AstraZeneca (AZ) has entered into a definitive agreement to acquire Ardea Biosciences, a biotechnology company based in San Diego and focused on the development of small-molecule therapeutics. Under the terms of the agreement, AZ will pay $32 per share, which represents a total cash value of approximately $1.26bn, including existing cash.
Ardea’s clinically most advanced product candidate, lesinurad (formerly known as RDEA594), is currently in Phase III development as a potential treatment for the chronic management of hyperuricaemia in patients with gout.
Lesinurad is a selective inhibitor of URAT1, a transporter in the proximal tubule cells of the kidney that regulates uric acid excretion from the body, which is being developed as an oral, once-daily treatment. It is being studied in an ongoing Phase III clinical development programme as an add-on treatment to allopurinol in patients not reaching target serum uric acid levels on allopurinol alone, as monotherapy for those patients who are intolerant to allopurinol or febuxostat and as an add-on treatment to febuxostat in patients with tophaceous gout.
Filings for a New Drug Application (NDA) in the US and a Marketing Authorisation Application (MAA) in the EU are planned for the first half of 2014. AZ also plans to develop and commercialise lesinurad in China and Japan. The company will seek to absorb the further development costs of the Ardea compounds in its existing r&d programme.
Through this acquisition, AstraZeneca would also add to its pipeline RDEA3170, a next-generation selective URAT1 inhibitor currently in Phase I development.
‘This attractive Phase III programme is an excellent opportunity to leverage AstraZeneca’s global speciality and primary care sales and marketing capabilities,’ said David Brennan, ceo of AstraZeneca. ‘The Ardea team has done a great job developing lesinurad along with a promising next-generation gout programme. These compounds have real potential to benefit patients.’
Subject to the approval of Ardea’s shareholders as well as other conditions including customary regulatory approvals, the transaction will close in the second or third quarter of 2012.