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 Takeda and 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.

Lesinurad was the center of AstraZeneca's $1.3 billion acquisition of Ardea Biosciences in 2012.

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