AstraZeneca secures US launch for Zurampic

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AstraZeneca has entered into a licensing agreement with Ironwood Pharmaceuticals which includes US rights to Zurampic® and lesinurad/allopurinol fixed-dose combination in gout.

The agreement confers the exclusive US rights to Zurampic (lesinurad) to Ironwood. Zurampic was approved by the US Food and Drug Administration (FDA) in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.

Ironwood will additionally gain the exclusive US rights to the fixed-dose combination of lesinurad and allopurinol. AstraZeneca plans to submit the fixed-dose combination programme for regulatory review in the second half of 2016.

Ironwood will pay AstraZeneca sales-related and other milestone payments of up to $265 million and tiered single-digit royalties on product sales. AstraZeneca will manufacture and supply Zurampic, provide some support and services to Ironwood and undertake the FDA post-approval commitment on their behalf.

Luke Miels, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca, said: “Our new agreement with Ironwood will ensure the successful launch of Zurampic in the US, while allowing us to concentrate our resources on the innovative medicines in our main therapy areas.”

The licensing agreement is expected to close in the second quarter of 2016, subject to antitrust approval in the US.