Tag Archives: Fenix Analysis

Thoughts on CREDENCE

CREDENCE was recently stopped early, bringing a multitude of thoughts and potential implications to the diabetes market. Below, FENIX provides deep, rich analysis on the potential results of CREDENCE, the possibility for CREDENCE to be in a combined FDA review with CANVAS/R, market and label implications, read-through to DECLARE, and how ARB history seems to be repeating itself with SGLT2i.

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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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Thoughts on New Sanofi/Verily Connected Care Pre-filled T2DM Pump Partnership

With Sanofi and Verily’s recent Sensile Medical partnership for a connected pre-filled patch pump (Sensile website), FENIX has conducted an analysis of Sanofi’s connected care strategy with market, manufacturing, and payer implications. Below, FENIX provides insight into the diabetes connected care landscape in the context of the large insulin manufacturers (Sanofi, Novo, and Lilly).

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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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More Thoughts on PIONEER-4 and Potential Novo Regulatory Strategy for Oral Semaglutide

For the four Ph3a oral semaglutide trial data disclosures thus far, Novo has consistently discussed two statistical analyses performed: on-treatment and intention-to-treat. FENIX believes this directly plays into Novo’s oral semaglutide regulatory strategy including preparing for an FDA adcom, the submission dossier, and proposed product label. Below, FENIX discusses more thoughts in the context of the PIONEER-1 study and potential label implications from Novo’s statistical representations that could allow for PIONEER-4 superiority vs. Victoza in the label.

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Novo Suspends Ph1 Stable Glucagon Analog Study

The CT.gov record for Novo’s Ph1 stable glucagon analog study (NN9030) has been updated, and the trial is now listed as “Suspended (Evaluation of data).” Below, FENIX provides potential scenarios for the recruitment suspension.

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Voluntis and Monarch Medical Partnership Will Compete with Glytec

Voluntis and Monarch Medical Technologies have announced a strategic collaborationto integrate Voluntis’s personal T2DM diabetes platform (Insulia) with Monarch’s in-patient insulin titration tools (EndoTool IV and EndoTool SubQ). Below, FENIX provides insight into the collaboration including perspective on competition to Glytec who provides a similar product.

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GlySens Implantable CGM Trial Completed

The FIGS-2 trial for GlySens’s implantable CGM, Eclipse, has completed according toCT.gov- two and a half years after the originally scheduled completion date of December 2015. The primary endpoint of the 20-subject study was adverse events. FENIX has conducted a headwinds/tailwinds analysis of the Eclipse system in the context of the larger CGM market.

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Montreal dual-hormone AP System: Implications to Closed-Loop Development

A Montreal-based research group presented data at ADA on a dual-hormone artificial pancreas using both insulin and pramlintide. The study, presumed to be the clinical trial MAP-1, showed significantly improved glucose levels compared to an insulin-only artificial pancreas. Below, FENIX has provided context and insight regarding this study and its potential implications to the AP development space.

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