Tag Archives: Diabetes

Bigfoot Unity and Zegalogue RTU Dasiglucagon Now Available in the US; Carmot Initiates GIP/GLP Trial in Obesity and T2DM; Dexcom Launches TIR Educational Campaign; Dario Selected as Digital Health Provider for Coastal Family Health Center

Ahead of the 2021 ADA conference (June 25-29), a series of cardiometabolic-related news items have been observed: Bigfoot announced the Bigfoot Unity connected system is now available in select markets across the US; Zealand announced US commercial availability of its dasiglucagon hypoglycemia product, Zegalogue; Carmot Therapeutics announced initiation of a Ph1 trial evaluating a QW dual GLP-1/GIP RA, CT-388; Dexcom announced the launch of an awareness and educational campaign called The Global Movement for Time in Range; and Dario Health announced it was selected as a digital health provider for Coastal Family Health Center. Below, FENIX provides highlights and insights for the respective news items.

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Imeglimin Approved in Japan as “Twymeeg”; Diamyd Q1 ’21 Business Update

Two cardiometabolic-related news items have been observed: Poxel and Sumitomo Dainippon Pharma announced Japanese approval of 500mg oral imeglimin, branded as “Twymeeg,” for the treatment of T2DM; and Diamyd announced its quarterly report for Q3 ’21. Below, FENIX provides highlights and insights for the respective news items.

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Bigfoot Unity Video Highlights Connected System; Celon’s Next-gen GPR40 Enters Ph2 Development

Two diabetes-related items have been observed: Bigfoot recently highlighted its Bigfoot Unity system ahead of the impending launch; and Celon Pharma announced it filed for approval to begin a Ph2 trial investigating a second-generation oral QD GPR40 agonist, referred to as CPL’280, for the treatment of T2DM. Below, FENIX provides highlights from the respective items as well as thoughts on Celon’s decision to advance its GPR40 agonist despite the previous failed efforts from competitors (e.g. Lilly, Amgen, etc.).

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Jardiance HFrEF EC Approval; June 21-24 CHMP Agenda

Two cardiometabolic-related news items have been observed: BI/Lilly announced Jardiance received EC marketing authorization for the HFrEF indication; and the CHMP agenda for this month (June 21-24) has been released, and it includes one notable item, DAPA-CKD, as well as several other cardiometabolic-related entries. Below, FENIX provides highlights and insights from the respective items.

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Novo to Expand Basal Insulin Titration App to EU and Asia; Novo Partners for Oral Protein Delivery; Closes $100M Series F

A series of cardiometabolic news items have been observed: Novo Nordisk (in partnership with Amalgam Rx) plans to expand the availability of the Dose Check basal insulin titration app in Europe and Asia (press release); Novo partners with Lumen Bioscience for oral protein manufacturing and delivery (press release); Fractyl announced the closing of a $100M Series F (press release). Below, FENIX provides highlights and insights for the respective news items.

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One Drop hires former Sanofi Head of Innovation and Diabetes portfolio

One Drop announced the hiring of Sanofi’s former Head of Innovation and Diabetes Portfolio, Carrie Siragusa, as One Drop’s new VP of commercial strategy (view LinkedIn; pictured below). According to the press release, Siragusa will be part of the team tasked with commercializing a “multi-analyte dermal sensor with continuous health sensing capabilities.” Below, FENIX provides thoughts on Siragusa’s hiring in the context of One Drop’s goal to move beyond BGM as well as insight into the potential impact on the overall CGM market.

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Wegovy Added to Evernorth Obesity Program; STEP HFpEF DM Trial Observed; JDRF Issues RFA for CGM+Continuous Ketone Monitoring; One Drop Surpasses 25B Data Points

A series of cardiometabolic news items have been observed: Evernorth announced the expansion of its Weight Management Care Value program to include Novo Nordisk’s Wegovy (2.4mg semaglutide); a new Novo-sponsored trial, referred to as STEP HFpEF DM, has been observed evaluating semaglutide in people living with HF, obesity, and T2DM; JDRF issued an RFA for the development of combination CGM + continuous ketone monitoring (CKM) devices for the use of preventing DKA in patients with T1DM; and One Drop announced it has surpassed 25B longitudinal biometric data points in its platform. Below, FENIX provides highlights and insights for the respective news items.

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ViaCyte Closes $45M Series D Tranche; Oramed Randomizes 50% of Patients in Oral Insulin Trial; Dario Completes wayForward Acquistion

A series of cardiometabolic news items have been observed: ViaCyte announced it has closed a $45M financing deal bringing the company’s Series D funding total to >$115M; Oramed announced it has enrolled and randomized 50% of the 675 T2DM patients in its Ph3 trial (ORA-D-013-1) evaluating its oral insulin; and Dario announced the closing of its acquisition of wayFoward. Below, FENIX provides highlights and insights for the respective news items.

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Wegovy WAC Pricing Analysis

As a follow up to FENIX’s Wegovy label analysis from yesterday, FENIX provides additional thoughts on the Wegovy WAC pricing vs. Saxenda. According to Novo Nordisk’s pricing websites, both Wegovy and Saxenda are being offered at the same WAC of $1,349.02. However, since a 4-pen pack of Wegovy is for 28 days and a five-pen pack of Saxenda is for 30 days, the daily cost of Wegovy is slightly higher than that of Saxenda (see table below). Below, FENIX provides insight on why Novo would offer a premium product near pricing parity with its predecessor.

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Wegovy Label Analysis; Novo Investor Event Highlights

Today, Novo Nordisk hosted an investor call following its announcement late Friday (June 4) that FDA approved 2.4mg semaglutide, branded as “Wegovy,” for the treatment of obesity. The approval was based on results from the STEP Ph3a clinical trial program which demonstrated 17% weight loss after 104 weeks with 40% of patients losing ≥20 of their body weight after 104 weeks. Importantly, Novo intends to quickly launch Wegovy starting on June 10, 2021. Below, FENIX provides a Wegovy label analysis including thoughts on Novo’s decision to launch the product in five single-use autoinjector pens.

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