AstraZeneca signs major deal with Grunenthal over Zurampic

Pharmaceutical and biologics company AstraZeneca announced on Thursday that it has entered into a licensing agreement with Grünenthal GmbH for the exclusive rights to Zurampic (lesinurad) in Europe and Latin America.

The FTSE 100 firm received approval from the European Medicines Agency in February for Zurampic, for the adjunctive treatment of hyperuricemia, or excess of uric acid in the blood, in adult patients with uncontrolled gout.

Under the terms of the deal, 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.

Additionally, Grünenthal will obtain the exclusive rights to a fixed-dose combination of lesinurad and allopurinol in those markets - the combination is currently in clinical trials.

Grünenthal will submit the fixed-dose combination programme or regulatory review, and will pay AstraZeneca up to $230m in sales and other related milestones over the lifetime of the contract under the terms of the agreement.

Grünenthal will also pay tiered, low double-digit royalties on annual product sales, while 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 from AstraZeneca.

“Grünenthal has an established presence across European and Latin American markets and extensive expertise in inflammatory diseases,” said AstraZeneca executive vice president, global product and portfolio strategy Luke Miels.

“This agreement allows us to further focus our resources on our strategic priorities.”

Grünenthal CEO Prof Dr Eric-Paul Pâques said the company was highly committed to the research, development and commercialisation of innovative therapies.

“Zurampic is a strong addition to our existing portfolio of innovative therapies in the areas of inflammatory diseases and chronic pain.

“We will thus use our capabilities to provide patients in our markets with this innovative new medicine to better control their condition,” Prof Dr Pâques explained.