Tag Archives: Semglee

JPM 2021 Day 4: Lexicon Poised for a Strong Comeback; Lexicon, Viatris, and Intercept @ JPM; Poxel/Metavant Partnership Terminated

On the final day of JPM 2021, FENIX has provided coverage of presentations by cardiometabolic companies including Lexicon, Viatris, and Intercept. Additionally, two separate cardiometabolic-related news items have been observed: Lexicon announced it received FDA feedback stating SOLOIST and SCORED results support a sotagliflozin NDA submission for a broad HF indication; and Poxel/Metavant announced the termination of their partnership. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage, including Lexicon’s proposed broad HF label for sotagliflozin and Viatris’s biosimilar Toujeo.

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Novo to Acquire Emisphere Technologies; Mylan Q3 ’20 Earnings Update

Two diabetes-related news items have been observed: Emisphere Technologies announced it is being acquired by Novo Nordisk for $1.35B ($7.82/share) and Mylan announced its Q3 ’20 earnings update. Below, FENIX provides thoughts on Novo’s acquisition of Emisphere and potential catalysts behind the acquisition, including oral peptide delivery development beyond semaglutide.

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Biocon CY Q3 ’20 (FY Q2 ’21) Earnings Update

Biocon hosted its CY Q3 ’20 earnings call (FY Q2 ’21) and provided updates to its biosimilar insulin portfolio. Unsurprisingly, much of the call was focused on COVID-19 treatments and the US Semglee (biosimilar glargine U100) launch. Of note, there was no mention of the biosimilar lispro or oral insulin tregopil programs. Below, FENIX provides highlights and insights from the call, including an analysis of the US Semglee weekly NRx.

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Biocon/Mylan Launch Semglee in US at 65% WAC Discount to Lantus

Biocon/Mylan announced the US launch of its Semglee 10mL vials and pre-filled pens (glargine U100) at a 65% discount to Lantus. According to Biocon/Mylan, the WAC for a package of 5 x 3mL pens is $147.98 and a 10mL vial is $98.65. Interestingly, Biocon/Mylan said the Semglee pen price matches the Lantus 2007 WAC and the Semglee vial list price matches the Lantus 2010 price. Below, FENIX provides a comparative pricing analysis across the basal insulin market, the Semglee launch implications to Sanofi and Lilly, and thoughts on how the Biocon/Mylan strategy may impact other bs-glargine manufacturers (e.g. Sandoz/G&L and Lannett/HEC).

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Mylan Filed for Glargine Interchangeability; Insulet, Mylan, and BD Q2 ’20 Earnings Updates

Mylan (press release; slides), Insulet (press release), and Becton Dickinson (press release; slides) hosted their respective Q2 ’20 earnings calls. Of note, Mylan disclosed it has submitted “all necessary documentation to seek biosimilar interchangeability [for Semglee]” as well as a BLA for its bs-aspart with FDA. Below, FENIX provides highlights and insights from the respective earnings calls.

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Biocon/Mylan Bs-glargine Approved; Novo to Acquire Corvidia; Lifescan Launches Verio Reflect; Lannett FDA Bs-glargine Meeting; Medtronic 780G CE Mark; Dexcom Launches G6 Pro; ADA ’20 Key Data and Partnership Press Releases (June 11)

Ahead of the ADA 2020 conference start, a series of diabetes-related press releases have been observed: Biocon/Mylan received FDA approval for its bs-glargine, Novo Nordisk is set to acquire Corvidia, Lannett provided an update on its meeting with FDA for bs-glargine, LifeScan launched the Verio Reflect BGM, Medtronic received CE Mark for the 780G system, Dexcom launches G6 Pro, and DarioHealth entered into new partnership agreements. Below, FENIX provides context and analysis for the announcements.

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