Category Archives: Other

Diabetes Takes a Backseat During Part II Drug Pricing Hearing

Today, the Senate Finance Committee held the second drug pricing hearing of 2019 (Drug Pricing in America: A Prescription for Change, Part II). Part I was held on January 29, 2019. While the Part I drug pricing hearing spent much time discussing insulin pricing, diabetes-specifically was hardly mentioned. When a specific drug was mentioned, it was most often AbbVie’s Humira. Below, FENIX provides diabetes-related highlights and insights from the hearing.

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Farxiga eGFR Cutoff Lowered; Positive Brilinta T2DM Data

AstraZeneca’s Farxiga franchise labels (Farxiga and Xigduo) have been updated to reduce the eGFR cutoff from 60 to 45 mL/min/1.73m2. Additionally, AZ announced positive topline results from the Brilinta Ph3 THEMIS study in patients with established CAD and T2DM. Below, FENIX provides insight into the lower Farxiga eGFR as well as thoughts on AZ’s strengthening CV protection market position.

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Thoughts on New Hygieia d-Nav Mobile App for Insulin Titration; New Data published in The Lancet

Hygieia recently announced it received 510(k) clearance for a mobile app that is part of the company’s d-Nav insulin guidance service. Recall, d-Nav is a T2DM-focused, cloud platform that provides personalized insulin dose recommendations based on the user’s BGM values. Additionally, results were published in The Lancet for a study showing d-Nav plus HCP support led to superior glycemic control than with HCP support alone. Below, FENIX provides thoughts on how Hygieia’s d-Nav and other similar systems could impact the diabetes market.

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Lilly to use PRV for REWIND? Novo Q4 ’18 London earnings update

Novo Nordisk hosted its post-Q4 ’18 earnings event in London. The session included a brief presentation from management followed by Q&A which primarily focused on Novo’s priority review voucher (PRV) for oral semaglutide. Below, FENIX provides highlights and analysis from the call, as well as the scenario that Lilly could use its PRV for REWIND to keep pace with Novo.

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Merck Q4 ’18 Earnings Update

Merck held its Q4 ‘18 earnings call and briefly discussed its diabetes portfolio. Of note, Merck’s earnings press release highlighted the recent in-licensing of NGM313, renamed MK-3655 (monoclonal antibody agonist of the β-Klotho/FGFR1c receptor), which is being evaluated in T2DM and NASH. Additionally, senior management announced that the company will hold an investor event on June 20, 2019 to provide an update on Merck’s strategic progress and its plans for the future. Below are highlights from the call.

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Livongo Acquires Behavioral Health Company

Livongo announced its intention to acquire myStrength, a Colorado-based behavioral health company focused on chronic conditions including depression, anxiety, stress, substance use disorder, chronic pain, opioid addiction and recovery, and insomnia. Below, FENIX provides insight into the acquisition including thoughts on how Livongo may be leveraging myStrength to expand Livongo’s core diabetes business.

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Oramed Initiates Ph1 Oral GLP-1RA; Zafgen and vTv Ph2 data

Oramed has initiated its first ORMD-0901 (oral GLP-1RA) Ph1 study under its FDA IND application. Additionally, Zafgen and vTv Therapeutics recently announced data from their respective Ph2 programs for ZGN-1061 (MetAP2 inhibitor) and TTP399 (glucokinase activator). Below, FENIX provides an overview of the Oramed Ph1 study, Zafgen and vTv Ph2 data, and thoughts the viability of each program in the antihyperglycemic market. Oramed Ph1 Oral GLP-1RA initiation Oramed announced the initiation of its first Ph1 study under their FDA IND application. Recall, The IND was granted in September 2018. According to the press release, the Ph1 trial is a randomized, single-blinded crossover……

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New Afrezza TV DTC campaign on Jan 14, 2019

Today, MannKind hosted a business update call and provided guidance on Afrezza commercialization and their financial position. MannKind held this call as they are not presenting at the upcoming JPM healthcare conference (Jan 7-10, 2019). Of note, management indicated it has increased its consumer focus on Afrezza to drive greater uptake in 2019 by launching an Afrezza TV DTC campaign on January 14, 2019. Additionally, the company commented on CGM market penetration as a potential growth driver for Afrezza in 2019 and beyond. Below, FENIX provides diabetes-related highlights from the call. Afrezza TV DTC– On January 14, 2019, MannKind plans to launch an Afrezza TV DTC……

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Happy Holidays from FENIX!

This holiday season, we genuinely thank you for your readership to our FENIX news updates. In the year 2018, we successfully shared 350+ updates on the most current diabetes news with impactful market insights using our deep thought leadership. We look forward to another successful year in 2019. Have a safe and happy holiday break! Warm regards, FENIX Team :)… If you receive our email blasts, you already have an account. Log in nowContext counts when making decisions.Purchase Blast$599.00You can read the article’s full content online after purchase. About The Author Matthew Maryniak | President of Fenix Group International Matthew…

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LX2761 positive Ph1 topline results and JDRF’s 2018 T1D research developments

Yesterday, Lexicon announced positive topline results from their Ph1 studies of oral SGLT1i ‘LX2761’ and JDRF announced its overall T1DM research developments from 2018. Below, FENIX provides additional thoughts on each topic. LX2761 Ph1 topline results LX2761 Ph1 topline results contained data from two studies, including a Ph1a single ascending-dose study in healthy, T2DM patients and a Ph1b multiple ascending-dose study in T2DM patients. The timing of this announcement is aligned with guidance from Lexicon’s Q3 ’18 earnings call, which indicated topline results by YE ’18 (previous FENIX insight). Notably, a brief CT.gov search for Lexicon’s LX2761 Ph1 studies did not show……

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