Tag Archives: Diabetes

Novo launches “Defeat Diabetes” campaign; Diamyd Announces DiAPREV-IT 2 Topline Results; Senseonics Releases Android Remote Monitoring App

A series of diabetes-related news items have been observed: Novo Nordisk launched a new social responsibility campaign called “Defeat Diabetes”; Diamyd announced DiAPREV-IT 2 topline results; and Senseonics announced the launch of the Eversense NOW remote monitoring app for Android users. Below, FENIX provides highlights and insight for the respective news items.

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CREDENCE Once Again on the CHMP Agenda; CHMP Agenda May 25-28

The CHMP agenda for this month’s meeting (May 25-28) has been released, and it includes two notable items: the Invokana/Vokanamet renal protection indication (CREDENCE) and the Saxenda adolescent label extension. Of note, the May 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started on May 25. Below, FENIX provides diabetes-related highlights and insights from the May 2020 CHMP agenda.

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New Jardiance Post-MI HF Trial (EMPACT-MI)

BI/Lilly announced plans to conduct a new pragmatic trial, called EMPACT-MI, to investigate the effect of Jardiance on heart failure patients ±T2DM who have been hospitalized with an acute MI. The trial is being conducted in collaboration with the Duke Clinical Research Institute, and is being led by Adrian Hernandez and Javed Butler. A preliminary search of CT.gov did not show any results for EMPACT-MI, and BI/Lilly did not provide a timeline of when it plans to initiate the study. Below, FENIX provides thoughts on EMPACT-MI, including BI/Lilly’s motivation to conduct such a trial as well as potential readthrough to Farxiga.

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Medtronic Guardian Connect CGM Android Approval; Xeris PBH Ph2 Results; Capillary Biomedical Initiates Extended-wear Infusion Set Trial

Three diabetes-related news items have been observed today: Medtronic’s Guardian Connect is now compatible with Android, Xeris announced positive topline results from ready-to-use (RTU) glucagon in patients at risk of postprandial hypoglycemia following bariatric surgery, and Capillary Biomedical initiated a trial for its extended-wear infusion set. Below, FENIX provides highlights and insights from the respective news items.

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Medtronic CY Q1 ’20 (FY Q4 ’20) Earnings Update

Medtronic hosted its CY Q1 ’20 (FY Q4 ’20) earnings call and briefly discussed its diabetes business. Of note, Medtronic disclosed plans to launch a BLE-enabled 770G pump platform with remote updating functionality in the US ahead of the advanced hybrid closed-loop (AHCL) algorithm approval. Additionally, Medtronic will be presenting two AHCL data sets at the upcoming virtual ADA conference (June 12-16). Below, FENIX provides highlights and insights from the call.

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Thoughts on High-dose Trulicity Data

Late last week, Lilly announced that results from the AWARD-11 high-dose Trulicity trial had been published, with data showing up to -1.9% reduction in A1C and -10.4lb weight loss at 36 weeks with the 4.5mg dulaglutide dose (previous FENIX insight). Below, FENIX has conducted an AWARD-11 comparative analysis and provides thoughts on high-dose Trulicity in the context of Novo’s Ozempic and Lilly’s tirzepatide.

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Biocon Q1 ’20 (FY ’20) Earnings Update

Biocon hosted its CY Q1 ’20 (FY Q4 ’20) earnings call and provided brief updates on its biosimilar insulin development programs. Unsurprisingly, there were many analyst questions focusing on pricing strategy and interchangeability for bs-glargine, although Biocon’s senior management were reluctant to provide details. Below, FENIX provides highlights from the earnings call as well as brief thoughts on what approval for interchangeability in the US may look like.

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Zealand Q1 ’20 Earnings Update; Xeris Partners with Clinigen

Two diabetes-related news items have ben observed: Zealand hosted its Q1 ’20 earnings call and Xeris announced it has entered into an agreement with Clinigen for ex-US Gvoke distribution. Importantly, Zealand disclosed BI is now pursuing its GLP-1/GCG dual agonist (BI 456906) for NASH. Below, FENIX provides highlights and insights from the respective news items.

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Sanofi to Return Efpeg Rights To Hanmi

Sanofi has reportedly informed Hanmi of its intention to return efpeglenatide rights back to Hanmi. Hanmi noted that the two companies have 120 days to renegotiate the efpeglenatide deal at which point Hanmi said it may be open to taking legal action against Sanofi if needed. Below, FENIX provides insight into Sanofi’s decision, the potential impact on the efpeg development program, and why efpeg is still an attractive option for treating NASH/obesity.

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Semaglutide Ph3 Obesity Positive Topline Results (STEP 4)

Yesterday, Novo Nordisk announced positive results from the Ph3a STEP 4 trial evaluating the safety and efficacy of Semaglutide 2.4mg on body weight. Recall, STEP 4 is the first of the Ph3 semaglutide obesity program trials to read out. Below, FENIX provides an overview of the results as well as thoughts on potential readthrough to high-dose Ozempic.

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