Today, Novo Nordisk announced an exclusive partnership with Staten Biotechnology for the development of novel treatments for hypertriglyceridemia. Of note, this is Novo’s first partnership focused on hypertriglyceridemia. Below, FENIX provides additional thoughts on this partnership in relation to Novo’s strategic priorities and R&D partnerships.
The ACC published their 2018 ACC Expert Consensus Decision Pathway on Novel Therapies for CV Risk Reduction in Patients with T2DM and ASCVD in JACC. Notably, the ACC recommends SGLT2i use for potential CV benefits and GLP-1RA use for those patients who may have an unsuitable risk profile for SGLT2i use. Below, FENIX provides a winners-and-losers analysis based on the recent ACC recommendations compared to the updated ADA/EASD guidelines from October 2018.
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.
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).
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.
Today at the 2018 ISPAD congress, Novo Nordisk presented data from Onset 7, the first study evaluating Fiasp (faster-acting insulin aspart) in pediatric/adolescent patients. Below, FENIX provides thoughts on the ultra-rapid-acting (uRAI) market, the use of these agents in pediatric T1DM patients, and Onset 7 in the context of Fiasp’s post-approval pediatric commitment.
Merck has reportedly asked Samsung Bioepis to cancel their development and commercialization deal for biosimilar glargine. The report comes from a filing with the Korean stock exchange. While it remains unknown, this news may signal Merck’s intention to abandon the global commercialization of its bs-glargine. According to the filing, Merck has offered to pay $155M to Samsung to end the contract. Below, FENIX provides thoughts on potential reasons to cancel the deal as well as read-through to the other basal insulin manufacturers.
ADA and EASD have updated their T2DM consensus guidelines (journal publication) with notable changes to the framework of the treatment algorithm (pictured below). Now, the algorithm takes a patient-centric approach and suggests a stepwise methodology based on the highest priority for the patient (ASCVD, CKD, hypoglycemia minimization, weight loss, and cost). Importantly, the guidelines recommend the use of GLP-1RA over insulin as the first injectable therapy as well as other in-class H2H drug recommendations. Below, FENIX provides a winners-and-losers analysis, highlights of the guideline updates, and how the identified knowledge gaps may be addressed.
Lilly presented results from a Ph2b study evaluating its GIP/GLP-1 dual-agonist (LY3298176) vs. 1.5mg Trulicity, both dosed QW. The results were also published in The Lancet. The trial demonstrated at 26 weeks up to -2.4% reductions in A1C and -11.3 kg weight loss on the highest dose of the LY dual-agonist. Of note, Lilly disclosed plans to initiate Ph3 for LY3298176 “no later than early 2019” with trial completion in 2021. The T2DM Ph3 program will be called “SURPASS,” which seems like it could be a subtle dig at Novo’s injectable semaglutide Ph3 program called SUSTAIN, since Lilly will attempt to surpass semaglutide with its dual-agonist. Additionally, Lilly said it is planning to evaluate the GIP/GLP-1RA in obesity and “…other conditions” (likely NASH). Below, FENIX provides an overview of the LY Ph2b results and their potential impact to Novo Nordisk and Sanofi.
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.