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.”
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