AstraZeneca has entered into a licensing agreement with Grünenthal GmbH for the exclusive rights to Zurampic (lesinurad) in Europe and Latin America. Zurampic was approved by the European Medicines Agency in February 2016, in combination with a xanthine oxidase inhibitor, for the adjunctive treatment of hyperuricemia (excess of uric acid in the blood) in adult patients with uncontrolled gout.

Grünenthal will acquire the exclusive rights to Zurampic in all 28 European Union member states, Switzerland, Iceland, Norway, and Lichtenstein, and in all Latin-American countries including Mexico, the Dominican Republic and Cuba. In addition, Grünenthal will also obtain the exclusive rights to the fixed-dose combination of lesinurad and allopurinol in these markets. This combination is currently in clinical trials.

Under the terms or the agreement, Grünenthal will submit the fixed-dose combination program for regulatory review and will pay AstraZeneca up to $230 million in sales and other related milestones over the lifetime of the contract. Grünenthal will also pay tiered, low double-digit royalties on annual product sales. AstraZeneca will initially manufacture and supply Zurampic to Grünenthal and will undertake the European post-approval commitment on Grünenthal's behalf. From October 1, 2021, Grünenthal has the option to take over manufacturing of Zurampic.

In separate news, AstraZeneca has completed the licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic (lesinurad) and the fixed-dose combination of lesinurad and allopurinol. Zurampic is approved in the US, in combination with a xanthine oxidase inhibitor, for the treatment of hyperuricemia associated with uncontrolled gout. The fixed-dose combination will be submitted for regulatory review in the second half of 2016.

Source: AstraZeneca (Grünenthal) and AstraZeneva (Ironwood)