Tag Archives: Diabetes

JNJ Q4 ’18 Earnings Update

JNJ hosted its Q4 ’18 earnings call (press release) and briefly discussed financial results for its Invokana franchise. Of note, the recent Invokana CV indication listed on a single slide, but was not discussed during prepared remarks or Q&A (see previous FENIX insight). Below, FENIX provides financial highlights for Invokana and perspective on the ongoing CV indication launch.

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CGM: Novel Non-invasive Platform Similar To Libre CGM Data

Today, Know Labs, a diagnostic solutions company evaluating the use of its Bio-RFID platform with non-invasive UBANDTM wearable (Fitbit like device) announced laboratory comparison test results of UBAND vs. Abbott FreeStyle Libre. Of note, the results demonstrated ~90% correlation to the Libre CGM data. The company previously announced the laboratory comparison test results of UBAND vs. Dexcom G5. Below, FENIX provides thoughts on non-invasive option for CGM.

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Tresiba U-100 10mL vial FDA approved

According to Drugs@FDA, Novo Nordisk has received US approval for the commercialization of a 10mL vial of Tresiba U-100. Of note, Novo has not received approval for a U-200 vial. Below FENIX provides additional details on the new vial, specifically as it pertains to pediatric use.

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Thoughts on PIONEER-6 Results

On Friday, Novo Nordisk announced positive top-line results from the oral semaglutide CVOT, PIONEER-6. Although PIONEER-6 did not meet superiority for 3P-MACE, Novo reported statistically significant (ss) ~50% RRRs for CV death and all-cause mortality. Below, FENIX discusses the likelihood for the semaglutide franchise to receive a CV risk reduction indication in the context of the somewhat divergent PIONEER-6 results, a description of different filing scenarios against Lilly characterized as high likelihood, low likelihood, and “power move”, what an FDA adcom could look like, and finally, external factors of influence. PIONEER-6 consistency check Below is a table comparing the results……

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Dexcom G6 Medicare Availability in Early 2019; New Data Partnership with Validic

Dexcom announced the G6 CGM will be available to Medicare patients starting early 2019. Additionally, Dexcom has entered into an agreement with Validic to integrate Dexcom CGM data into Validic’s data connectivity platform, called Validic Inform, which streams data from in-home connected devices into HCP systems. Below, FENIX provides thoughts on G6 Medicare availability as well as reasons why the Validic partnership makes sense for Dexcom.

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New Ozempic “Real-World Pragmatic Study” with Anthem

Novo Nordisk and Anthem’s outcomes research subsidiary, HealthCore, announced they are working together on a “real-world pragmatic study” (called SEPRA as in SEmaglutide PRAgmatic) evaluating Ozempic vs. standard of care (defined as commercially available oral or injectable antidiabetic medication other than semaglutide). The study initiated in July 2018 and is currently recruiting patients. Below, FENIX provides insight into potential motivating factors for Novo conducting the study (e.g. pilot for an outcomes-based contract).

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Abbott and Roche Q3 ’18 Earnings Updates

Abbott and Roche held their Q3 ’18 earnings calls and provided updates on their diabetes businesses. Of note, Abbott disclosed it has reached >1M global Libre users, which is ahead of their YE ’18 goal. No updates were provided on US launch timings for Abbott Libre 2 or Roche Solomicro pump. Below are highlights from the respective events.

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MannKind Receives Warning for Afrezza Facebook Promo

FDA’s Office of Prescription Drug Promotion (OPDP) issued a letter to MannKind claiming misleading/false advertising for Afrezza Facebook posts. According to the letter, on February 9 and March 19, 2018, MannKind posted advertisements on Facebook that made “false or misleading claims and/or representations about the risks associated with Afrezza by suggesting that there are no safety concerns associated with the use of the drug.” The Facebook posts have since been deleted. Below, FENIX provides thoughts on the warning letter including any potential impact to the Afrezza brand.

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J&J Q3 ’18 Earnings Update

J&J hosted its Q3 ’18 earnings call but only briefly discussed the Invokana franchise. Senior management did not comment on the CANVAS/R review which is anticipated this month. Recall, in July 2018, J&J announced FDA extended the CANVAS/R sNDA review by 3 months. Below, FENIX provides thoughts on the CANVAS review as well as potential read-through from Lilly’s Ph2b dual agonist results to J&J’s dual agonist, JNJ-64565111.

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AZ’s Head of CVRM Joins Novo

Novo Nordisk announced Ludovic Helfgott (pictured below), current global head of AZ’s CV, renal, and metabolism (CVRM), is joining Novo as the Executive VP of Biopharm. According to the press release, Helfgott will join Novo effective April 3, 2019 at which point Jesper Brandgaard, current head of Novo Biopharm and well-known former CFO, will retire. Below, FENIX provides thoughts on Helfgott’s appointment and potential future impact to Novo as well as an analysis of how the Biopharm position could help Helfgott’s career.

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