随着世界范围内患有痛风群体比例的不断上升，痛风药物市场已经成为各大医药公司想要竞逐的地方。而阿斯利康凭借着其正处于三期临床研究的药物lesinurad有可能在这一领域拔得头筹。根据相关媒体报道，痛风最近几年在西方国家一直呈现上升趋势。以美国为例，2011年约有830万美国人患有痛风，而2012年英国患有痛风的人数比1997年增加了64%。而目前市面上流行的一些痛风药物主要只有已经使用了50年之久的allopurinol和武田药业和Ipsen公司的febuxostat，后一种药物是在2009年被批准上市。但是这些药物并不能改善所有患者的症状。因此，市场目前急需新的治疗痛风药物的出现。

阿斯利康的lesinurad是一种URAT1受体抑制剂。在最近的三期临床研究中，这种药物相对于上述两种药物能够明显降低血液中尿酸含量，改善痛风症状。一些分析师认为这种药物一旦上市，其销售额能够突破10亿美元。而另一方面，有些研究人员对这种药物的副作用表示关注，在lesinurad的临床二期研究中，研究人员发现lesinurad可能会导致肾脏问题。

AstraZeneca may have a gout blockbuster on its hands with lesinurad

With the rates of gout on the rise throughout the world, AstraZeneca ($AZN) and its Phase III therapy lesinurad could be lined up for a lead role in a growing market, welcome news for the sluggish pharma giant and its thin late-stage pipeline.

As Bloomberg points out, the disease is on the rise in the West, afflicting 8.3 million Americans by 2011 and increasing 64% in the U.K. from 1997 to 2012, and roughly 17.7 million patients are expected to come down with gout by 2021, according to a study. Meanwhile, current treatments are limited to the 50-year-old generic allopurinol and Takedaand Ipsen's ($IPN) febuxostat, a drug approved in 2009 that doesn't work in every patient, the news service notes.

That sets the stage for AstraZeneca and its promising lesinurad. The drug is a selective uric acid re-absorption inhibitor that blocks the URAT1 transporter, treating the painful condition by normalizing acid excretion and reducing serum levels. In top-line results from a Phase III study on gout patients who get no benefit from allopurinol and febuxostat, lesinurad alone significantly reduced serum levels of uric acid, AstraZeneca said.

But what has analysts optimistic that lesinurad can cross the $1 billion threshold is the promise of combo treatments. AstraZeneca is in the midst of three more Phase III trials to suss out how the drug works in tandem with allopurinol or febuxostat, expecting to report data by mid-year. If those go well, a cocktail led by lesinurad could become a go-to treatment for physicians around the world, giving AstraZeneca a standard-bearing treatment for a growing global scourge.

Standing in its way, however, are some alarming safety issues that could spell trouble once lesinurad has its day at the FDA. In the Phase III monotherapy trial, the drug increased patients' risks of kidney trouble and led to a few serious adverse events, the company said, withholding specifics but saying that other side effects included diarrhea, nausea and constipation. Analysts will certainly be keeping an eye on any kidney risks with each new spate of Phase III data.

关键词： 阿斯利康 痛风 新药 lesinurad 三期临床研究 数据积极

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