Ironwood To Acquire Exclusive US Rights To Gout Drug Zurampic From AstraZeneca

(RTTNews) - AstraZeneca (AZN.L, AZN) Tuesday announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals (IRWD) for the exclusive US rights to Zurampic (lesinurad).

Under the terms of the agreement, Ironwood will acquire exclusive US rights to Zurampic. In addition, Ironwood will gain the exclusive US rights to the fixed-dose combination of lesinurad and allopurinol. Ironwood will pay AstraZeneca sales-related and other milestone payments of up to $265 million and tiered single-digit royalties on Product Sales.

Zurampic was approved by the US Food and Drug Administration or FDA in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.

AstraZeneca said it plans to submit the fixed-dose combination programme for regulatory review in the second half of 2016. AstraZeneca will manufacture and supply Zurampic, provide certain support and services to Ironwood and undertake the FDA post-approval commitment on their behalf.

Revenue from the licensing agreement will provide AstraZeneca with recurring Externalisation Revenue from any expected milestone payments and tiered single-digit royalty payments on Product Sales. The agreement does not impact AstraZeneca's financial guidance for 2016. Gout is a serious, progressive and debilitating form of inflammatory arthritis.