Category Archives: Bolus Insulin

Lyumjev (ultra-rapid lispro) Label Analysis and Supply Conversion Thoughts

June 23, 2020

Last week, FDA approved Lilly’s ultra-rapid lispro as “Lyumjev,” pronounced [LOOM-jehv] as the second ultra rapid-acting injectable insulin behind Novo’s Fiasp. Of note, the generic name for Lyumjev is lispro-aabc. Below, FENIX provides an in-depth Lyumjev label analysis, including a comparison with Novo on RAI supply conversion strategy, and potential insights into Lilly’s connected pen solution.

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Xeris Ph2 Pramlintide+insulin Co-formulation Topline Results

Xeris Pharmaceuticals announced positive topline results from a Ph2 trial evaluating its pramlintide-insulin co-formulation (XP-3924). Xeris said it is planning for an end-of-Ph2 meeting with FDA later in 2020 to discuss the XP-3924 development path. Below, FENIX provides an overview of the topline results as well as thoughts on the market potential of XP-3924 in the context of other similar products, notably Adocia’s ADO09 (M1pram).

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Dapa Reduces Progression to T2DM; Teplizumab Continues to Delay T1DM Onset; Arecor AT247 Faster than Fiasp; ADA Key Press Releases (June 15)

Today, twelve diabetes-related news items were observed: DAPA-HF delays T2DM onset, teplizumab follow-up results, Arecor uRAI Ph1 data, new Afrezza practical data, Diasome HDV Ph2 results, Hua Medicine Ph3 GKA data, ORMD-0801 in NASH, Glytec CGM POC data, Biolinq’s first-in-human CGM data, and more. Below, FENIX provides context and analysis for the announcements.

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Lilly’s Lyumjev FDA Approved (ultra-rapid lispro)

Today, FDA posted a label for Lyumjev (ultra-rapid lispro) in the Drugs@FDA database ahead of a Lilly press release (see direct link here to the label in PDF). FENIX will have a full label analysis in the coming days.

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Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE at ADA 2020; Sota T2DM CKD Data; vTv Presents TTP399 Ph2 Results; ADA 2020 Key Press Releases (June 13)

Today, nine diabetes-related news items were observed: Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE data were presented at ADA 2020 as well as new data from Lexicon (sota T2DM Ph3 CKD), vTv (Ph2 Simplici-T1), and Zealand (V-Go patch pump). Below, FENIX provides context and analysis for the announcements.

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New MPD Insulin Savings Program Supported by Lilly, Novo, and Sanofi

Yesterday, President Trump announced a new plan to reduce the monthly cost of insulin to no more than $35 for people on Medicare Part D. The plan, which is scheduled to go into effect on January 1, 2021, is being supported by Lilly, Novo Nordisk, and Sanofi. Following the announcement, Lilly’s CEO, Dave Ricks, issued a statement lauding the new savings model, saying it “fills a critical gap that remained in the system.” Below, FENIX provides thoughts on the new plan in the context of the overall US drug pricing debate.

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Novo launches “Defeat Diabetes” campaign; Diamyd Announces DiAPREV-IT 2 Topline Results; Senseonics Releases Android Remote Monitoring App

A series of diabetes-related news items have been observed: Novo Nordisk launched a new social responsibility campaign called “Defeat Diabetes”; Diamyd announced DiAPREV-IT 2 topline results; and Senseonics announced the launch of the Eversense NOW remote monitoring app for Android users. Below, FENIX provides highlights and insight for the respective news items.

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Biocon Q1 ’20 (FY ’20) Earnings Update

Biocon hosted its CY Q1 ’20 (FY Q4 ’20) earnings call and provided brief updates on its biosimilar insulin development programs. Unsurprisingly, there were many analyst questions focusing on pricing strategy and interchangeability for bs-glargine, although Biocon’s senior management were reluctant to provide details. Below, FENIX provides highlights from the earnings call as well as brief thoughts on what approval for interchangeability in the US may look like.

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Updated Perspective on Nemaura’s CGM; Lifescan and Noom Collaboration; Dario Q1 ’20 Earnings Update

Several diabetes-related news items have been observed: Nemaura Medical’s CEO provided an interview regarding the company’s H2H CGM study, saying that the CGM used was Abbott’s Libre, Lifescan announced a partnership with Noom to pilot a digital diabetes and weight loss management program, and DarioHealth hosted its Q1 ’20 earnings call. Below, FENIX provides updated perspective on Nemaura’s CGM in light of the recent CEO interview, thoughts on the Lifescan/Noom collaboration, and highlights from the Dario earnings call.

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Novo Q1 ’20 Earnings Roadshow; Xeris, Teva, and BD Earnings Updates

Novo Nordisk hosted its post-Q1 ’20 earnings roadshow event. Additionally, Xeris, Teva, and Becton Dickinson held their respective Q1 ’20 earnings calls. Teva did not discuss its generic liraglutide nor did BD discuss the status of its T2DM patch pump. Below, FENIX provides highlights and insights from the respective earnings calls.

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