ViewPoints: As drug launches go – this is looking special | Regeneron's Eylea

It is the drug launch that continues to surprise; when Regeneron Pharmaceuticals announced its second-quarter results on Wednesday, the company also confirmed that it had once more (for the third time) raised its full-year sales forecast for the wet age-related macular degeneration (AMD) treatment Eylea. Sales for 2012 are now expected to reach between $700 million and $750 million.

Insight, Analysis & Opinion

If Eylea does achieve this performance for the full year, it will be recognised as one of the fastest US product launches of all time, with revenues likely to be just shy of the $790 million that its chief competitor Lucentis recorded in its first four full quarters on the market following launch in mid-2006.

Market share gained by Eylea since its launch in late November has come at the expense of Lucentis and, more surprisingly, off-label Avastin usage (see Spotlight On: Lucentis versus Avastin in wet AMD), according to Regeneron management. On Thursday, Roche reported that US sales of Lucentis for the first half of 2012 were $750 million, representing a decline of 5 percent from the first six months of 2011. See ViewPoints: Roche makes counter punch in wet AMD market with US price reduction.

Furthermore, note analysts at Citigroup, the latest guidance from Regeneron appears conservative. Although analysts concede that sales growth could moderate during the second half of the year as fewer injections are given to existing patients, account penetration saturates and there become fewer patients using Lucentis or Avastin who will switch to Eylea, to hit the $700-750 million target, Regeneron will be required to deliver second-half sales of between $382 million and $432 million. The current run rate for the second half, they add, is $468 million. Will management be raising its guidance again in the third quarter?

Guidance does also not include likely approval of Eylea for the treatment of central retinal vein occlusion in September (see ViewPoints: New data supports likely uptake of Eylea in CRVO setting). Indeed, additional indications – the other notable one being diabetic macular degeneration (DME) – are expected to be key battle grounds for Lucentis and Eylea over the next few years. Furthermore, an FDA advisory panel recommended on Thursday that Lucentis should be recommended for approval in this indication, even at higher doses.

A key advantage of Eylea is its less frequent dosing. Andrew Berens – an analyst at Bloomberg – suggested to FirstWord that higher dosing for Lucentis could in theory help to offset the superior binding affinity/dosing frequency advantage of Eylea. Irrespective of Lucentis' progression in DME, one suspects that Regeneron management are happy with the performance of their product.

See also: ViewPoints: Has Fovista data put Opththotech on Roche's shopping list?

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