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 update about the market access of Sibnayal® in Great Britain. Sibnayal® is a combination of potassium citrate and potassium bicarbonate.
Sibnayal® has been accepted for use within NHS Scotland. This positive decision by the Scottish Medicines Consortium (SMC) makes Sibnayal® immediately available to all Scottish distal Renal Tubular Acidosis (dRTA) patients as per the licensed indication. This decision validates the medical contribution of Sibnayal® and its favorable cost/benefit ratio in treating dRTA.
In England, Advicenne has withdrawn its submission to the National Institute for Health and Care Excellence (NICE). The current absence of long-term outcome data for dRTA patients precluded a robust health economic model to be provided to NICE. Therefore, in England, Advicenne will work directly with specialist centers to make Sibnayal® available to treat dRTA patients.
Advicenne believes that the economic impact of this decision will be limited given the limited number of prescribers and hospitals requiring local access to Sibnayal®. In addition, Advicenne, within the framework of the European registry of patients suffering from dRTA, plans to collect data that will support a new submission to the NICE and provide the necessary long-term outcomes data.
Didier Laurens, Chief Executive Officer of Advicenne, commented: « We are very pleased with the availability of Sibnayal® to patients and caregivers in Great Britain. The Scottish decision validates the major therapeutic contribution of our drug and our economic vision for the product. Regarding NICE, we are confident that we will be able to meet their health-economic requirements in the future. Most importantly, patients and caregivers in Great Britain now have access to a drug which will benefit their daily lives. This announcement is a new step in Sibnayal®’s European business network, the aim is to maintain maximum value either via Advicenne as is the case in Great Britain or commercial partnerships.»
Sibnayal® ‘s availability for sale was announced in Great Britain in June 2022. Advicenne has set up the GB organization to support the commercial success of the product in terms of commercial, medical, and logistics.
Advicenne (Euronext: ALDVI) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal® (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/.
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.