Tag Archives: Ozempic

Novo Q2 ’20 Roadshow; Provention Bio Q2 ’20 Earnings Update; Senseonics Eversense Covered by Highmark

Novo Nordisk hosted its post-Q2 ’20 earnings roadshow event (see previous FENIX insight on Q2 ’20 Novo earnings from August 6). Additionally, Provention Bio hosted its Q2 ’20 earnings call yesterday (press release), and Senseonics announced a positive coverage decision for its implantable CGM from Highmark. Below, FENIX provides highlights and insights from the respective news item and earnings calls.

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Novo Discontinues its Dual/Triple Agonists for Obesity; Novo Q2 ’20 Earnings Update

Novo Nordisk hosted its Q2 ’20 earnings call (press release; slides) and provided updates to its diabetes, obesity, and NASH clinical and commercial activities, but much of the discussion was focused on Novo’s obesity portfolio. Importantly, Novo disclosed it has discontinued the development of its dual and triple agonists for the treatment of obesity following positive results from the recent semaglutide and AM833 data disclosures (semaglutide Ph3 STEP, Ph2 AM833, and Ph1 sema+AM833). Additionally, FENIX includes context from Novo’s invite-only R&D event on June 19 (view slides here). Below, FENIX provides highlights and insights from the call, including why it makes sense Novo would use its PRV for semaglutide in obesity.

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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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Semaglutide Ph3 Obesity Positive Topline Results (STEP 4)

Yesterday, Novo Nordisk announced positive results from the Ph3a STEP 4 trial evaluating the safety and efficacy of Semaglutide 2.4mg on body weight. Recall, STEP 4 is the first of the Ph3 semaglutide obesity program trials to read out. Below, FENIX provides an overview of the results as well as thoughts on potential readthrough to high-dose Ozempic.

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Semaglutide Positive Ph2 NASH Data; Novo Q1 ’20 Earnings Update

Novo Nordisk hosted its Q1 ’20 earnings call (press release; slides) and provided updates to its diabetes business including the ongoing launch of Rybelsus (oral semaglutide) and new Ph2 semaglutide NASH topline data. Unsurprisingly, much of the Q1 ’20 prepared remarks and Q&A were focused on NASH. Below, FENIX provides highlights from the call and additional thoughts on Novo’s PCSK9i/basal insulin hybrid approach.

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FENIX Analysis: Ozempic and Trulicity CV Indication Initial Promotion

Novo Nordisk and Lilly have updated their Ozempic and Trulicity HCP websites with new messaging for their respective CV protection indications. Below, FENIX provides an initial HCP website promotional analysis, which includes insight into how the differences in the respective indications could potentially blur HCP perceptions of the Ozempic and Trulicity brands.

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New Ozempic Switching Study from other GLP-1RA (SUSTAIN SWITCH)

A new CT.gov record for a high-dose semaglutide switching study (SUSTAIN SWITCH) has been observed. In the study, patients will switch from their existing GLP-1RA therapy (not injectable semaglutide) to subcutaneous QW semaglutide (either 0.25 or 0.5mg starting dose) and titrate up to 2.0mg sema. Below, FENIX provides an overview of SUSTAIN SWITCH as well as insight into how Novo Nordisk may leverage the study to pre-emptively position Ozempic vs. Lilly’s tirzepatide.

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Thoughts on Ozempic CV Indication and Rybelsus Data-on-label

Novo Nordisk announced the FDA approval for the Ozempic CV protection indication while Rybelsus only received data-on-label. Recall, Novo separately filed the Ozempic and Rybelsus CV risk reduction indications as a means to mitigate the regulatory risk. Below, FENIX provides thoughts on the new Ozempic indication, insight into why the lack of a Rybelsus CV indication may not really matter in the long run, and readthrough to Lilly (REWIND) and Intarcia (ITCA-650).

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Novo 2019 Capital Markets Day Highlights and Analysis

Novo hosted its 2019 Capital Markets Day and provided updates on the strategic direction of the company through 2025 including commercial activities and R&D strategy. Of note, Novo provided clarity on Rybelsus positioning vs. Ozempic and competitor products as well as details on novel drug delivery technologies, including two oral peptide delivery methods being developed at MIT and the semaglutide+AM833 injection device. Below, FENIX provides details and insights from the call.

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