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Ardea Biosciences Announces Positive End-of-Phase 2 Meetings with FDA for Lesinurad
Date:9/7/2011

will evaluate the effect of adding lesinurad to allopurinol in patients who do not reach target sUA levels on allopurinol alone. The interventional study will also help identify allopurinol-intolerant patients who would be eligible for the Company's Phase 3 study of lesinurad monotherapy for patients in whom allopurinol is contraindicated. A Phase 3 study of lesinurad in combination with febuxostat is also planned.

"We are very gratified with the positive outcome and clear feedback from the FDA at our End-of-Phase 2 meetings," commented Barry D. Quart, PharmD, Ardea's president and chief executive officer. "We were also very pleased to have recently initiated our allopurinol interventional trial, as it is an important first step in the efficient and effective conduct of our overall Phase 3 program for lesinurad.  It should help expedite overall enrollment in the main portion of our Phase 3 program by enabling us to identify ahead of time eligible patients to participate in our studies."

About Hyperuricemia and Gout

Gout is a painful, debilitating and progressive disease caused by abnormally elevated levels of uric acid in the blood stream.  This leads to the deposition of painful, needle-like uric acid crystals in and around the connective tissue of the joints and in the kidneys, resulting in inflammation, the formation of disfiguring nodules, intermittent attacks of severe pain and kidney damage.  In addition, evidence suggests that the chronic elevation of uric acid associated with gout, known as hyperuricemia, may also have systemic consequences, including an increased risk for kidney dysfunction and cardiovascular disease.

In 2008, approximately 8.3 million patients in the U.S., 9 million patients in the European Union and 2.9 million patients in Japan had been diagnosed with gout.  Gout is the most common form of inflammatory arthritis in men over the age of 40 and represents a significant unmet medical n
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SOURCE Ardea Biosciences, Inc.
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8. Ardea Biosciences Announces Positive Top-Line Results from Phase 2b Combination Study of RDEA594 in Allopurinol-Refractory Gout Patients
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