Roche’s Vabysmo Grabs Top Growth Spot As Sales Decline
Retreats From MAGE-A4 Bispecifics
Executive Summary
The Swiss major’s Q1 earnings show significant growth for Vabysmo, which poses a threat to competitor anti-VEGF drugs from the likes of Novartis and Bayer, even as overall group sales decreased.
The strong launch of Roche Holding AG’s ophthalmological drug Vabysmo shows no signs of slowing down according to a new earnings report, even as the firm’s total sales tailed off with the end of the COVID-19 pandemic.
Roche’s Q1 group sales dipped by 3% in constant currencies to CHF15.32bn ($17.21bn) due to a significant decline in demand for its COVID-19 antigen self-test kits, although the firm stressed this was expected when considering exceptionally high demand this time last year at the peak of the Omicron wave.
The Swiss major expects the decline to continue over the course of 2023 but its guidance also outlines solid sales growth for both its pharmaceutical and diagnostic divisions. On a positive note, Q1 pharma sales increased by 9% to CHF11.7bn, driven by strong global demand for new medicines to treat severe diseases.
The biggest growth driver was Vabysmo (faricimab), which launched early last year and is indicated for neurovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). First quarter sales of the product rocketed by more than 500% to CHF432m.
“This makes Vabysmo one of the most successful launches in our history,” said Roche Group CEO Thomas Schinecker. The bispecific antibody is the first therapy to target both vascular endothelial growth factor (VEGF) and angiopoietin-2 unlike older competitors that target VEGF alone such as Novartis AG’s Lucentis (ranibizumab), which saw Q1 sales plummet by 20% to $416m. (Also see "Novartis Culls Pipeline As ‘Pure-Play’ Drive Progresses" - Scrip, 25 Apr, 2023.)
Roche unveiled post hoc analysis data on 25 April showing that Vabysmo led to greater and faster drying of retinal fluid with fewer injections when compared with Bayer AG/Regeneron Pharmaceuticals, Inc.’s anti-VEGF Eylea (aflibercept), another significant competitor.
Last year, Vabysmo showed non-inferiority versus Eylea in the visual acuity gain primary endpoint of two pivotal trials in macular edema due to branch and central vein occlusion, respectively, with label expansions anticipated. (Also see "Roche’s Vabysmo Chases Regeneron’s Eylea With New Pivotal Macular Edema Wins" - Scrip, 27 Oct, 2022.)
However, Bayer and Regeneron are working on a high-dose reformulation of their drug that could enter the market in August and help the companies win back significant market share. Furthermore, copycat versions of Eylea are in the works and set to increase pricing competition. (Also see "Roche’s Vabysmo Chases Regeneron’s Eylea With New Pivotal Macular Edema Wins" - Scrip, 27 Oct, 2022.).
Besides Vabysmo, another key growth driver for the Swiss major was its spinal muscular atrophy treatment Evrysdi (risdiplam), first quarter sales of which rose by 62% to CHF363m. More than 8,500 people to date have been treated with the therapy, which is approved in more than 90 countries.
Evrysdi’s success is likely to continue given long-term data released last month from the pivotal SUNFISH trial, which showed that improvements in motor function were maintained through the fourth year of treatment.
“Looking ahead we have one of the youngest portfolios in the industry,” Schinecker said on an earnings call. “Since 2019, we’ve launched 19 new medicines and in total we have 83 new potential medicines and about 150 projects in our pharma pipeline. This year, we are aiming for the approval of three new medicines.”
Duchenne Drug Candidate Faces New Controversy
The first of these – Columvi (glofitamab) – is a CD20xCD3 T-cell-engaging bispecific antibody that received Canadian approval for the treatment of relapsed or refractory diffuse large B-cell lymphoma last month and Roche will continue with regulatory activities in other markets.
Two other contenders with approvals anticipated in 2023 are Sarepta Therapeutics, Inc.-partnered Duchenne muscular dystrophy candidate, SRP-9001, and paroxysmal nocturnal haemoglobinuria asset, crovalimab.
However, the fate of the former is uncertain after the US Food and Drug Administration delayed an approval decision in favour of an advisory committee meeting, after it transpired that SRP-9001 was filed against the wishes of the agency’s reviewers in the first place. (Also see "10 Approvals To Look Out For In Q2" - Scrip, 20 Apr, 2023.)
Slips Away From Immunocore Collaboration
Notably, the Swiss firm’s earnings presentation revealed it had removed three Phase I trials from its development pipeline, including two for an Immunocore, Ltd.-partnered bispecific T-cell engager targeting MAGE-A4. The firm had paid $100m in upfront and near-term milestone to the partner back in 2018 for access to the candidate, but Immunocore stopped funding the program in February.