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Zurampic

Ironwood Pharmaceuticals, Inc.

Drug Names(s): RDEA594

Description: RDEA594 is a major metabolite of RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI). RDEA594 does not have antiviral activity. Based on extensive in vitro and in vivo experiments, RDEA594 is believed to exhibit a concentration-dependent inhibitory effect on the URAT1 transporter-mediated uptake of uric acid, leading to more excretion of uric acid in the urine and lower blood levels.

RDEA594 has no effect on OAT1 and OAT3 transporters, and no interaction withantivirals or other drugs secreted by these transporters. There is limited metabolism by CYP450, with only slight induction. Half the drug is cleared through the kidney. It also has no mitochondrial toxicity, differentiating it from benzbromarone, a URAT1 transport inhibitor approved outside of the US in the early 2000s, but largely removed due to severe liver toxicity.

Deal Structure: Lesinurad was originally developed by Ardea.

AstraZeneca and Ardea
In April 2012, AstraZeneca and Ardea announced that they have entered into a definitive merger agreement, pursuant to which AstraZeneca will acquire Ardea. The acquisition was completed in June 2012.

AstraZeneca and Ironwood Pharmaceuticals
In April 2016, AstraZeneca and Ironwood Pharmaceuticals announced that they have entered into a licensing agreement for the exclusive US rights to Zurampic (lesinurad).

Under the terms of the agreement, Ironwood will make an up-front payment to AstraZeneca of $100 million to acquire exclusive U.S. rights to all products containing lesinurad, including the fixed-dose combination of lesinurad and allopurinol. AstraZeneca plans to submit the fixed-dose combination program for FDA regulatory review in the second half of 2016. Ironwood will pay AstraZeneca tiered single-digit royalties on product sales as well as sales-related and other milestones...See full deal structure in Biomedtracker

Partners: AstraZeneca PLC Grünenthal GmbH


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