Dive Brief:
- French company Poxel SA has licensed worldwide development and commercialization rights outside Southeast Asia for its diabetes candidate imeglimin to Roivant Sciences Ltd.
- Poxel snagged an upfront payment of $35 million, and could receive milestone payments of up to $600 million plus double-digit royalties on net sales. Switzerland-based Roivant will also make a $15 million investment in Poxel through a share subscription.
- While Roivant is responsible for development and commercialization costs, Poxel has agreed to contribute $25 million to imeglimin's development. Phase 3 trials are planned for 2019.
Dive Insight:
Roivant's strategy is to in-license candidates in "underserved therapeutic areas" going through late-stage development.
To that end, the company has 15 investigational drugs in seven different therapeutic areas. And while Roivant has two drugs in endocrinology, imeglimin will be first type 2 diabetes drug.
"This agreement represents the beginning of our focus on metabolic diseases and imeglimin … will be a cornerstone program," Vivek Ramaswamy, founder and CEO of Roivant Sciences, said in a statement Monday.
The deal will allow Poxel to increase its focus on its earlier-stage pipeline. This includes PXL-770, an AMPK activator currently in Phase 1 trials. A Phase 2a trial is planned for the second part of 2018, in the growing field of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
Poxel also has three type 2 diabetes discovery programs, focusing on oral GLP-1 agonists, GK activators and 11 beta HSD1 inhibitors.
According to Poxel SA, imeglimin has potential in early use as a monotherapy for patients who can't take metformin. It could also be used in two- or three-drug combinations, and may delay the need for injectable treatments.
Development plans, which Roivant will pick up, are currently focused on additional mid-stage investigations in 2018, including differentiation studies in certain populations, such as those with kidney disease. Phase 3 trials are expected to begin in the U.S. and Europe in 2019.
Meanwhile, Poxel CEO Thomas Kuhn said the late-stage TIMES study, which is based in Japan and evaluating imeglimin as a treatment for Type 2 diabetes, has begun. An approval filing should hit Japanese regulators' desk in 2020.
In October 2017, Sumitomo Dainippon Pharma picked up rights to imeglimin for 12 Southeast Asian countries — including China, South Korea and Taiwan — in a deal that could be worth $300 million.