Update

DarioHealth hosted its Q4 ’19 earnings call (press release) and provided brief updates to its commercial developments and strategic collaborations. Of note, management indicated that they currently have ~46k active users, including the users from the membership program and those with device usage. Below, FENIX provides additional highlights and insights from the call.

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Mylan/Aurobindo Invalidates Two Tradjenta Patents; PRV-031 (Teplizumab) Ph3 PROTECT Trial Paused

According to new court documents (view here) released yesterday, two Boehringer patents on Tradjenta were ruled invalid by the U.S. Court of Appeals for the Federal Circuit upon reviewing the appeal by Mylan and Aurobindo. Additionally, Provention Bio announced a temporary pause in the patient randomization of the Ph3 PROTECT trial for PRV-031 (teplizumab) in patients with newly diagnosed T1DM amid the COVID-19 crisis (press release). Of note, the company is on track to complete its rolling BLA submission for teplizumab treatment of at-risk patients for T1DM in Q4 ’20. Below are the key highlights and insights from these new items.

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New Pfizer Oral GLP-1RA Compound in Ph1

A CT.gov record has been observed for a new Pfizer Ph1 study evaluating multiple escalating oral doses of a novel compound PF-07081532 in T2DM patients and non-T2DM patients with obesity. Below, FENIX provides thoughts on this new trial in the context of oral GLP-1RA pipeline candidates from Pfizer and others.

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Thoughts on Intarcia’s Second CRL

The news of Intarcia receiving a second CRL for ITCA-650 (previous FENIX insight) brings about several thoughts and potential market implications. Below, FENIX provides its latest thinking in a favors/disfavors analysis about Intarcia, the GLP-1RA market, and a reminder that others in diabetes have received FDA approval after 2 CRLs.

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Senseonics Q4 ’19 Earnings Update

Senseonics hosted its Q4 ’19 earnings call (press release) and provided updates to its Eversense implantable CGM commercial and pipeline activities. Of note, the iCGM designation filing for the 90-day Eversense CGM is now anticipated in Q2 ’20. Below, FENIX provides highlights and insights from the call.

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Zealand Q4 ’19 Earnings Update

Zealand hosted its Q4 ’19 earnings call (press release) and provided updates to its diabetes business, including dasiglucagon and other pipeline assets. Of note, Zealand indicated that the dasiglucagon HypoPal NDA is on track for submission by the end of March 2020. Below, FENIX provides highlights and thoughts surrounding these updates.

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