Category Archives: Topics

CORRECTING AND REPLACING: Empa T1DM 2.5mg Safe; 1 Death at High Dose; Paul Strumph no longer with Lexicon

Today at the EASD 2018 conference, BI/Lilly presented data from the Ph3 EASE-2 and EASE-3 empagliflozin T1DM studies along with simultaneous publication in Diabetes Care. Results demonstrated slightly greater reductions in A1C compared to the sotagliflozin and dapagliflozin Ph3 studies; however, there was one death from DKA in a patient on 25mg empagliflozin. Details about the death are described in the EASE Ph3 publication supplementary appendix. Below, FENIX provides a curious press release observation, a winners & losers analysis, and a comparative DKA SGLTi analysis and overview of the EASE-2 and EASE-3 results.

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New Intarcia CMO Fred Fiedorek

Intarcia has a new CMO according to their completely redesigned website. Fred Fiedorek has seemingly replaced Michelle Baron, and this is a big deal. Fiedorak assumes the role of Chief Medical Officer and Global Head of Regulatory Affairs at Intarcia, where he leaves Rhythm Pharmaceuticals in Boston after working on relamorelin and setmelanotide.

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Positive LLY URLi Ph3 Topline Results

Lilly announced positive topline results from two Ph3 studies (PRONTO-T1D and PRONTO-T2D) for its ultra rapid-acting insulin lispro (URLi). According to the press release, URLi demonstrated non-inferiority in A1C to Humalog along with significant improvements in PPG. Below, FENIX provides thoughts on URLi implications to the overall ultra rapid-acting insulin market.

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HARMONY Superior; REWIND and PIONEER-6 Expectations High

Full results from the albiglutide CVOT, HARMONY Outcomes, have been published in the Lancet and were presented at EASD 2018. As somewhat of a surprise, results demonstrated a 22% RRR in the 3P-MACE primary endpoint (p=0.0006). In a press release, GSK announced the results and disclosed they are “exploring opportunities to divest this medicine to a company with the right expertise and resources to realise its full potential for patients.” Recall, FENIX recently presented a scenario highlighting a strong possibility that HARMONY could show superiority including GSK likely divesting albiglutide for its re-commercialization. Below, FENIX provides perspective on the potential market implications in a winners & losers analysis, as well as who albiglutide suitors are unlikely to be.

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Libre 2 With Real-Time Alerts/Alarms Approved in EU

Abbott announced it received CE Mark for the FreeStyle Libre 2, which now includes optional real-time alerts/alarms. Abbott said it will price Libre 2 at parity to the original Libre System and the company is planning an EU launch in the coming weeks. Abbott did not disclose its regulatory/commercial plans for the US; however, this remains a large market opportunity for the company and is anticipated in the coming months. Importantly, during Abbott’s EASD symposium, it was shown that the Libre 2 CE Mark approval includes the updated algorithm for overall 14-day accuracy at 9.5% MARD (US is 9.4%). Below, FENIX provides the key highlights and potential implications to the CGM market.

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New Novo Stem Cell Manufacturing Facility

Novo Nordisk announced plans to establish a stem cell manufacturing facility in Freemont, California. The GMP-certified facility was previously operated by Asteria Biotherapeutics and Novo has signed an agreement with the company. According to the press release, the plant will be operational in 2019 at which time, it will be used to support Novo’s clinical development programs. Below, FENIX provides thoughts on Novo’s stem cell program.

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UPDATED: Novo to Launch Connected Pens and New Connected Care Partnerships with Dexcom, Roche, and Glooko

UPDATED: Both Novo connected pens utilize NFC to transmit data. Previously, it was thought that the pens would use Bluetooth since Dexcom and Roche also use Bluetooth.

With the start of the 2018 EASD conference, Novo Nordisk announced upcoming plans to launch two connected reusable pens (NovoPen 6 and NovoPen Echo) in addition to digital health partnerships with Dexcom, Roche, and Glooko. According to the press release, Novo plans to initiate the launch of its connected pens in Q1 2019. Importantly, Novo also disclosed intentions to launch connected disposable pens “later in 2019.” Below, FENIX provides thoughts on Novo’s connected pens and new partnerships.

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New H2H Tresiba vs. “Lantus” CGM Crossover Study (SWITCH PRO)

A CT.gov record for a new Ph4 T2DM basal-only crossover study (SWITCH PRO) comparing Tresiba (U100) to “Lantus” has been observed. The study was likely named SWITCH PRO because of the crossover design and the use of Abbott’s Libre Pro blinded CGM. Below, FENIX provides thoughts on how Novo could leverage the study to augment its results from the previous SWITCH 1 and SWITCH 2 studies as well as context for the use of time-in-range as the primary endpoint to be first such trial included in the Tresiba label.

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UPDATED: Lilly Oral GLP-1RA with Chugai

UPDATED: FENIX has included abstract text and the associated poster (download PDF here) that was presented at ADA 2018

Lilly announced it has in-licensed the global development and commercialization rights to Chugai’s non-peptidic GLP-1RA, which is ready to enter Ph1. Below, FENIX provides more details and insight on the deal, especially in the context of Novo’s oral semaglutide. According to the press release, Chugai will receive $50M in an upfront payment and is eligible for undisclosed milestone payments as well as royalties if OWL833 is commercialized.

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Novo To Layoff 250 US Workers

Novo Nordisk is reportedly cutting 250 US-based jobs. The most recent round of layoffs appears to be part of the June 7 report that Novo was considering cutting 3000 jobs. Recall, on September 18, the company also announced plans to restructure its global R&D organization which included cutting 400 R&D jobs. Below, FENIX provides known details of the US job cuts and an updated headwinds/tailwinds analysis for the ongoing Novo personnel reductions.

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