Poxel’s imeglimin boasts a particularly protracted development history, but the end of the road might finally have been reached, outside of Japan. The latest delay concerns partner Metavant, which after months of regulatory discussions and deliberations has walked away from the diabetes asset. The Roivant subsidiary owned rights in the US and Europe and had planned to push forward in patients with type 2 diabetes and chronic kidney disease; it seems probable that Metavant was put off by the size and scope of the pivotal programme deemed necessary, while recent clinical success with SGLT2 inhibitors have raised the bar. Poxel shares dipped only 10% on the news, suggesting that hope for progress here was already low – the French company at least has progress in Japan to fall back on. Here, partner Sumitomo Dainippon recently filed imeglimin for approval in type 2 diabetes. Sumitomo and Roivant are of course intertwined via a large deal consummated last year, which included an option over Metavant. The Japanese pharma’s deal with Poxel predates the Roivant transaction, suggesting that Sumitomo is satisfied with the extent of its ownership of imeglimin. Finding a new partner will be tough.
|A protracted development path for imeglimin|
|2009||Poxel spins out of Merck KGaA with imeglimin|
|2017||Poxel completes phase IIb development of imeglimin|
|Oct 2017||Sumitomo Dainippon buys Japan, China and other SE Asian rights to imeglimin for $42m up front and up to $260m in milestones, plus double-digit royalites|
|Dec 2017||Phase III programme begins in Japan|
|Feb 2018||Roivant buys remaining global rights (incl US and EU) to imeglimin for $35m up front and up to $600m in milestones, plus double-digit royalites; Poxel to contribute $25m to development costs|
|Mar 2018||Roivant forms Metavant subsidiary to take forward imeglimin|
|Mid-2018||Metavant decides to take imeglimin forward in type 2 diabetes with chronic kidney disease|
|Late 2019||Three-trial pivotal Japanese programme successfully completed|
|Jul 2020||Imeglimin filed for approval in Japan|
|Nov 2020||Metavant hands back rights to imeglimin to Poxel, deciding not to push into phase III|
|Source: company statements.|
This article has been corrected to clarify that the Sumitomo-Roivant deal included an option over Metavant.