Advicenne Receives Marketing Authorization and Reimbursement for Sibnayal® in UAE

PARIS--(BUSINESS WIRE)--Regulatory News:

Advicenne (Euronext Growth Paris - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases, obtains both marketing authorization (MA) and reimbursement status for its drug Sibnayal^® (fixed combination of potassium citrate and potassium bicarbonate) in the United Arab Emirates (UAE) for the treatment of distal Renal Tubular Acidosis (dRTA).

This MA is the second obtained for Sibnayal^® in the GCC countries after Kingdom of Saudi Arabia (KSA) last July. The reimbursement has been granted on an annual treatment cost comparable to that obtained in KSA and equivalent to the best European prices. These results reward the close collaboration between Advicenne and its local partner, Taiba Rare, one of the leading distributors of medicines in GCC. Advicenne holds the MA and Taiba Rare is marketing the product locally.

The incidence of dRTA in GCC is higher than in Europe and the United States, and the prevalence in the region can be estimated at approximately 1,000 to 1,200 people with the genetic form. Sibnayal^® is already being prescribed for early access in several GCC countries, including the United Arab Emirates.

Didier Laurens, Chief Executive Officer of Advicenne, stated: "This additional marketing authorization in one of the GCC countries results from the tireless efforts of the teams at Advicenne and Taiba Rare, whom I congratulate. Together, we are doing valuable work to convince the region's health authorities, and the reimbursed price recognizes the added value of the treatment. Our collaboration now enables patients to be treated for their distal Renal Tubular Acidosis (dRTA) in a region where the prevalence is among the highest in the world."

Saif Alhasani, Chief Executive Officer of Taiba Rare, added: “We are very proud to receive the marketing authorization for Sibnayal^®️ in the United Arab Emirates, marking our second marketing authorization in the GCC region following Saudi Arabia. This milestone reflects our strong commitment to addressing rare diseases in the region. I would like to sincerely thank our partner Advicenne for their continued trust and support. This approval represents important and positive news for the dRTA community in the UAE, where access to innovative and specialized treatments can make a meaningful difference in patients’ lives.”

About Advicenne
Advicenne (Euronext Growth Paris ALDVI - FR0013296746) 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.