Advicenne announces positive opinion from the French Transparency Commission (HAS) for its drug SibnayalTM in dRTA
20 Dezember 2021 - 01:00PM
Advicenne
announces positive opinion from
the French Transparency
Commission (HAS) for its drug
SibnayalTM in dRTA
-
SibnayalTM eligible for
reimbursement by the French public
health insurance system
-
ASMR IV: Recognition
of the contribution of
SibnayalTM in
the treatment of dRTA
Paris, France,
20 December 2021
–
7:00
am CEST –
Advicenne (Euronext: ADVIC), a specialty pharmaceutical company
dedicated to developing and commercializing innovative treatments
for those suffering from rare renal diseases, announces is has
received a positive opinion from the French Transparency Commission
(HAS) with its lead asset, SibnayalTM eligible for reimbursement
with a Moderate Level SMR (Medical Rendered Service) and a Level IV
ASMR (Medical Rendered Service Improvement), in the treatment of
distal Renal Tubular Acidosis (dRTA) in adults, adolescents and
children over the age of 1.
This decision makes SibnayalTM the only
specialty pharmaceutical product reimbursed in the treatment of
dRTA in France, which will significantly ease access to treatment
of the disease for both patients and their doctors. The French
Transparency Commission (HAS – Haute Autorité de Santé), in its
opinion, acknowledges the contribution of the twice-daily dosing
formulation of SibnayalTM which significantly improves the quality
of life of patients as well as compliance to long-term treatment
plans. These factors contribute to the continuous improvement
of disease indicators, particularly bone mineral density, as shown
by the clinical development of SibnayalTM over a period of at least
4 years.
Didier Laurens, Chief
Executive Officer of Advicenne,
comments: “We are particularly pleased
and proud of the opinion delivered by the French Transparency
Commission. The reimbursement of SibnayalTM is a major step
forward for patients and their physicians. This opinion also
recognizes the benefit of a form of SibnayalTM that makes it easier
to administer with a positive impact on the long-term disease
indicators. This notice is an additional step towards the
commercialization of SibnayalTM, following the recent commercial
announcements.”
Distal renal tubular acidosis (dTRA) is an
orphan disease characterized by the inabilitý of the kidney to
excrete acids from metabolism. The excess of acids in the blood
leads to pH imbalance (acidosis) and multiple other complications:
growth retardation, bone development and rickets, metabolic
abnormalities (decreased blood potassium, elevated urinary
calcium), kidney stone formation, calcium deposits in the kidney
(calcinosis), renal failure. Whether genetic or acquired, as a
consequence of an immunological disease, ATRd is a chronic
pathology that affects approximately 30,000 patients in Europe and
20,000 in the United States.
About
Advicenne
Advicenne (Euronext: ADVIC) is a pharmaceutical
company founded in 2007, specializing in the development of
innovative treatments in Nephrology. Its lead drug candidate is
currently in late-stage clinical trials for two kidney diseases:
distal renal tubular acidosis and cystinuria. ADV7103 has just
received a positive CHMP opinion for the treatment of dRTA.
Headquartered in Paris, Advicenne has been listed on the Euronext
Paris stock exchange since 2017 and was cross listed on the
Euronext Brussels stock exchange in 2019. For additional
information see: https://advicenne.com/
CONTACTS
AdvicenneDidier Laurens, Chief Executive
Officer+33 (0)4 66 05 54 20Email: investors@advicenne.com |
Ulysses CommunicationMedia
relationsBruno Arabian+33 (0)6 87 88 47 26Email:
advicenne@ulysse-communication.com |
Consilium Strategic CommunicationsMary-Jane
Elliott, Ashley Tapp, Davide Salvi+44 (0)20 3709 5700Email:
advicenne@consilium-comms.com |
|
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Advicenne,
which shall not be considered per se as historical facts. Such
statements include projections and estimates, and the hypotheses on
which these are based, as well as observations relating to
operations, ongoing projects, objectives, the development of
products and their future performance, and expectations regarding
financial results.
In some cases, forward-looking statements can be
identified by words such as "could," "should," "may," "expects,"
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"targets" or similar words. Although the management of Advicenne
believes that these forward-looking statements are reasonably made,
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known and unknown risks and uncertainties and other factors that
may cause actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by these forward-looking
statements. In particular, the expectations of Advicenne could be
affected by, among other things, uncertainties involved in the
placing on the market and commercialization of Advicenne products
or any other risks and uncertainties developed or identified in any
public documents filed by Advicenne with the French Financial
Markets Authority (Autorité des marchés financiers (AMF)),
including those listed in Chapter 4, “Risk Factors,” of its
universal registration document, filed with the latter on December
22, 2020. Notwithstanding the compliance with article 223-1 of the
General Regulation of the AMF (the information disclosed must be
“accurate, precise and fairly presented”), Advicenne disclaims any
intention or obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.