Grünenthal will acquire 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 lesinurad fixed-dose combination (FDC) i.e. with allopurinol in these markets. This combination is currently in clinical trials.
Under the terms of the agreement, Grünenthal will submit the fixed-dose combination programme for regulatory review and will pay AstraZeneca up to $250 million in sales and other milestones. Grünenthal will also pay tiered royalties on annual Product Sales up to low double digits. AstraZeneca will initially manufacture and supply Zurampic™ to Grünenthal and will undertake the EMA post-approval commitment on their behalf. After 30 September 2021, Grünenthal has the option to take over manufacture of Zurampic™. The agreement adds to the Grünenthal portfolio which consists of innovative therapies in the areas of inflammation, chronic pain and rare diseases.
Prof. Dr. Eric-Paul Pâques, CEO Grünenthal said: “We are highly committed to the research, development and commercialization of innovative therapies that bring true benefits to patients. 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.”
Luke Miels, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca, said: “Grünenthal has an established presence across European and Latin American markets and extensive expertise in inflammatory diseases. This agreement, along with the agreement we recently entered into with Ironwood in the US, allows us to ensure the successful launch of Zurampic in key markets working with experienced partners, while we continue to focus our resources around our strategic priorities.”
Gout is a serious, chronic, progressive and potentially debilitating form of inflammatory arthritis that affects more than 7.8 million people in the major European and Latin American markets¹.
As a privately owned mid-cap pharmaceutical company, Grünenthal has a long track-record of successful partnerships and wants to build on this success to achieve maximum growth and revenues in its core business pain while expanding additional growth indications. This includes therapies that fit Grünenthal’s current target groups in the European and Latin American markets. Grünenthal’s R&D pipeline consists of several projects in the area of inflammatory diseases.
NOTES TO EDITORS
¹Markets include France, Germany, Italy, Spain, United Kingdom, Brazil, Mexico, Colombia, and Argentina. Source: Decision Resources Group, Community Oriented Programme for Control of Rheumatic Diseases.
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. Zurampic is not recommended for the treatment of asymptomatic hyperuricemia and should not be used as monotherapy. XOIs reduce the production of uric acid; Zurampic increases the excretion of uric acid. Together, the combination of Zurampic and an XOI 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. Zurampic selectively inhibits the function of transporter proteins urate transporter (URAT1) and organic anion transporter 4 (OAT4), involved in uric acid reabsorption in the kidney. In people, Zurampic does not inhibit OAT1 and OAT3, which are drug transporters in the kidney associated with drug-drug interactions. The efficacy of Zurampic was established in three Phase III clinical trials that evaluated a once daily dose of Zurampic in combination with the XOIs allopurinol or febuxostat compared to XOI alone.