Category Archives: Bolus Insulin

Sanofi Discontinues 2 Dual-Agonist Programs; Q4 ’18 Earnings Update

Today, Sanofi hosted its Q4 ’19 earnings call, provided updates to its diabetes business, and disclosed that it discontinued SAR425899 (GLP-1/GCGR) and SAR438335 (GLP-1/GIP) for the treatment of obesity in T2DM and T2DM, respectively. Of note, Sanofi’s CEO will be testifying at the February 26, 2019 Senate Committee hearing on drug pricing. Below, FENIX provides highlights from the call as well as thoughts on Sanofi’s position in diabetes, obesity, and NASH.

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No REWIND PRV Mentioned; Lilly Q4 ’18 Earnings Update

Lilly hosted its Q4 ’18 earnings call and provided brief updates to its diabetes business including its REWIND outlook, Jardiance tailwinds, URLi regulatory filing, and CAROLINA topline results. Of note, Lilly discontinued development of the Ph2 DACRA-042 compound from KeyBioscience. Below, FENIX provides highlights and analysis from the call.

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Novo to File Oral Sema with PRV; Q4 ’18 Earnings Update

Novo Nordisk hosted its Q4 ’18 earnings call and disclosed that it will use its priority review voucher (PRV) for the oral semaglutide US filing by the end of Q1 ’18. Of note, Novo is planning to file for Ozempic and oral semaglutide CV indications based on the results from SUSTAIN 6 and PIONEER 6 despite PIONEER 6 not achieving statistical significance for 3P-MACE. Below, FENIX provides highlights from the earnings call, additional insight on the semaglutide regulatory strategy, and thoughts on why Novo likely wants an oral semaglutide adcom.

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Lilly Repeatedly Called Out During US Senate Hearing on Drug Pricing

Today, the Senate Finance Committee held the first hearing of 2019 and it highlighted US drug pricing (Drug Pricing in America: A Prescription for Change, Part I). A majority of the 3-hour discussion focused on Medicare Part B and D, Medicaid best pricing, 340B incentives, and diabetes insulin pricing in particular. Of note, when insulin was discussed, it was largely in the context of Lilly and Humalog with no mention of Novo or Sanofi. Below, FENIX provides diabetes-related highlights from the hearing and thoughts on the national discussion on drug pricing.

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Biocon CY Q4 ’18 (FY Q3 ’19) Earnings Update

Biocon hosted its CY Q4 ’18 (FY Q3 ’19) earnings call and briefly discussed its biosimilar insulin program including bs-glargine and rh-insulin. Below, FENIX provides highlights from the call as well as additional perspective on Mylan’s upcoming bs-glargine commercialization following the 30-month stay (March 2020).

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Thoughts on Afrezza Direct Purchase Program

MannKind recently announced a new direct purchase program for Afrezza, offering the drug for as little as $4/day for the first 1000 patients who sign up for the program through http://www.insulinsavings.com. Additionally, MannKind said it is launching an enhanced $15 copay card program; however, the copay card website does not appear to have been updated as of yet. Below, FENIX provides thoughts on the Afrezza program, an RAI pricing analysis, and insight how the program may help drive payer coverage. Afrezza direct purchase program details The Afrezza direct purchase program allows the first 1000 patients a $120 introductory price for 90……

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JPM 2019 Day 2: LLY, SNY, LXRX, ABT, PODD, MYL

The second day of the 2019 J.P. Morgan Healthcare conference included diabetes-related presentations from Lilly, Sanofi, Lexicon, Mylan, Abbott, and Insulet. Separately, Lilly announced plans to further increase drug pricing transparency using Trulicity TV DTC. The commercials will include a portion directing patients to a Lilly website for more information on list price and average copays. Below, find a topline summary of key JPM takeaways by company followed by more in-depth coverage. In case you missed it, here is a link to FENIX’s Day 1 JPM 2019 insights. Lilly Lilly’s CEO provided a brief introduction to the company and referenced the……

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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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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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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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