Date: 2016-06-02
Type of information: Licensing agreement
Compound: Zurampic® (lesinurad)
Company: AstraZeneca (UK) Grunenthal (Germany)
Therapeutic area: Inflammatory diseases
Type agreement: licensing
Action mechanism: uric acid reabsorption inhibitor. Lesinurad is a selective uric acid reabsorption inhibitor (SURI) that inhibits the URAT1 transporter and is being studied as an investigational agent for the treatment of gout. URAT1 is responsible for the majority of the reabsorption of filtered uric acid from the renal tubular lumen. By inhibiting URAT1, lesinurad increases uric acid excretion and thereby lowers sUA. Lesinurad also inhibits OAT4, a uric acid transporter involved in diuretic-induced hyperuricaemia. Lesinurad has been developed by Ardea Biosciences, a member of the AstraZeneca Group. Zurampic® was approved by the European Medicines Agency (EMA) in February 2016, in combination with a xanthine oxidase inhibitor (XOI), for the adjunctive treatment of hyperuricemia (excess of uric acid in the blood) in adult patients with uncontrolled gout.
Disease: gout
Details: • On June 2, 2016, AstraZeneca announced that it has entered into a licensing agreement with Grünenthal for the exclusive rights to Zurampic® (lesinurad) in Europe and Latin America. 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.
Financial terms: Under the terms of the agreement, Grünenthal will submit the fixed-dose combination programme 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 1 October 2021, Grünenthal has the option to take over manufacturing of Zurampic®. Revenue from the licensing agreement will provide AstraZeneca with future recurring Externalisation Revenue from expected milestone payments and tiered, low double-digit percent royalty payments on Product Sales. The agreement does not impact AstraZeneca's financial guidance for 2016.
Latest news:
