Advicenne Updates on Availability of Sibnayal® to Patients and Caregivers in Great Britain
14 September 2022 - 07:00AM
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In England, Advicenne has withdrawn its submission to the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.
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®
(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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220913006243/en/
Advicenne Didier Laurens, CEO +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: barabian@ulysse-communication.com
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