Clinical stage biopharmaceutical company Poxel SA (Euronext Paris:POXEL) announced on Monday that the Japanese Patent Office has granted a new patent (number 7635474) covering the use of Imeglimin in type 2 diabetic patients with moderate to severe renal impairment, extending protection in Japan until 2039.
This patent enhances Poxel's strategy to maximise Imeglimin's commercial potential in Japan and other markets.
The new patent strengthens TWYMEEG's position in Japan as Poxel's Japanese partner Sumitomo Pharma Co Ltd (TYO:4506) continues discussions with Japanese regulatory authorities to revise the package insert for patients with an estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73m2. Poxel previously obtained this patent in China, the world's second-largest type 2 diabetes market, supporting its efforts to expand Imeglimin's use internationally.
Topline results from a post-marketing clinical study conducted by Sumitomo Pharma in Japanese type 2 diabetic patients with renal impairment confirmed TWYMEEG's safety and tolerability, aligning with prior clinical data. Based on these findings, Sumitomo Pharma is seeking regulatory approval for label revisions, with an expected decision in the first half of 2025.
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