New use for Bayer's Eylea in EU gives it more market power against Novartis' Lucentis

Last week, Regeneron ($REGN) announced that sales of its macular degeneration treatment Eylea jumped 26% to $415 million in the second quarter, blowing past analysts' estimates of $410 million. Now, its partner Bayer has more good news: The European Commission has approved Eylea (aflibercept) for the treatment of diabetic macular edema (DME), the most common cause of vision loss among people with diabetes.

The approvals just keep piling up for Eylea, which works by blocking the growth of harmful blood vessels in the eye. The drug was approved in the U.S. to treat macular degeneration in 2011. The following year, the FDA gave the green light for it to be used in macular edema following central retinal vein occlusion (CRVO). And just last month, Regeneron won FDA approval for Eylea in DME. The company is awaiting further approvals for the diabetes indication in Japan, Asia Pacific and Latin America, according to a press release.

"DME is the leading cause of vision loss in working-age adults in much of the developed world, and we believe Eylea will be an important new treatment option for these patients," said Dr. George Yancopoulos, chief scientific officer of Regeneron, in the statement.

Eylea continues to exceed expectations, despite some challenges. Last quarter, a drop in U.S. distributor inventory caused sales expansion to stall at 14%, causing some analysts to express concerns about some weakness spilling over into subsequent quarters. But those worries dissipated when Regeneron reported that Eylea helped drive second-quarter earnings of $93 million on 45% revenue growth to $666 million.

The additional indications are also helping the Bayer-Regeneron team compete against its top rival in the eye-disease market, Roche's ($RHHBY) Genentech unit and its drug Lucentis, which Novartis ($NVS) markets outside the U.S. Novartis hauled in $2.38 billion last year from Lucentis. But Eylea has one big selling point, which is that it can be injected in the eye less often than Lucentis. That benefit has helped it gain ground quickly on its rival. Regeneron estimates that Eylea will bring in at least $1.7 billion in sales in the U.S. alone this year.

And Roche has its own issues in Europe with Lucentis, where France is officially urging doctors to use its Avastin off-label to treat age-related macular degeneration instead of Lucentis. It hopes the move will save its healthcare budget at least €200 million ($273 million) a year. On top of that, Roche and marketing partner Novartis face allegations in Europe that they colluded to protect sales of Lucentis from just that kind of off-label use. Italian antitrust regulators are seeking €1.2 billion ($1.6 billion) in damages from the companies, and France and the EU have embarked on investigations of their own.

- here's Regeneron's release

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