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Ironwood Pharmaceuticals signs US licensing agreement with AstraZeneca for lesinurad for hyperuricemia associated with uncontrolled gout.

M2 PHARMA-April 26, 2016-Ironwood Pharmaceuticals signs US licensing agreement with AstraZeneca for lesinurad for hyperuricemia associated with uncontrolled gout

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Pharmaceutical company Ironwood Pharmaceuticals (NasdaqGS:IRWD) reported on Monday the execution of a licensing agreement for the exclusive US rights to lesinurad from AstraZeneca for an up-front cash payment of USD100m.

The company said Lesinurad 200mg tablets were approved as ZURAMPIC by the US Food and Drug Administration (FDA) for use in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with uncontrolled gout, a serious, progressive and debilitating form of inflammatory arthritis.

This agreement allows Ironwood to acquire the exclusive US rights to all products containing lesinurad, including the fixed-dose combination of lesinurad and allopurinol as well as expects at least five US launches by 2020 across its portfolio.

Additionally, AstraZeneca plans to submit the fixed-dose combination programme for US FDA regulatory review in the second half of 2016. AstraZeneca will manufacture and supply ZURAMPIC, provide certain product support services to Ironwood and complete the FDA post-approval commitment on Ironwood's behalf.

In conjunction, Ironwood will pay AstraZeneca tiered single-digit royalties on product sales as well as sales-related and other milestones of up to USD165m.

Also, Ironwood expects to use less than USD70m in cash for operations in 2016. It also anticipates that positive cash flow during 2018 and commercial margins are expected to exceed 60% by 2022.

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Publication:M2 Pharma
Date:Apr 26, 2016
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