AstraZeneca said today it has granted exclusive rights to the gout-associated hyperuricemia drug Zurampic® (lesinurad) in Europe and Latin America to Grünenthal, in a licensing deal that could generate up to $230 million-plus for the pharma giant.
The agreement comes more than a month after AstraZeneca granted U.S. licensing rights to Zurampic to Ironwood Pharmaceuticals for up to $265 million plus royalties.
In the latest deal, Grünenthal agreed to acquire exclusive rights to Zurampic in all 28 EU member states, as well as Switzerland, Iceland, Norway, and Lichtenstein—and in all Latin American countries, including Mexico, the Dominican Republic, and Cuba.
The agreement also gives Grünenthal exclusive rights to the fixed-dose combination of lesinurad and allopurinol, which is now in clinical trials. Grünenthal has agreed to submit the fixed-dose combination program for regulatory review.
Grünenthal has agreed to pay AstraZeneca up to $230 million in payments tied to achieving sales and other related milestones, as well as pay tiered, low double-digit royalties on annual product sales.
AstraZeneca said it will initially manufacture and supply Zurampic to Grünenthal and will undertake the European postapproval commitment on Grünenthal’s behalf. Grünenthal has the option to take over manufacturing of Zurampic as of October 1, 2021.
“Grünenthal has an established presence across European and Latin American markets and extensive expertise in inflammatory diseases. This agreement allows us to further focus our resources on our strategic priorities,” Luke Miels, evp, global product and portfolio strategy, AstraZeneca, said in a statement.
AstraZeneca’s therapeutic areas are cardiovascular and metabolic disease, oncology, and respiratory, inflammation, and autoimmunity diseases.
Grünenthal focuses its R&D on treatments for acute and chronic nociceptive pain, chronic neuropathic pain, and mixed pain.
Zurampic is designed to work by selectively inhibiting the function of transporter proteins urate transporter (URAT1) and organic anion transporter 4 (OAT4), involved in uric acid reabsorption in the kidney.
AstraZeneca acquired Zurampic in 2012 when it paid $1.26 billion for Ardea Biosciences, now a wholly owned subsidiary of the pharma giant. AstraZeneca retains ownership of the rest of the Ardea portfolio—including RDEA3170, a Phase IIb-ready, potent, selective uric acid reabsorption inhibitor.
The European Medicines Agency (EMA) in February approved the combination of Zurampic and a xanthine oxidase inhibitor (XOI) for adjunctive treatment of hyperuricemia in adult patients with uncontrolled gout. The FDA approved the Zurampic–XOI combination in December 2015.
AstraZeneca said the agreement does not impact its financial guidance for 2016. The pharma giant has told investors it anticipates “low to mid single-digit percentage” declines in both total revenue and core earnings per share.