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New Two-Year Data Confirm Genentech’s Vabysmo Improves Vision With Fewer Treatments for People With Wet-Age-Related Macular Degeneration
Regeneron’s Eylea had sales of almost $9B last year, making it the 9th most sold drug globally. Roche (Genentech) is going to - literally - give Regeneron a run for their money with its clearly superior Vabysmo.
The main advantage Vabysmo has over Eylea is the dosing interval - for instance over 2 years of the study, patients that were on Eylea needed 15 injections whereas patients on Vabysmo only needed 10 injections in order to get a similar clinical outcome. While Eylea is administered once every 1-2 months, Vabysmo can be given once every 1-4 months.
One theory explaining why we are seeing this difference is that Vabysmo is inhibiting both the VEGF-A and angiopoietin-2 pathways while Eylea only inhibits the VEGF-A pathway.
In the AMD space and the broader ophthalmology market, dosing differences when talking about different injectables are crucial - I cannot stress this enough. Eye shots hurt like h*ll. Patients hate it with passion and will gladly switch to a drug that allows them to get less frequent injections, especially if the drug has the same efficacy profile. This is also why being physicians are big on Vabysmo because less frequent injections equals better compliance which in turns equals to significantly better clinical outcomes. From experience, compliance is one of the biggest challenges in the AMD space, so anything that will compel patients to stick to the treatment plan will be considerably appreciated by physicians.
Regeneron is in serious trouble, I expect a sizeable percentage of patients to transition from Eylea to Vabysmo in the coming months.
Roche is no stranger to ophthalmology big leagues - it developed and commercialized blockbuster drug Lucentis - so this is very probably going to be a bloodbath.
Regeneron is striking back with a higher-dose formulation of Eylea that could potentially be at par with Vabysmo in terms of dosing frequency - but approval is not expected before 2023, will that be too late for Regeneron? It remains to be seen if the higher-dose Eylea formulation will be as compelling as Vabysmo, but in any case Regeneron will likely be at a disadvantage given how fortified Vabysmo’s position in the market will be by then. One thing is sure: erosion of Eylea’s market share is imminent.
Roche is also engaging with Regeneron in the AMD battlefield with its surgical implant Susvimo. Although the implant has longer response duration when compared to Eylea, uptake hasn’t necessarily been great for now due to a number of factor, mostly lack of awareness and the fact that it requires surgery.
One potential threat to Vabysmo (and Eylea) in the AMD space though is Regenxbio’s gene therapy RGX-314 that is being a developed in partnership with AbbVie. I can tell you that AbbVie is damn serious about playing in the AMD market and generally views the ophthalmology space as a very attractive and strategic growth area, so this has to potential to become very problematic for both Roche and Regeneron if the safety profile and pricing of the RGX-314 are on point.
The grand opening of Regenxbio’s new shiny manufacturing facility last month - partially thanks to AbbVie’s biobucks - is a testament to the biotech’s manufacturing capabilities. Let’s just hope they don’t sue the FDA again.
Nestlé Health Science to Collaborate with Enterome on New Therapies for Food Allergies and Inflammatory Bowel Disease
This is a very interesting deal that makes complete sense for both parties.
Enterome is no stranger to deals with big players - it is currently developing an anti-inflammatory asset for Crohn’s in partnership with Takeda and has a history of inking deals with the likes of BMS.
Nestle has been shopping around a lot lately for assets in the food allergy and gut health space, and Enterome’s EndoMimics peptide platform is very promising. The idea in a nutshell is to produce peptides that would act like cytokines to treat immune diseases. In the case of EB1010, the primary targeted condition is food allergy but given its mechanism of action, the asset can obviously be useful in the context of inflammatory bowel conditions.
Clinical trials for EB1010 are due to start in 2023, so this is an early stage program that is risky to an extent.
The deal also encompasses another Enterome’s platform - AllerMimics - that also has the potential to treat food allergies through a different mechanism - by creating immune tolerance.
Nestle is hoping to be able to combine EB1010 with assets from the AllerMimics platform. The oral combo would have a dual mode of action and will be close to impossible to compete with in the food allergy space if approved - not that Nestle has any serious competition in this space.
I am a big of fan of Nestle’s current GIT-focused strategy and I think that their latest moves, from the Seres therapeutics deal, to the acquisition of Aimmune Therapeutics two years ago, to the Enterome deal, are taking the company in a potentially very lucrative direction.
Seres is expected to complete its BLA submission for its microbiome asset SER-109 for the treatment of C. diff by mid-2022. If approved, it could be the first or the second (in the event that Ferring’s asset gets approved first) microbiome drug to hit the market in history. This has the potential to truly cement Nestle’s position in the microbiome space.
I would love to see Nestle leverage its recent experience, capabilities and alliances in the realm of the microbiome to go fishing in the autism space. Studies are showing relatively promising links between autism and the microbiome - so there could be something big here.
An interesting recent development in the autism space is Axial Therapeutics’ AB-2004 just clearing Phase 1b/2a. The asset is a first-in-class compound that targets the microbiome gut-brain axis by preventing some gut-derived metabolites from entering the bloodstream and thus reaching the brain in order to reduce irritability and anxiety due to autism.
But I think Nestle’s management is still traumatized from the whole Galderma and Nestle Skin Health debacle and are unlikely to significantly play anywhere outside the GIT space for the foreseeable future in terms of therapeutics.
ABOUT ME: Clinician turned business strategist and management consultant.
DISCLAIMER: This is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice.
DISCLOSURE: I have no business relationships with any company that is mentioned in this article.