AstraZeneca entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive U.S. rights to ZURAMPIC (lesinurad). ZURAMPIC was approved by the U.S. FDA in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.
Ironwood will not only acquire exclusive U.S. rights to ZURAMPIC, but also gain the exclusive U.S. rights to the fixed-dose combination of lesinurad and allopurinol, according to a press release. AstraZeneca plans to submit the fixed-dose combination program 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 says it will manufacture and supply ZURAMPIC, provide certain support and services to Ironwood and undertake the FDA post-approval commitment on their behalf.
The development of AstraZeneca’s gout portfolio is led by Ardea Biosciences, a wholly owned subsidiary. The transaction does not include the transfer of any AstraZeneca or Ardea employees or facilities. AstraZeneca also retains the rights to the rest of the Ardea portfolio. The licensing agreement is expected to close in the second quarter of 2016.