Tag Archives: Announcements

Senseonics Launches Eversense Implantable CGM

Senseonics has announced the official US launch of the Eversense CGM as well as its first commercial coverage by Horizon BCBS of New Jersey and Horizon Healthcare of New Jersey. According to the press release, product shipments began the last week of July. Tomorrow, August 8, 2018, Senseonics is holding its Q2 ’18 earnings call and will likely provide more insight into the Eversense launch.

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Lilly’s New Diabetes Helpline to Aid Insulin Access

Lilly announced the availability of its new “Lilly Diabetes Solution Center helpline” to assist patients in finding appropriate programs to make insulin treatments more affordable. Below, FENIX provides insights about the new Lilly program in the context of patient need and other savings programs from large insulin manufacturers.

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J&J Q2 ’18 Earnings Update

J&J hosted its Q2 ’18 earnings call and provided brief updates on its diabetes business. Importantly, senior management did not make any comments regarding the early stopping of the CREDENCE study or the delay in the CANVAS/R CV indication. Below are highlights from the Q2 2018 J&J earnings call.

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Thoughts on CeQur/Calibra Acquisition and T2DM Patch Pump Market

CeQur announced it has acquired global rights to commercialize the OneTouch Via patch pump. CeQur’s interest in OneTouch Via is curious since CeQur has developed its own patch pump (PaQ). According to the press release, CeQur plans to launch the OneTouch Via (branded under a new, undisclosed name) in mid-2019. Below, FENIX provides thoughts on whether CeQur will commercialize both devices as well as insight into the T2DM pump market.

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Thoughts on Beta Bionics and Implications to Stable Glucagon, Senseonics, and Fiasp

Beta Bionics has initiated (press release) their home-use clinical trial (CT.gov record)of an insulin-only iLet AP system. Additionally, Ed Damiano, Beta Bionic’s CEO, presented at the Friends For Life conference and provided an update on the iLet commercial device. Below, FENIX provides analysis of the iLet study as well as implications to the glucagon market.

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“Smart CGM is a new category” – Medtronic ADA 2018 investor event summary

In conjunction with the ADA 2018 congress, Medtronic hosted an investor event (slide presentation) and the diabetes senior management team provided additional insights into their evolving business philosophy beyond the June 5 investor day. Below, FENIX provides a summary of the investor event, which had a large amount of news, as well as analysis behind Medtronic’s deliberate strategic choice to compete near-term in CGM features and solutions vs. hardware convenience.

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ADA ’18 Key Data Press Releases (June 24)

4 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs and devices. Below, FENIX has provided context and analysis of these announcements.

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New Novo CVOT strategy; ADA ’18 Analyst Briefing

Novo hosted its annual ADA analyst briefing (presentation slides), predominantly discussing oral semaglutide. Of note, Novo disclosed they are no longer conducting a large-scale CVOT for Ozempic (formerly SOUL), instead leveraging the results of both SUSTAIN 6 and PIONEER 6 between injectable and oral semaglutide. Novo senior management said they believe it will be difficult for PIONEER 6 to demonstrate CV benefit at p < 0.05 given the low number of pre-specified events will require a large reduction in the hazard ratio. Additionally, Novo stated they plan to file oral semaglutide in mid-2019. Below are highlights from the ADA analyst event including three potential scenarios for injectable and oral semaglutide CV indications.

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Drug ADA ‘18 Key Data Press Releases (June 23)

21 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs, devices, and apps, a major increase from 9 on the first day of ADA ‘17. Below, FENIX has provided context and analysis for 14 drug-related announcements, with analysis of device and app-related announcements to follow in a separate alert.

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