09 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: AstraZeneca and Ardelyx entered into a worldwide exclusive licensing agreement for the latter's NHE3 inhibitor programme, including the phase II-ready lead compound RDX5791, for the treatment of complications associated with end-stage renal disease (ESRD) and chronic kidney disease (CKD). NHE3 is the sodium-hydrogen antiporter 3, a protein essential in the absorption of sodium in the intestines.
Ardelyx has evaluated RDX5791 in a phase IIa clinical trial in constipation-predominant irritable bowel syndrome (IBS-C) and in two phase I clinical studies in healthy subjects for its ability to divert sodium absorption in the gastrointestinal tract.
Under the terms of the agreement, AstraZeneca will pay $35 million up front, with development milestones of $237.5 million and milestones related to launch and commercialisation, as well as tiered, double-digit royalties. AstraZeneca will assume the subsequent development costs and Ardelyx will conduct clinical trials in phase II.
Mr Gunnar Olsson, VP and head of CVGI Innovative Medicines, AstraZeneca. "There is a significant unmet medical need to address the challenges caused by sodium and excess fluid in people with renal impairment. With a novel mechanism of action, RDX5791 has the potential to have a major impact on how doctors treat these patients. We are tremendously excited to join forces with the Ardelyx team and draw on their depth of knowledge and insight."
"We've been impressed with our interactions with AstraZeneca throughout this process and are confident with their commitment to develop this molecule successfully. AstraZeneca has been aggressive about pursuing novel medicines, making them among the best possible worldwide partners for validating Ardelyx's unique approach to drug development," commented Mr Mike Raab, CEO, Ardelyx.