Results

Novartis wins big in head-to-head Eylea matchup, setting up a looming market feud with Regeneron

Novartis investigators went head-to-head with Regeneron’s blockbuster Eylea in two large Phase III studies. And they scored, scooping up promising top-line results and setting up a 2018 filing that puts them on a collision course with the big biotech.

The pharma giant announced this morning that it had hit the primary — non-inferiority to Eylea — and secondary endpoints with RTH258 among 1,800 patients with neovascular age-related macular degeneration (nAMD) across 400 centers worldwide.

The key for this drug, though, wasn’t non-inferiority to a drug that earned $3.3 billion last year. Novartis’ 6 mg therapy, frequently cited as one of its top late-stage drug prospects, worked on a once-every-12-weeks schedule for 57% and 52% of the patients in the two trials.

Regeneron’s shares $REGN slid 2.5% in premarket trading. Novartis’ shares jumped 1.5%.

Those figures represent a clear victory for Novartis, as analysts had stepped back to see just how big a concentration of patients could achieve equal visual acuity on a 12-week schedule compared to Eylea’s 8-week regimen.Novartis itself had said it needed to get at least 40% of the patients on the 12-week dosing schedule for this to be a blockbuster opportunity.

Two months ago, Leerink’s Geoffrey Porges noted:

Since Eylea is the control arm, and is being given on the standard q8 week schedule, there will be the appearance of superior convenience for some patients, but the perceived advantage for RTH258 will depend on what proportion of patients are actually managed on the less frequent dosing schedule. If that proportion is relatively small (15% or less), then we expect the commercial advantage for RTH258 to be modest. If the proportion of patients controlled on the longer schedule is large (40-50% or higher), then we expect the commercial advantage, and impact, to be significant.

Leerink’s Seamus Fernandez followed up with the score today: “Based on these results, we expect RTH258 to be a major competitor in the US to Eylea and Lucentis, and essentially replace Lucentis overseas where NVS controls marketing.”

That’s not what Regeneron wants to hear right now. While the biotech has racked up back-to-back approvals for Dupixent and sarilumab, it’s also been struggling on the PCSK9 front, alongside its partner Sanofi. Eylea has been a mainstay for the company for years now, funding its rapid growth for the past 6 years. Any market loss to Novartis, which says it should be ready to file its applications next year, would be painful.

Competition from Lucentis has already slowed growth of the franchise.

“These results clearly and convincingly demonstrate RTH258 has the potential to reduce injection burden while providing excellent visual outcomes.  Given our legacy in developing medicines to preserve vision, we are pleased that RTH258 carries the promise of being the next major advancement for patients with nAMD” said Vas Narasimhan, global head, drug development and chief medical officer, Novartis. “Based on these robust data, we are looking forward to working with regulatory agencies to bring this pioneering treatment to patients.”


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RAPS Regulatory Convergence 2017