Advicenne announces significant progress in
marketing its lead product Sibnayal™ in
Europe
- First round of pricing negotiations completed in the United
Kingdom
- TwinPharma and ExCEEd Orphan to commercialize Sibnayal™ in
Benelux and Central and Eastern European Countries respectively,
covering 25% of all patients affected by dRTA
- Advicenne will receive a combination of transfer price and
royalties for an amount markedly higher than 50% of future sales of
Sibnayal™
Paris, France, 7 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, is pleased
to announce that it has made significant progress in the marketing
and distribution of ADV7103 (Sibnayal™), 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. The Company has completed the first round of
pricing negotiations in the United Kingdom (UK) and has signed its
first two distribution agreements for Sibnayal™, which covers 25%
of European patients affected by the disease.
Significant market access advances in the
United Kingdom Advicenne announces today that it has achieved a
first marketing milestone in the UK, having obtained from the NHS
(National Health Service) prices of £120 and £360 respectively for
its 8Meq and its 24Meq dosages. This corresponds to an average
annual treatment price for dRTA patients above 10,000 euros, in
line with Advicenne’s expectations. Advicenne is now in discussions
with the National Institute for Health and Care Excellence (NICE)
for the coverage and reimbursement of its treatment. The Medicines
& Healthcare products Regulatory Agency (MHRA) recently granted
marketing authorisation for Sibnayal™ in the UK.
First distribution agreements signed covering
25% of European patientsAdditionally, Advicenne has signed its
first two exclusive distribution agreements for Sibnayal™ in the
European Union. The Company has signed an exclusive partnership
with specialty pharmaceutical company TwinPharma in Benelux
(Belgium, the Netherlands, and Luxembourg) and with ExCEEd Orphan,
a Czech business solution provider for biotechnology and
pharmaceutical companies, in Central and Eastern European
Countries.
Under the terms of these agreements, TwinPharma
and ExCEEd Orphan will receive exclusive marketing rights to
Sibnayal™ for the treatment of dRTA in their respective markets,
which cover 25% of European patients. For its part, Advicenne will
receive a transfer price for the sale of its product and royalties
for an amount significantly higher than 50% of future sales.
Earlier this year, the European Commission
granted marketing authorisation to Sibnayal™ for the treatment of
dRTA).
Didier Laurens, Chief Executive Officer of
Advicenne, comment: “We are pleased to have accomplished these
first marketing and distribution milestones in the UK and the EU
which are key in Sibnayal’s commercial journey. The NHS is setting
a benchmark price which highlights the benefit of SibnayalTM in
offering a new therapeutic option which improves the quality of
life of patients suffering from dRTA. We are also delighted to have
signed collaboration agreements with TwinPharma for Benelux and
ExCEEd Orphan for Central & Eastern Europe – two of the most
successful rare disease specialists. These agreements will make
Sibnayal™ available to about 25% of the 30,000 European dRTA
patients and we are pleased and honored to make this treatment
available as quickly as possible.
Gert van Alewijk, Managing Partner of
TwinPharma stated: “We are delighted to announce this close
cooperation with Advicenne. Distal Renal Tubular Acidosis (dRTA) is
a rare type of kidney disease that can have a have major impact on
a person’s health throughout their life. By introducing Sibnayal™,
prescribers have the possibility to improve the lives of patients
suffering from dRTA.”
Jiri Hermanek, Chief Executive Officer and
Founding Partner of ExCEEd Orphan commented: “I personally, and
all my colleagues are very pleased to announce this collaboration
to make Sibnayal™ available to patients suffering from dRTA across
Central and Eastern European countries. This unique medicine is the
only treatment alternative approved by the EMA for the treatment of
dRTA and as such brings hope to all patients and their relatives.
Sibnayal™ represents an important addition to the continuously
growing portfolio of rare disease medications marketed and
distributed by ExCEEd Orphan. We are fully committed to bring this
unique medication to all patients in needs in all respective
countries of CEE region.”
About Advicenne
Advicenne
(Euronext: ADVIC) is a specialty pharmaceutical company founded in
2007, specializing in the development of innovative treatments in
Nephrology. Its lead product SibnayalTM (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. 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/.
About TwinPharmaTwinPharma is specialized
in the sales, marketing, and distribution of specialty
pharmaceuticals in the Netherlands, Belgium, and Luxembourg.
TwinPharma contributes to the improvement of pharmaceutical care in
the Benelux by introducing value-added medicines that were
previously not available in these countries. By forming a strategic
alliance with FrostPharma of Sweden and ExCEEd Orphan (Czech
Republic), the group can target more than 180 million Europeans in
25 countries. The founders, Gert van Alewijk and Bauke Buwalda,
joined forces in TwinPharma in 2006. www.twinpharma.com About
ExCEEd OrphanExCEEd Orphan was founded in 2018 by five rare
disease experts from multiple Central and Eastern European (CEE)
countries. The Company is focusing on innovative treatments for
rare diseases and has extensive experience in launching innovative
medicines in this field. The portfolio of ExCEEd Orphan
includes products in therapeutic areas like haematology, neurology,
immunology, and metabolic diseases. For further information about
ExCEEd Orphan, please visit www.exceedorphan.com
CONTACTS
Advicenne David Solomon, ChairmanDidier Laurens, CEO+33 (0)4
66 05 54 20Email: investors@advicenne.com |
Ulysse 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 |
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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
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In some cases, forward-looking statements can be
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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.