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Chart - After Uloric: Pipeline Shows Interest Crystallizing In Gout Market

This article was originally published in Pharmaceutical Approvals Monthly

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After Uloric: Pipeline Shows Interest Crystallizing In Gout Market



After Uloric: Pipeline Shows Interest Crystallizing In Gout Market

Sponsor/Drug

Category

Status

Savient Krystexxa (pegloticase, formerly Puricase)

Pegylated recombinant urate oxidase for treatment-failure gout

BLA pending with a user fee goal of 7/30/2009 following recent BLA amendments including cardiovascular data and revised REMS

Regeneron Arcalyst (rilonacept)

Interleukin-1 blocker for acute gout flare during allopurinol therapy

Phase III trials planned after late 2008 meeting with FDA

Ardea Biosciences' RDEA806

Non-nucleoside reverse transcriptase inhibitor that lowers uric acid levels

Phase IIa proof-of-concept trial to complete in Q1 2009; all further gout studies will be conducted with a metabolite, RDEA594

Ardea Biosciences' RDEA594

Inhibitor of the uric acid transporter URAT-1

Phase I ascending-dose study complete; Phase II planned for the first half of 2009

EnzymeRx's Uricase-PEG 20 (pegylated recombinant urate oxidase)

Pegylated recombinant Candida utilis urate oxidase (uricase) for resistant and refractory gout

Phase I dose escalation study complete; EnzymeRx is currently finishing preclinical toxicology studies and analyses requested by FDA, but plans to resume clinical development later in 2009

Altus' ALTU-242

Orally delivered enzyme

Preclinical stage, but Altus has announced plans to re-align priorities to focus on a growth hormone candidate

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