Advicenne Announces Commercial Launch of Sibnayal® in Great Britain

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

Advicenne (Euronext Growth Paris ALDVI - FR0013296746), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases, is pleased to announce that Sibnayal®, combination of potassium citrate and potassium bicarbonate, has been made available to patients suffering from distal Renal Tubular Acidosis (dRTA) in Great Britain.

Sibnayal® has been approved in Great Britain since July 2021. Sibnayal® has been added on the Department of Health list of drugs and is immediately available for doctors and patients in its indication.

Advicenne has obtained, from the National Health Service (NHS) the selling price of Sibnayal® in Great-Britain and is now actively working to provide the National Institute for Health and Care Excellence (NICE) with additional information allowing positive opinion on the prescription’s guidance of Sibnayal®. The next session with NICE is planned on August 4^th.

Didier Laurens, Chief Executive Officer of Advicenne, commented: “We are delighted to officially make Sibnayal® available to British patients and caregivers. It is the conclusion of a long journey from the development of the product, its EMA and MHRA approval and finally being commercialized. If we still need to finalize the reimbursement process of Sibnayal®, we are confident in our ability to conclude positively and give patients an easier access to a drug which is changing their daily living. We all worked hard to reach this first milestone and Sibnayal® commercial journey is on. Our role now is to turn it into a success for all stakeholders.”

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^TM (ADV 7103) has received its Marketing Approval for distal renal tubular acidosis in EU and the UK. ADV 7103 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 2021 Universal Registration Document filed with the French financial market authority on April 29, 2022 (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.