Tag Archives: Fenix Analysis

New Fiasp/Medtronic 670G Study on CT.gov

A CT.gov record for a study evaluating Novo’s Fiasp (faster-acting insulin aspart) in a Medtronic 670G pump has been observed. This Ph4 study is sponsored by Bruce Buckingham’s lab at Stanford, and Medtronic is listed as a collaborator (Novo is not believed to be part of the study). Recall, the Fiasp label does not include designation for use in insulin pumps. Below, FENIX provides insight into the use of ultra-rapid-acting insulin in pumps as well as why a future commercial partnership between Novo and Medtronic could make sense.

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CGM Swapping Supported by Senseonics/Beta Bionics Partnership

Senseonics and Beta Bionics announced a new collaboration to integrate the Eversense implantable CGM with the iLet bionic pancreas. Below, FENIX analyzes the collaboration including statements from the companies that suggest iCGM systems can be switched between closed-loop systems.

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FENIX Analysis: Post-AACE 2018 Device Promotional Material

In the second installment of our post-AACE 2018 promotional material coverage (see first installment on diabetes drugs), FENIX has conducted an analysis of diabetes device promotional materials covering Dexcom G6, Abbott Freestyle Libre, Medtronic 670G, Insulet Omnipod, and Tandem t:slim X2.

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FENIX Analysis: Post-AACE 2018 Drug Promotional Material

In advance of ADA 2018 beginning June 21, FENIX has conducted a comprehensive analysis of new and recent promotional materials obtained at AACE 2018. Notably, this was the first major conference opportunity for Novo to promote both Ozempic and the Tresiba DEVOTE label update.

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FENIX Analysis: SGLT2i HF CVOTs and Stopping Early Scenarios

Currently, there are multiple ongoing, label-enabling HF CVOTs in the SGLT2i class for Jardiance, Farxiga, and Zynquista (sotagliflozin), along with other studies exploring surrogate endpoints, biomarkers, and mechanisms of action. FENIX has created a tale-of-the-tape summary of the SGLT2i HF CVOTs along with a projected timeline for filings and launches. In summary, it is believed that AZ’s DAPA-HF CVOT has a high probability of stopping early for overwhelming efficacy and thus creating a priority review scenario to leap AZ ahead of BI/LLY by 6-12 months in this important LCM opportunity. Below is a summary of the rationale and hypothesis comparing the different development approaches by SGLT2i sponsors to improve clinical outcomes in HF patients.

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Thoughts on Novo PRV importance to oral semaglutide

During Novo’s Q1 ’18 London earnings webcast, senior management discussed potential scenarios surrounding the recently-purchased priority review voucher (PRV), including its use for either oral semaglutide or a semaglutide obesity indication. Below, FENIX provides its thoughts on how the PRV serves as insurance to a successful launch for oral semaglutide, as well as some anticipated triggers for its usage.

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New Novo CMO?

Novo Nordisk has announced its participation in the Hypo-RESOLVE research project. FENIX has made a curious observation based on the press release, which references Stephen Gough as Novo’s “Global Chief Medical Officer in Denmark.” This position was believed to be held by Alan Moses.

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Livongo Acquires Digital Obesity Company

Livongo announced it has acquired Retrofit, a Chicago-based digital solutions company focusing on weight management and diabetes prevention. Livongo’s expansion into the obesity digital health market is the next logical step for the company as it seeks to provide a more holistic solution. Below, FENIX provides analysis of the Retrofit acquisition.

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Common Sensing and Haselmeier Thoughts

Common Sensing announced close of $6.6M in Series A funding. Of note, Haselmeier joined this funding round as a new investor along with other venture capital firms which is curious since Haselmeier is an injection delivery device engineering company.

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Mylan IR Day Highlights; Biosimilar Victoza and Toujeo in Development

Mylan hosted its Investor Day and provided updates on biosimilar Lantus and Novolog, as well as disclosing for the first time its intentions to develop biosimilar versions of Toujeo, Victoza, and Saxenda. Below, FENIX provides analysis and market implications for each of the biosimilar programs.

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