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小编语:因日前EU批准拜耳的Eylea的在新适应症糖尿病引起的黄斑湿性病变上使用,诺华的Lucentis将遭受很大的打击。
雷珠单抗适用于黄斑性病变,价格昂贵,所以很多地方分装阿瓦斯汀Avastin进行代替使用。现在Eylea的新适应症批准,无疑再次挤占了雷珠单抗的市场,形成了该市场的两大巨头的对抗,且势均力敌。
以下是外媒的报道(其实就是Regeneron自己的发言稿,拜耳的合作伙伴,Eylea的发明者和专利权所有人):
New use for Bayer's Eylea in EU gives it more market power against Novartis' Lucentis
August 11, 2014 | By Arlene Weintraub
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 |
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