Date: 2016-04-26
Type of information: Licensing agreement
Compound: lesinurad
Company: AstraZeneca (UK) Ironwood Pharmaceuticals (USA - MA)
Therapeutic area: Inflammatory diseases
Type agreement: licensing
Action mechanism: selective uric acid re-absorption inhibitor (SURI). Lesinurad is an investigational agent being studied as a selective uric acid re-absorption inhibitor (SURI) that inhibits the URAT1 transporter, normalising uric acid excretion and reducing serum uric acid (sUA).
Disease: gout
Details:
- • On April 26, 2016, AstraZeneca announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic® (lesinurad). Zurampic® was approved by the FDA in December 2015, in combination with a xanthine oxidase inhibitor, for the treatment of hyperuricemia associated with uncontrolled gout.
- 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. AstraZeneca 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.
- 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, including RDEA3170, a Phase IIb ready, potent selective uric acid reabsorption inhibitor. Under the terms of 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.
Financial terms: Ironwood will pay AstraZeneca sales-related and other milestone payments of up to $265 million and tiered single-digit royalties on Product Sales. 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.
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