• Patent life covering Imeglimin in China extended to 2039
• Ongoing partnership discussions to develop and market Imeglimin in China, the world's second largest type 2 diabetes market

LYON, France--(BUSINESS WIRE)-- Regulatory News:

POXEL SA (Euronext : POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announced that China's National Intellectual Property Administration (“CNIPA”) has granted Poxel patent ZL201980015603.X for Imeglimin, a first-in-class drug targeting mitochondrial dysfunction and marketed in Japan for the treatment of type-2 diabetes.

This new patent protects the use of Imeglimin for type-2 diabetic patients with moderate to severe renal impairment until 2039. The granting of the patent further supports ongoing discussions initiated by Poxel to develop and market Imeglimin in China, following the Company's recovery of the rights to this product in Asian countries other than Japan¹ from Sumitomo Pharma. The Company also holds 3 additional patents in China covering Imeglimin’s synthesis process.

The prevalence of diabetic patient with chronic kidney disease is high in China, corresponding to around 27% of the country's diabetic population, or nearly 32 million patients². Diabetes is also the leading cause of end-stage renal failure in this country, i.e. requiring dialysis or a kidney transplant.

China is one of Poxel's priority targets for the development and marketing of Imeglimin, where the decisions taken by the Japanese Agency for Pharmaceuticals and Medical Devices, could potentially reduce future regulatory and development times.

“The granting of this patent by the Chinese authorities is in line with our corporate development strategy and represents a partnering opportunity for a biotech company in this strategic territory. Indeed, the medical needs of the Chinese sub-population of type-2 diabetic patients with renal impairment are huge, and this sub-population is in great demand for a safe and efficacious therapeutic solution. We are pursuing our discussions with a view to a strategic partnership for the development and commercialization of Imeglimin, focusing primarily on China, South East Asian countries, as well as other very specific territories enabling us to maximize the approval of Imeglimin already achieved in Japan, thereby reducing the development efforts to be undertaken on a country-by-country basis”, stated Thomas Kuhn, Chief Executive Officer of Poxel.

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG^® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.
For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.

¹ China, South Korea, Taiwan, Indonesia, Vietnam, Thailand, Malaysia, The Philippines, Singapore, Republic of the Union of Myanmar, Kingdom of Cambodia and Lao People's Democratic Republic.
² Source: Chen et al. (2009) Nephrol Dial Transplant, Atkins et al. (2005) Kidney International, Robbins (2005) BMC public health

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Investor relations / Media

NewCap
Nicolas Fossiez, Aurélie Manavarere / Arthur Rouillé
investors@poxelpharma.com
+33 1 44 71 94 94

Source: Poxel

Released January 20, 2025