ADV7103 becomes the first and only
label-approved drug for the treatment of distal renal tubular
acidosis (dRTA) in adults, adolescents and children aged one year
and older
Didier Laurens to join Advicenne as new CEO
Resumption of trading at the opening of the
stock market on 4 May 2021
Regulatory News:
Advicenne (Euronext: ADVIC) (Paris:ADVIC) (BSE:ADVIC), a
specialty pharmaceutical company dedicated to developing and
commercializing innovative treatments for those suffering from rare
renal diseases, is pleased to announce that the European Commission
(EC) has granted marketing authorisation to ADV7103 (Sibnayal™),
for the treatment of distal renal tubular acidosis (dRTA).
This approval makes ADV7103 the first and only label-approved
drug for the treatment of dRTA in adults, adolescents and children
aged one year and older. With the approval, Advicenne has the
opportunity to make a significant difference to patients suffering
from dRTA, classified as an orphan condition affecting no more than
1 to 2 individuals per 10,000 people in Europe.
The EC marketing authorisation will be valid in all EU Member
States, in the United Kingdom as well as in the European Economic
Area (EEA) countries (Iceland, Liechtenstein and Norway).
Dr. David Horn Solomon, Chairman at Advicenne, commented:
“We are delighted for the approval of ADV7103 by the European
Commission. Advicenne will now focus on making the product
available to patients as rapidly as possible. This approval marks a
major milestone for the Company as it endeavours to bring to market
therapeutics in areas of high unmet need. Kidney diseases are the
10th leading cause of mortality in the world which highlights the
urgent need to develop innovative therapies for severe renal rare
diseases.”
ADV7103 is developed as a multi-particulate formulation in 2mm
granules, a novel pioneering delivery technology created by
Advicenne that contains two active pharmaceutical ingredients. This
approach not only has led to an excellent effectiveness in
controlling metabolic acidosis, but also to ease the administration
and aid compliance and quality of life in patients of all ages.
In addition to the approval of ADV7103 by the European
Commission, Advicenne announces today several changes in governance
and in its senior leadership team. Peter Meeus is leaving his
position as Chief Executive Officer for personal reasons with
immediate effect. In his place, the Board has appointed Mr Didier
Laurens. Mr Laurens is a highly experienced executive who is
currently serving as Chief Financial Officer of surgical robotics
company eCential Robotics. Prior to this, he served as Chief
Financial Officer for Pixium Vision and as Investor Relations,
Treasury and Financing Director for Korian, a company specialized
in care for the elderly. Advicenne’s Chairman David Solomon will
also assume an expanded role including new reponsibilities to
ensure a smooth transition of CEO duties from Peter to Didier.
Dr. David Horn Solomon, Chairman at Advicenne, concluded:
“A new phase has started for Advicenne with the approval of our
lead candidate, ADV7103, by the European Commission. My thanks go
to Peter for his hard work over the past few months and for helping
us achieve this outstanding result. I am also delighted to welcome
Didier to Advicenne: his experience will no doubt enable us to
progress our trials for ADV7103 for cystinuria in Europe and dRTA
and cystinuria the US, to the benefit of an increasing number of
patients affected by rare renal conditions.”
The company has requested that Euronext suspend the listing of
its shares during the trading session of 3 May 2021. The Advicenne
share will resume trading at the opening of the stock market on 4
May 2021, following the publication of this press release.
About dRTA
Distal renal tubular acidosis (dRTA) is an orphan disease
characterized by a failure in the renal excretion of acids
generated through metabolism and for which there is no approved
treatment. The excess of acids thus accumulated in the blood leads
to an imbalance in pH (acidosis) as well as multiple other
complications such as growth retardation and rickets (a disease
affecting bone development) in children, and a series of metabolic
disorders such as low potassium levels, elevated calcium in the
urine resulting in kidney stones, the formation of calcium deposits
in the kidneys (calcinosis) as well as possible kidney failure.
Whether genetic or acquired as a consequence of an immune
disease, dRTA affects an estimated 30,000 patients in Europe and
approximately 20,000 in the United States.
About the Phase III European program in dRTA (B21CS pivotal
study & B22CS extension study)
B21CS was a multicenter pivotal study that enrolled 37 patients
suffering from dRTA, including adults, adolescents, children and
infants and aimed to assess the efficacy of ADV7103 compared to
Standard of Care (SoC) on blood and urine biomarkers of metabolic
acidosis. Patients took the SoC treatment for five consecutive days
followed by five days of two daily doses of ADV7103, an innovative
prolonged-release granule combination of potassium citrate and
potassium bicarbonate. Based on the blood and urine parameters, the
study results demonstrated the effectiveness and suggested clinical
benefit of ADV7103 in dRTA patients in comparison with the SoC. The
B22CS extension study was an open-label clinical study that
confirmed the efficacy and safety of ADV7103 after 24 months of
treatment. ADV7103 has successfully met the primary and secondary
endpoints of the study and demonstrated its ability to treat
biological disorders caused by dRTA.
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/
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," "anticipates,"
"believes," "intends," "estimates," "aims," "targets" or similar
words. Although the management of Advicenne believes that these
forward-looking statements are reasonably made, investors should be
aware that they are subject to a number of 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210503005562/en/
Advicenne David Solomon, Président +33 (0)4 66 05 54 20
Email: investors@advicenne.com
Ulysse Communication Bruno Arabian +33 (0)1 42 68 29 70
Email: barabian@ulysse-communication.com
NewCap Financial communications Dusan Oresansky, Emmanuel
Huynh +33 (0)1 44 71 94 94
Media relations Nicolas Merigeau +33 (0)1 44 71 94 98
Email: advicenne@newcap.eu
Consilium Strategic Comminications Mary-Jane Elliott,
Ashley Tapp, Davide Salvi +44 (0)20 3709 5700 Email:
advicenne@consilium-comms.com