Advicenne Receives Marketing Authorization and Reimbursement for Sibnayal® in Saudi Arabia

28 Jul 2025 07:30 CEST

Regulatory News:

Advicenne (Euronext Growth® - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases, obtains marketing authorization (MA) and reimbursement status for Sibnayal® (a fixed combination of potassium citrate and potassium bicarbonate) in the Kingdom of Saudi Arabia (KSA).

Marketing authorization for Sibnayal® (ADV7103) in distal Renal Tubular Acidosis (dRTA) in KSA has been granted, based on the European registration dossier. Furthermore, Saudi authorities have agreed a reimbursement rate in line with the best European pricing.

This achievment results of a close collaboration between Advicenne and its local partner, Taïba Healthcare, a leading distributor of pharmaceutical products in the Gulf region. Advicenne will act as the marketing authorization holder, while Taïba Healthcare will manage local marketing activities.

The incidence of dRTA is higher in Gulf countries than in Europe or the United States, and prevalence in KSA could be estimated around 600 to 800 patients. Sibnayal® is already prescribed through early access programs in several Gulf countries outside Saudi Arabia. This milestone paves the way for registrations in GCC countries where the application is filed.

Didier Laurens, CEO of Advicenne, declared: “I am particularly proud of this important achievement and wish to congratulate both Advicenne and Taïba Healthcare teams, whose efforts were instrumental in informing and convincing the Saudi health authorities. The reimbursement obtained, comparable to the highest levels recorded in Europe, further attests to the significant therapeutic value of Sibnayal® in a region with one of the highest prevalence rates of dRTA worldwide.”

About Advicenne
Advicenne (Euronext: ALDVI) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal® (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU and GB. ADV7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US and in Canada. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022.

For additional information, see: https://advicenne.com/.

Disclaimer
This press release contains certain forward-looking statements concerning Advicenne group and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Advicenne considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the 2024 Universal Registration Document filed with the French financial market authority on April 29, 2025 (a copy of which is available on www.advicenne.com) and to the development of economic conditions, financial markets and the markets in which Advicenne operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Advicenne or not currently considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Advicenne to be materially different from such forward-looking statements. Advicenne expressly declines any obligation to update such forward-looking statements.

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Advicenne
Didier Laurens, Directeur Général
+33 (0) 1 87 44 40 17
Email: investors@advicenne.com

Ulysse Communication
Media relations
Bruno Arabian
+33 (0)6 87 88 47 26
Email: advicenne@ulysse-communication.com