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Re: DewDiligence post# 183917

Sunday, 11/16/2014 3:31:40 PM

Sunday, November 16, 2014 3:31:40 PM

Post# of 257257
AZN's lesinurad:

This is just detailed presentation from previously announced top line result in Aug:

http://www.astrazeneca.com/Media/Press-releases/Article/13082014--astrazeneca-announces-topline-results-from-the-phase

Not surprising AZN doesn't present detailed result from CRYSTAL announced together in Aug where 200mg didn't meet primary endpoint:

In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone (p<0.0001). Although lesinurad 200mg did not achieve statistical significance at month 6 (p=0.13), this dose in combination with febuxostat, was superior to placebo plus febuxostat at all other time points (measured at months 1 to 5, 8, 10 and 12; nominal p<0.05).



FierceBiotech summarized ALL ph3 results well here - AZN plans to file regulatory submission for 200mg only due to AEs from 400mg:

http://www.fiercebiotech.com/story/astrazenecas-phiii-gout-data-lesinurad-includes-hit-strikeout-and-missing-p/2014-11-16

Overall, lesinurad data don't meet my expectation. Glad AZN bought RDEA smile

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