Tag Archives: Novo Nordisk

Ph3 Icosema Trial Observed; Novel T1DM Treatment Development; DIAGNODE-3 Trial Observed

Three cardiometabolic-related news items have recently been observed: Novo Nordisk initiated the first Ph3 icosema trial (COMBINE 3) evaluating icosema (QW insulin icodec + semaglutide) vs. basal-bolus in T2DM patients; Adhera Therapeutics announced an agreement with Melior Pharma for Adhera to license MLR-1023 (tolimidone) for the development of a novel T1DM therapeutic option; and Diamyd initiated a Ph3 trial (DIAGNODE-3) evaluating the Diamyd diabetes vaccine in recently diagnosed T1DM patients carrying the HLA DR3-DQ2 haplotype. Below, FENIX provides highlights and insights for the respective news items.

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Wegovy Launch Impresses; Guidance Raised; Novo Q2 ’21 Earnings Update

Novo Nordisk hosted its Q2 ’21 earnings call and provided updates across its commercial and pipeline activities, including the ongoing Wegovy and Rybelsus launches and Novo’s intentions to develop and launch an ASCVD or HF product between 2024 and 2028. Of note, the earnings call was previously scheduled for tomorrow (August 5, 2021), but the company curiously moved it up by a day. Below, FENIX provides highlights and insights from the call.

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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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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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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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Novo Partners for HF Cell Therapy

Novo Nordisk and Heartseed announced a global partnership and license agreement for the development, manufacturing, and commercialization of Heartseed’s lead asset HS-001. For context, Heartseed’s lead candidate, called HS-001, is an investigational cell therapy for the treatment of heart failure that uses purified cardiomyocytes derived from induced pluripotent stem cells (iPSC). Below, FENIX provides highlights and insights from the press release.

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Novo Resubmits 2.0mg High-dose Ozempic to FDA

Novo Nordisk announced it has resubmitted the sNDA to FDA for QW high-dose 2.0mg injectable semaglutide for the treatment of T2DM. Recall, in March 2021, Novo announced it received a Refusal to File letter from FDA (previous FENIX insight) after initially filing the application on January 20, 2021 (previous FENIX insight). Below, FENIX provides thoughts on the refiling.

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Lilly Obesity Ph2 GGG Tri-agonist Trial; Novo QW Icodec Ph3 T2DM; Sigilon Q1 ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: a CT.gov record for a Ph2 Lilly-sponsored trial investigating QW LY3437943 (GGG tri-agonist) in obesity has been observed; a CT.gov record for Novo Nordisk’s Ph3 QW insulin icodec T2DM trial (ONWARDS 4) has been observed; and Sigilon announced its Q1 ’21 earnings, though it did not provide a development update on SIG-002 nor did it host an associated webcast. Below, FENIX provides highlights and insights for the respective news items.

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Bigfoot Unity Receives 510(k) Clearance; Bayer’s FIGARO-DKD Meets Primary Endpoint; Viatris Q1 ’21 Earnings Update; Novo Insulin Product Samples Recalled

A series of cardiometabolic-related news items have been observed: Bigfoot announced FDA granted 510(k) clearance for its Bigfoot Unity Diabetes Management System which features connected smart pen caps integrated with Abbott’s Libre 2 CGM; Bayer announced the Ph3 FIGARO-DKD CVOT evaluating finerenone in ~7,400 adults with CKD and T2DM has met its primary endpoint; Viatris hosted its Q1 ’21 earnings call; and Novo Nordisk announced a voluntary recall of 1,468 Levemir, Tresiba, Fiasp, Novolog, and Xultophy product samples due to improper storage temperature conditions. Below, FENIX provides highlights and insights for the respective news items.

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