Ardea Biosciences, Inc., a biotechnology company, focuses on the discovery and development of small-molecule therapeutics for the treatment of gout and cancer in the United States. Its product candidates include Lesinurad (RDEA594), an inhibitor of the URAT1 kidney transporter, which is in Phase III clinical trials for the treatment of gout; BAY 86-9766 (RDEA119), a mitogen-activated ERK kinase (MEK) inhibitor that is in Phase II clinical trials for the treatment of cancer; and RDEA3170, an URAT1 kidney transporter inhibitor, which is in Phase I clinical trials for the treatment of gout. The company has a development and commercialization license agreement with Bayer Healthcare AG to develop...
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Ironwood Pharmaceuticals Enters into U.S. Licensing Agreement with Ardea Biosciences, Inc. for Lesinurad
Apr 26 16
On April 26, 2016, Ironwood Pharmaceuticals, Inc. and Ardea Biosciences, Inc. (“Ardea”), an indirect wholly owned subsidiary of AstraZeneca PLC, entered into a license agreement pursuant to which Ardea granted to Ironwood a license for the commercialization, and the development, manufacture and support of such commercialization, of products containing lesinurad as an active ingredient, including Zurampic, in the United States. Subject to the terms of the License Agreement, Ardea will conduct certain development activities on Ironwood’s behalf for (i) Zurampic (including the post-marketing requirement activities currently required by the Food and Drug Administration, for which Ironwood will reimburse Ardea up to $100 million over up to ten years), and (ii) a fixed dose combination product with lesinurad and allopurinol as active ingredients, for which Ironwood will reimburse Ardea up to specified limits. Ironwood is responsible for any additional development of the Products for commercialization in the United States and for commercialization of the Products in the United States. In addition, under the terms of the License Agreement, Ironwood will have the right of first negotiation and a right of last refusal with Ardea for the right to commercialize (and develop and manufacture for commercialization) products comprising verinurad as at least one of its active ingredients for the prevention or treatment of gout in the United States. Pursuant to the terms of the License Agreement, Ironwood will make an upfront payment of $100 million to Ardea and will pay a royalty to Ardea in the single digits as a percentage of net sales of the Products in the United States (such royalty rate to be dependent on the aggregate net sales of the Products). Ardea is also eligible to receive $15 million following approval of the new drug application for the fixed dose combination product with lesinurad and allopurinol as active ingredients, as well as up to an aggregate of $150 million in additional commercial milestone payments over the term of the License Agreement, contingent on the achievement of certain net sales milestones in the United States. Subject to customary termination provisions, the License Agreement will continue as long as royalties are payable by Ironwood with respect to a Product.