Category Archives: Topics

Sanofi’s Head of Primary Care and 3 Other Execs Set to Leave

It is being reported by Bloomberg that a series of Sanofi executives are leaving the company as “part of the broader effort to shake up Sanofi.” The four execs are said to include Dieter Weinand (EVP Primary Care), Ameet Nathwani (EVP, CMO, and Chief Digital Officer), Kathleen Tregoning (EVP External Affairs), and Dominique Carouge (EVP Business Transformation). Sanofi is anticipated to issue a press release regarding the departures later today. Below, FENIX provides brief thoughts on the continued changes in Sanofi senior leadership.

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Senseonics Integrates with Companion Medical; Nemaura Medical CY Q4 ’19 Earnings Update

Senseonics announced a new partnership with Companion Medical to integrate Eversense implantable CGM data into the Companion Medical InPen platform. Additionally, Nemaura Medical issued a press release for its FY Q3 ’19 (CY Q4 ’19) earnings. Below, FENIX provides thoughts on the partnership including why it makes sense for both Senseonics and Companion Medical.

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Zealand to Acquire Valeritas; vTv Positive Ph2 Data for TTP399 in T1DM

A series of diabetes-related news has been observed including an announcement that Zealand intends to acquire Valeritas’s assets (manufacturer of the V-Go insulin delivery device) as well as positive topline results from the vTv Therapeutics Ph2 Simplici-T1 study of TTP399, a novel glucokinase activator. Zealand and vTv hosted calls with investors to discuss their respective news items. Below, FENIX provides highlights and insights including thoughts on how vTv may have a difficult time finding a TTP399 Ph3 partner given the ongoing SGLT2i T1DM regulatory situation.

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New Novo GLP-1/GIP Ph1 Trial?

A CT.gov record has been observed for a new Novo Nordisk Ph1 trial evaluating the co-administration of subcutaneous semaglutide and a novel, unidentified compound (NNC0480-0389). Below, FENIX provides an overview of the trial as well as insights as to why NNC0480-0389 is believed to be a GIP agonist.

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Novo Q4 ’19 London Earnings; Sanofi and BD Q4 ’19 Earnings Updates

Novo Nordisk hosted its post-Q4 ’19 earnings event in London. Furthermore, Sanofi and Becton Dickinson held their respective Q4 ’19 earnings calls. Below, FENIX provides highlights and insights from the earnings calls including Sanofi’s plans to divest its interest in efpeglenatide as well as thoughts on how Novo’s QW basal insulin icodec could have broader implications to the hybrid closed-loop market.

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Tirzepatide CVOT Record Available on CT.gov

A new CT.gov record for Lilly’s tirzepatide CVOT (SURPASS CVOT) has been observed. The trial details are consistent with Lilly’s discussion during its recent Q4 ’19 earnings call. Below, FENIX provides an overview and brief thoughts on the SURPASS CVOT study.

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Merck Keeps Januvia As it Spins Off Other Legacy Brands

In conjunction with Merck’s Q4 and FY 2019 earnings call, the company announced plans to create a spin-off company with assets from Merck’s Women’s Health, Legacy Brands, and Biosimilars business. There was no mention of Merck/Pfizer’s Steglatro franchise on the call. Below, FENIX provides highlights from the Merck earnings call as well as insights as to why Januvia is not included in the spinoff company.

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Dexcom Non-intensive G6 CGM Updated Approval; Dexcom G5 Receiver Recall; FDA Concludes MET NDMA Impurity Investigation

A series of diabetes-related news has been observed including a new 510(k) clearance for Dexcom’s G6 iCGM in non-intensive diabetes management, Dexcom G5 Mobile Class 2 Device recall, and FDA finalized its investigation into potential metformin impurities. Below, FENIX provides highlights and insights for the respective news items.

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Rybelsus and URLi Receive Positive CHMP Opinions

Two important positive CHMP opinions were received this week for Novo Nordisk’s Rybelsus and Lilly’s ultra-rapid lispro product (to be branded as Liumjev). Below, FENIX provides thoughts on the positive CHMP opinions including insight into the ongoing US FDA review of Lilly’s URLi.

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