Date: 2014-01-13
Type of information: Milestone
Compound: NHE3 inhibitor programme including tenapanor, RDX5791
Company: AstraZeneca (UK) Ardelyx (USA)
Therapeutic area: Kidney diseases - Renal diseases - Metabolic diseases
Type agreement: licensing
Action mechanism: NHE3 is the sodium–hydrogen antiporter 3, a protein essential in the absorption of sodium in the intestines. RDX5791 is a minimally-absorbed, orally administered NHE3 sodium transport inhibitor. 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.
Disease: complications of renal disease, including diabetes-induced renal disease, chronic kidney disease
Details: AstraZeneca and Ardelyx have announced a worldwide exclusive licensing agreement for Ardelyx’s NHE3 inhibitor programme, including the Phase 2-ready lead compound RDX5791 tenapanor, for the treatment of complications associated with end-stage renal disease (ESRD) and chronic kidney disease (CKD). 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. Ardelyx targets specific gut transporters and receptors with drugs that address important medical issues in cardiovascular disease, diabetes and chronic kidney disease. With its approach, Ardelyx has developed drug candidates that exhibit restricted absorption across the gastrointestinal (GI) epithelia, thereby acting locally and specifically in the GI tract while avoiding systemic exposure and the potential for related systemic side effects.
Financial terms: 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.
Latest news: * On January 13, 2014, Ardelyx has announced it has received $15 million from AstraZeneca, representing a development milestone that was part of the collaboration agreement the companies had previously executed. AstraZeneca and Ardelyx announced the agreement in October 2012 under which AstraZeneca paid $35 million up front, and would pay development milestones of $237.5 million, as well as milestones related to launch and commercialization, in a worldwide exclusive licensing agreement for Ardelyx’s NHE3 sodium transport inhibitor program.
