Category Archives: Glucose Monitoring

J&J Q3 ’18 Earnings Update

J&J hosted its Q3 ’18 earnings call but only briefly discussed the Invokana franchise. Senior management did not comment on the CANVAS/R review which is anticipated this month. Recall, in July 2018, J&J announced FDA extended the CANVAS/R sNDA review by 3 months. Below, FENIX provides thoughts on the CANVAS review as well as potential read-through from Lilly’s Ph2b dual agonist results to J&J’s dual agonist, JNJ-64565111.

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AZ’s Head of CVRM Joins Novo

Novo Nordisk announced Ludovic Helfgott (pictured below), current global head of AZ’s CV, renal, and metabolism (CVRM), is joining Novo as the Executive VP of Biopharm. According to the press release, Helfgott will join Novo effective April 3, 2019 at which point Jesper Brandgaard, current head of Novo Biopharm and well-known former CFO, will retire. Below, FENIX provides thoughts on Helfgott’s appointment and potential future impact to Novo as well as an analysis of how the Biopharm position could help Helfgott’s career.

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Libre 2 With Real-Time Alerts/Alarms Approved in EU

Abbott announced it received CE Mark for the FreeStyle Libre 2, which now includes optional real-time alerts/alarms. Abbott said it will price Libre 2 at parity to the original Libre System and the company is planning an EU launch in the coming weeks. Abbott did not disclose its regulatory/commercial plans for the US; however, this remains a large market opportunity for the company and is anticipated in the coming months. Importantly, during Abbott’s EASD symposium, it was shown that the Libre 2 CE Mark approval includes the updated algorithm for overall 14-day accuracy at 9.5% MARD (US is 9.4%). Below, FENIX provides the key highlights and potential implications to the CGM market.

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New H2H Tresiba vs. “Lantus” CGM Crossover Study (SWITCH PRO)

A CT.gov record for a new Ph4 T2DM basal-only crossover study (SWITCH PRO) comparing Tresiba (U100) to “Lantus” has been observed. The study was likely named SWITCH PRO because of the crossover design and the use of Abbott’s Libre Pro blinded CGM. Below, FENIX provides thoughts on how Novo could leverage the study to augment its results from the previous SWITCH 1 and SWITCH 2 studies as well as context for the use of time-in-range as the primary endpoint to be first such trial included in the Tresiba label.

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One Drop Now Integrates with Apple Watch

One Drop announced its blood glucose management platform now integrates directly with the Apple Watch. Previously, One Drop’s Apple Watch app required users to manually input BG data. Below, FENIX provides thoughts on the One Drop/Apple Watch integration as a source of new patients for One Drop.

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Thoughts on New Non-Invasive CGM Data

Nemaura Medical announced positive results from an interim analysis of its SugarBEAT non-invasive CGM study. According to the press release, Nemaura plans to launch SugarBEAT in the UK “in the coming months” with FDA fling scheduled for Q1 ’19. Below, FENIX provides thoughts on the potential impact of a non-invasive option for CGM.

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Livongo-Abbott Integration with Libre Pro

Livongo announced a partnership with Abbott to integrate the FreeStyle Libre Pro into the Livongo for Diabetes program. The integration with a professional (retrospective) CGM makes sense given Livongo’s focus on patient education and behavior-based treatment. Below, FENIX provides a unique perspective that the Abbott partnership could signal a limitation in Livongo’s diabetes solution.

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Senseonics Partners with Beyond Type 1 for Patient Awareness/Education

Senseonics and Beyond Type 1 announced a collaboration to make the Eversense implantable CGM the “worldwide presenting sponsor of the Type One Run.” Beyond Type 1 is a patient advocacy organization primarily focused on providing patient education and resources through social media. Below, FENIX provides perspective on the partnership opportunity for Senseonics.

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Medtronic Guardian Sensor 3 CGM Now Integrated with 630G

Medtronic has started notifying HCPs that its 630G sensor augmented pump (SAP) with low glucose suspend is now available with the Guardian Sensor 3 CGM. This is the same sensor that is being used with the 670G hybrid closed-loop as well as the standalone Guardian Connect CGM system. Medtronic did not issue a press release on the new 630G/Guardian Sensor 3 integration. Below, FENIX provides observations and thoughts on the upgraded sensor integration.

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Dexcom Acquires TypeZero

Dexcom announced it has acquired TypeZero. Recall, TypeZero has developed a proprietary inControl algorithm for insulin dose adjustments. The acquisition is viewed as highly positive for both sides: Dexcom gains future revenue streams and IP while TypeZero investors are able to exit with a presumably attractive return. Below, FENIX provides insight into the acquisition.

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