Just a few weeks after Novartis $NVS spelled out exactly why it believes RTH258 can carve out a blockbuster chunk of Regeneron’s AMD market for Eylea, its big rival says that a next-gen combo won’t be riding to their rescue.
Early Monday Regeneron $REGN said both Phase II studies of nesvacumab — an angiopoietin2 (Ang2) antibody — in combination with Eylea failed to beat a solo version of their flagship therapy. And that’s forcing both Regeneron and its allies at Bayer — which paid $50 million upfront to partner here — to drop Phase III plans.
The combination “did not provide sufficient differentiation to warrant Phase III development,” Regeneron noted in a short statement. The data will have to wait for an upcoming scientific conference.
Regeneron shares dropped 2.5% in pre-market trading on Monday.
The latest setback at Regeneron for their ophthalmology group comes a little more than a year after its anti-PDGF antibody rinucumab combined with its blockbuster drug failed a Phase II for age-related macular degeneration. There was a slight improvement in vision, but it wasn’t enough to make a commercial difference for Regeneron.
Earlier this month, Novartis development chief Vas Narasimhan spelled out a key success for RTH258 from their ambitious late-stage development effort. At week 16 the two RTH258 arms had 33% and 35% fewer patients with damaging retinal fluid, and at 48 weeks one arm had 41% fewer patients in the danger zone, compared to the competitor. Active disease was observed in 23.5% of brolucizumab 6 mg patients versus 33.5% of aflibercept patients in HAWK, and in 21.9% of brolucizumab patients versus 31.4% of aflibercept patients in HARRIER. And there’s a lot at stake, with Regeneron taking in $953 million in US Eylea sales in Q3.
Novartis is betting that moving patients from once every 8 weeks for Regeneron’s flagship therapy to a 12-week regimen will win over a big slice of the market. Regeneron, meanwhile, is left with their own program to demonstrate success with a quarterly injection of Eylea.
Back-to-back setbacks like this are unusual for Regeneron, which has enjoyed a series of development successes. CSO and co-founder George Yancopoulos, though, says it’s hard to improve on a drug like Eylea, adding that the company is still hard at it in ophthalmology.
We expect to report results in the first half of 2018 from our EYLEA Phase III study in diabetic retinopathy, which represents a growing patient population with significant need. We also continue to invest in additional R&D approaches in ophthalmology with the goal of providing new innovations to patients with serious vision-threatening diseases.
Image: Regeneron R&D Chief George Yancopoulos Getty
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