New data for Bayer, Regeneron drug Eylea may help it gain ground from Lucentis

Bayer's eye drug Eylea has already enjoyed a wealth of success since its approval, and now it looks to be in for much more. The company has announced positive late-stage study data that could put the drug in a new market sooner than expected, a development that would help it continue to give Roche's ($RHHBY) Lucentis a run for its money.

Tuesday, Bayer said two late-stage tests for Eylea against diabetic macular edema (DME) met their primary goals of improving vision compared with laser surgery. The outcome means that codeveloper Regeneron ($REGN), which markets the drug in the U.S., can now submit an application for U.S. marketing approval for that indication later this year--about a year earlier than planned. Bayer will seek the same approval in the EU. According to Bayer, the treatable population for DME worldwide is an estimated 6.2 million people. "DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes. We look forward to being able to offer medical benefit to patients with this new treatment option for DME," said Kemal Malik, Bayer's head of global development, in a statement.

Eylea has been steamrolling since it was first approved in the U.S. in November 2011 for the treatment of wet age-related macular degeneration. The sight-saving drug hauled in $124 million for Regeneron in its first full quarter on the market, and a new indication in late 2012 for macular edema following central retinal vein occlusion helped it follow up with $837.9 million in net sales last year. Those numbers toppled estimates, leading Regeneron's execs to qualify for $140 million in 2012 compensation. And most recently, Reuters says, U.S. sales rose 70% in the second quarter to $330 million, leading the company to up its 2013 sales estimate to $1.3 billion to $1.35 billion from its previous forecast of $1.25 billion to $1.33 billion--numbers that will push it further into blockbuster territory.

Bayer HealthCare, which holds marketing rights outside the U.S., has not done so badly, either. Though it is a bit behind Regeneron's schedule, after launching Eylea in the fourth quarter of last year, it reaped €14 million, or about $18 million, in 2012 sales. And it's now in line for adoption by the U.K.'s National Health Service (NHS) after receiving backing from cost-effectiveness watchdog NICE in May.

All of Eylea's sales success has come in spite of direct competition from Roche's Lucentis, which Novartis ($NVS) markets in Europe. Roche's blockbuster brings in $1.6 billion in global annual sales, according to Forbes, but sales were down 3% last year largely because of Eylea, which can be injected into the eye less often than Lucentis. Now, one edge for Roche's drug--an approved use for DME--may soon be diminishing if things for Eylea's makers go according to plan.

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