AstraZeneca, IronWood Pharmaceuticals Sign Licensing Deal for Gout DrugBy
AstraZeneca has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic (lesinurad). 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.
Under 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. 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 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. of AstraZeneca and based in San Diego, California. 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, including RDEA3170, a Phase IIb ready, potent selective uric acid reabsorption inhibitor. Under the agreement, Ironwood will have certain rights to potentially access RDEA3170 in gout indications in the US. The licensing agreement is expected to close in the second quarter of 2016, subject to antitrust approval in the US.
Zurampic (lesinurad) is the first in a new class of medicines called selective uric acid reabsorption inhibitors (SURI) that work selectively to complement xanthine oxidase inhibitors (XOIs) in the treatment of hyperuricemia associated with uncontrolled gout. XOIs reduce the production of uric acid; Zurampic increases the excretion of uric acid. Together, the combination provides a dual mechanism of action that both decreases production and increases excretion of uric acid, thereby lowering serum uric acid (sUA) levels in patients who have not achieved target serum acid levels with XOI treatment alone.