Biotech Values

[DewDiligence]

Potential competition for ABT/Reata’s Bardoxolone:

http://www.astrazeneca.com/Media/Press-releases/Article/20121008--astrazeneca-and-ardelyx-announce

AstraZeneca and Ardelyx today announced a worldwide exclusive licensing agreement for Ardelyx’s NHE3 inhibitor programme, including the Phase 2-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 2a clinical trial in constipation-predominant irritable bowel syndrome (IBS-C) and in two Phase 1 clinical studies in healthy subjects for its ability to divert sodium absorption in the gastrointestinal tract. Through its unique mechanism of action, RDX5791 is believed to decrease the absorption of dietary sodium and thus divert sodium excretion from the kidney (urine) to the faeces, sparing the kidney and the cardiovascular system from unhealthy exposure of both sodium and fluid accumulation. On this basis, the companies plan to develop RDX5791 for use in ESRD and CKD in addition to IBS-C, and intend to evaluate possible development in other diseases that are a consequence of sodium and fluid overload.

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 2. As part of the transaction, Ardelyx has secured an option to co-promote the product in the US, subject to agreed limitations. Additional financial details were not disclosed.

This is far short of the blockbuster deal ABT inked with Reata for the ex-US rights to Bardoxolone in 2010 (#msg-54747777), which had $450M (!) up-front; however, Bardoxolone was already in phase-2 when the ABT-Reata deal was inked, while RDX5791 is merely “phase-2 ready.”