Category Archives: Topics

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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New Medtronic IQcast Feature And Adocia RAI iLet Trial

Yesterday, Medtronic announced a hypoglycemia prediction feature called “IQcast” for the Sugar.IQ personal diabetes assistant app while Adocia announced the initiation of an AID trial evaluating BioChaperone Lispro and other RAI using the Beta Bionics’ iLet closed-loop system. Below, FENIX provides additional thoughts on each of the topics. Medtronic launches ‘IQcast’ hypo prediction feature for Sugar.IQ users According to the press release, IQcast can predict the likelihood of a hypoglycemia event anywhere between 1-4 hours in advance. This news is in-line with previous guidance from Medtronic indicating its intentions to extend the predictive alert time of Guardian Connect up to 4 hours. Of note, Medtronic denoted……

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New Novo Ph1 Combo Study of QW Insulin 287 + Ozempic

Last week, Novo Nordisk initiated a new Ph1 trial evaluating its QW basal insulin analog, Insulin 287, as a fixed-ratio combination with Ozempic in T2DM patients. Below, FENIX provides additional thoughts on the new Novo combo study and the potential for Lilly and Sanofi to develop next-gen fixed-ratio products in the GLP-1RA+basal insulin class. The initiation of this Ph1 trial indicates that Novo is considering developing the QW fixed-ratio GLP-1RA+basal combination. The market opportunity for a QW basal insulin seems a bit unclear due to hypo concerns; thus it may not be practical in T1DM. Presumably, as part of its franchise market forecast for the QW basal insulin, a GLP-1RA+basal fixed-ratio combo……

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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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Thoughts on 2019 ADA Standards of Care

The ADA announced the publication of their 2019 Standards of Medical Care in Diabetes Care. Of note, the ADA has aligned their CVD recommendations with the ACC’s recent T2DM ASCVD recommendations. The ADA also added a new dedicated section titled “Diabetes Technology,” which includes information previously incorporated in the “Glycemic Targets” section. The ADA also provides a cost breakdown of pharmacologic treatment options. Below, FENIX has provided highlights and insights from the updated ADA 2019 Standards of Care.

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Onduo-Walgreens T2DM strategic partnership

Yesterday, Verily announced a strategic partnership with Walgreens Boots Alliance (WBA) to improve health outcomes for patients with chronic conditions, including diabetes. Of note, WBA is Verily’s first retail pharmacy development and commercialization partner. Below, FENIX provides additional thoughts on this partnership in relation to Sanofi/Verily’s joint venture ‘Onduo’ and Dexcom. According to the press release, Verily and WBA will focus on developing a medication adherence pilot project that will utilize devices and other approaches to improve adherence. Under this collaboration, Walgreens and Onduo will launch a “Virtual Diabetes Program” through the Walgreens employee health plan to those with T2DM. This service will include coaching and remote access to specialty care services. The financial……

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Lilly 2019 Guidance Summary

Today, Lilly hosted its 2019 Guidance and Investment Community Meeting and discussed potential key milestones for 2019. Importantly, Lilly announced late stage development plans in obesity and NASH and provided more information on the Ph3 dose titration for its QW injectable GIP/GLP-1 dual agonist tirzepatide. Connected care was also featured, and several comments were made on guidelines updates and new PBM coverage positively affecting Trulicity and Jardiance in 2019. Below, FENIX provides a summary and thoughts on diabetes-related highlights from the event. 

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Gan and Lee + Sandoz and FDA Biosimilar Insulin BLA List

Today, Sandoz announced it has in-licensed the biosimilar insulin portfolio of Gan & Lee for commercialization of glargine, aspart, and lispro. Last week, FDA published a Q&A document and a list of biologics that will convert from NDA to BLA under the US BPCI Act of 2010, which include insulin products. Below, FENIX briefly provides thoughts on each topic.

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Intarcia re-filing mid-2019

Yesterday, Intarcia announced a corporate update, where the main news was that it intends to re-submit the ITCA-650 NDA in “mid-2019”. The announcement also quoted its three new senior team members, including Fred Fiedorek as Chief Medical Officer and Head of Regulatory (previous FENIX insight), Thane Wettig as Chief Marketing Officer (previous FENIX insight), and Anders Vinther as Global Head of Quality & Engagement. Intarcia’s 2017 CRL was well-publicized (previous FENIX insight), but Intarcia has seemingly been given a path to re-filing “…after several consultations with the FDA during 2018…”. If Intarcia re-files in June, it should have a PDUFA date……

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