Eylea - Regeneron and Bayer HealthCare

Eylea (aflibercept)
Regeneron Pharmaceuticals and Bayer HealthCare
Launch Date: November 2011 (U.S., Regeneron); November 2012 (EU, Bayer)
First-Year Sales: $838 million (2012, Regeneron); €14 million (partial 2012, Bayer)
First-Half 2013 Sales: $643.7 million (Regeneron); €122 million (Bayer)
Analyst Estimate for 2018: $4.7 billion

Eylea had a couple of big things going for it when it arrived on the scene in November 2011. First, it required fewer eye injections than Roche's ($RHHBY) Lucentis, the only competitor approved to treat wet age-related macular degeneration (AMD). After three initial doses once every four weeks, the dosing schedule switched to just one injection every 8 weeks, compared with Lucentis' once-monthly injections. 

Second, it cost less than the Roche drug. Regeneron ($REGN) priced Eylea at $1,850 per dose, compared with $2,000 for Lucentis. While the per-injection difference wasn't all that much, savings built up over a full year's treatment thanks to Eylea's less-frequent dosing schedule, with Eylea totaling $16,000--$8,000 less than the $24,000 for Lucentis.

Eylea vs. Lucentis wasn't the battle many had their eyes on, however. Eylea's big competition at launch time was another Roche product: the cancer drug Avastin, which doctors prescribed off-label in small doses to treat AMD at a fraction of Lucentis' price. Running about $50 per injection, Avastin controlled more than two-thirds of the AMD market, according to some estimates.

But Avastin didn't hold Eylea back. In July 2012, around 7 months after Eylea's U.S. launch, Regeneron--which markets the drug in the U.S., with Bayer handling the rest of the world--raised its sales forecast for the third time. "If we hit our new forecast, we will be one of the best launches in the history of the biotechnology industry," CEO Leonard Schleifer said at the time.

And the sight-saving drug continued to steamroll from there, bringing in big bucks for both Regeneron and Bayer. Bayer scored late-2012 approvals in the EU and Japan, and in May of this year, it followed up with backing from the National Institute for Health and Care Excellence (NICE), the U.K.'s cost-effectiveness gatekeeper. Those approvals helped 2012 sales reach about €19 million. But by the first quarter of 2013, Eylea had delivered another €49 million for Bayer, adding another €73 million by June 30 for a first-half total of €122 million, or about $165 million.

Sales growth has been even more impressive for the much smaller Regeneron. The Tarrytown, NY-based company reaped $837.9 million in net sales from Eylea in 2012, well surpassing estimates and helping its top execs qualify for $140 million in compensation for the year. It surpassed expectations yet again with $643.7 million in the first half of 2013, up nearly 103% from last year's first-half total of $317.5 million.

Eylea may soon have the opportunity to encroach on more of Lucentis' market share. In August, Bayer announced positive late-stage study data for the drug in treating diabetic macular edema, a disease that affects a treatable population of about 6.2 million. Both Bayer and Regeneron intend to seek approval for that indication. A few weeks later, Eylea won European approval in patients with macular degeneration due to central retinal vein occlusion, setting it up for another head-to-head battle with Lucentis (marketed by Novartis in Europe).

For more:
Flush with Eylea sales, Regeneron plots 300-job plant expansion
Bayer, Regeneron get EU nod for Eylea, next stop Japan
Bayer's Eylea challenges Novartis eye drug for share of new market
New data for Bayer, Regeneron drug Eylea may help it gain ground from Lucentis

-- Carly Helfand (email | Twitter)

Eylea - Regeneron and Bayer HealthCare