Grünenthal and AstraZeneca Enter Into License Agreement for lesinurad in Europe and Latin America

AACHEN, Germany, June 2, 2016 /PRNewswire/ --

• Agreement includes exclusive rights to Zurampic™ and the fixed-dose combination of lesinurad and allopurinol 
• Agreement enriches Grünenthal portfolio in the area of inflammatory and pain-related diseases with high unmet need  

Grünenthal Group today announced that it has entered into a licensing agreement with AstraZeneca for the exclusive rights to Zurampic^™ (lesinurad) in Europe and Latin America. Zurampic™ was approved by the European Medicines Agency (EMA)in February 2016, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of adjunctive hyperuricemia in adult patients with uncontrolled gout.

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 $230 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.

About Zurampic™ 

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.

About Grünenthal  

The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. We are an entrepreneurial specialist delivering true benefits to patients. By sustainably investing in research and development above the industrial average, we are committing to innovation in order to treat unmet medical needs and bring value adding products to markets. Grünenthal is a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. Altogether, the Grünenthal Group is present in 32 countries with affiliates in Europe, Latin America and the US. Grünenthal products are sold in more than 155 countries and approx. 5,300 employees work for the Grünenthal Group worldwide. In 2015, Grünenthal achieved revenues of €1.2 bn. More information: http://www.grunenthal.com.

About AstraZeneca 

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology - as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: http://www.astrazeneca.com

Contact: Steffen Fritzsche, Head Global Corporate Communications, Tel: +49-241-569-1335, [email protected]

Grünenthal GmbH, 52099 Aachen, Germany, http://www.grunenthal.com

SOURCE Grunenthal Pharma GmbH & Co. KG.