Date: 2015-09-01
Type of information: Termination of an agreement
Compound: phosphate transport NaP2b inhibitor program (also known as NaPi2b, Npt2b and SLC34A2)
Company: Ardelyx (USA - CA) Sanofi (France)
Therapeutic area: Renal diseases - Kidney diseases
Type agreement: termination of a licensing agreement
Action mechanism: NaP2b is an intestinal phosphate transporter whose activity accounts for a significant portion of dietary phosphate absorption in humans. The inhibition of NaP2b should have utility for the treatment of hyperphosphatemia (elevated serum phosphate) in patients with end stage renal disease (ESRD) and other forms of chronic kidney disease (CKD).
Disease:
Details: * On February 24, 2014, Ardelyx has announced that it has licensed to Sanofi its novel phosphate transport NaP2b inhibitor program (also known as NaPi2b, Npt2b and SLC34A2). Ardelyx’s NaP2b program includes a portfolio of minimally-absorbed NaP2b inhibitors in discovery and preclinical stage of development, and Sanofi will have full responsibility for further discovery efforts and development of any products.
Financial terms: Ardelyx will receive an undisclosed upfront payment from Sanofi. Total development and regulatory milestones could potentially reach up to $198 million. Ardelyx would also be entitled to royalties on product sales. In addition, Ardelyx retains an option to participate in co-promotional activities for the US market.
Latest news: * On September 1, 2015, Ardelyx announced that Sanofi notified Ardelyx of its termination of the option and license agreement for Ardelyx's portfolio of NaP2b inhibitors effective September 30, 2015. There was no payment associated with termination and the return of rights. In February 2014, Ardelyx and Sanofi entered into an option and license agreement under which Ardelyx granted Sanofi an exclusive worldwide license to conduct research utilizing Ardelyx's small molecule NaP2b inhibitors, also called RDX002, for the treatment of hyperphosphatemia in ESRD patients. If a development candidate were identified within a defined period, Sanofi could exercise its option to obtain an exclusive license to develop, manufacture and commercialize Ardelyx's NaP2b inhibitors. Ardelyx received an upfront payment of $1.25 million upon execution of the agreement. The NaP2b inhibitors are all in early stage research. "The return of the research portfolio of NaP2b inhibitors allows Ardelyx to expand its knowledge of all aspects of phosphate management, complementing tenapanor, which is being evaluated in mid-stage clinical trials for the treatment of hyperphosphatemia in ESRD patients," said Mike Raab, Ardelyx's President and CEO.
