The French metabolic experts at Poxel have reversed course on their planned solo development mission in Japan, lining up an Asian partner for their late-stage diabetes drug imeglimin.
Sumitomo Dainippon Pharma stepped up with a $42 million upfront, with promises of $24 million more for development milestones and about $233 million for hitting a slate of sales goals. In exchange they land marketing and development rights — they’ll be paying for the Phase III — in China, Japan and other key Asian countries.
Back in May, though, Poxel CEO Thomas Kuhn told me the biotech was planning to go at Phase III in Japan all by itself, a rare feat in the diabetes world, where a few key giants dominate the global landscape for a disease that has claimed millions of patients.
Investors didn’t mind, though, sending Poxel’s shares (EPA: $POXEL) rocketing up 43%.
The Merck Serono spinout had initially figured that it could pull off a Phase III program in Japan with 1,000 patients, far fewer than what would normally be expected. Poxel is styling imeglimin as a mitochondrial therapy that could protect beta cells, making it a good potential add-on. Its shares rocketed up 40% last May after a Phase IIb trial in Japan registered hemoglobin A1c reductions of 0.52%, 0.94% and 1.00% for the 500 mg, 1000 mg and 1500 mg dose twice-daily.
“Given imeglimin’s unique profile and novel mechanism of action, which we believe is well-suited for Asian patients, it has the potential to be a very important new oral therapy for the treatment of type 2 diabetes. With their very long and successful history of commercializing diabetes products and as a leader in this region with a dedicated franchise, Sumitomo Dainippon Pharma will be an excellent partner for imeglimin in Asia,” said Kuhn in a statement. “Our near-term focus in Japan is to initiate the Phase III program and to work closely with Sumitomo Dainippon Pharma to support the Japanese New Drug Application submission.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 28,000+ biopharma pros who read Endpoints News by email every day.Free Subscription