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AZ pays $273m for Ardelyx renal disease drug

Phase II candidate could tackle fluid overload in kidney and heart disorders

AstraZeneca (AZ) has licensed worldwide rights to a drug in phase II trials for kidney disease from US company Ardelyx in a deal valued at $272.5m.

The agreement covers RDX5791, a selective inhibitor of a sodium transporter (NHE3) found on the surface of intestinal epithelial cells. 

The drug decreases absorption of dietary sodium and so diverts sodium excretion from urine to the faeces, sparing the kidney and the cardiovascular system from exposure to excess sodium and fluid accumulation.

Ardelyx hopes the drug will be able to tackle fluid overload in kidney and heart disorders such as end-stage renal disease (ESRD), chronic kidney disease (CKD), and heart failure, and also treat constipation disorders such as constipation-predominant irritable bowel syndrome (IBS-C).

Ardelyx has completed a phase IIb trial in IBS-C and two phase I studies that indicate the drug can divert sodium absorption from the kidney to the gastrointestinal tract.

AZ has paid $35m upfront to license RDX5791 in ESRD, CKD and IBS-C, as well as "other diseases that are a consequence of sodium and fluid overload". 

The deal also includes development milestone payments of $237.5m, additional payments related to launch and commercialisation, as well as tiered, double-digit royalties on sales.

"There is a significant unmet medical need to address the challenges caused by sodium and excess fluid in people with renal impairment," said AZ vice president Gunnar Olsson, who heads the firm's cardiovascular and gastrointestinal (CVGI) innovative medicines (iMed) group.

"This licensing agreement accelerates our strong commitment to developing new medicines for people with renal complications, including those resulting from diabetes," he added.

The deal comes after AZ halted a share buyback programme after achieving just 50 per cent of its target, raising speculation that it wanted to free up cash for acquisitions.

The company needs to bolster its pipeline in the wake of a series of late-stage failures, including Targacept-partnered antidepressant TC-5214, olaparib in ovarian cancer and motavizumab for respiratory syncytial virus (RSV), and the loss of patent protection on some of its biggest-selling brands.

8th October 2012

From: PME

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