- 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™
Regulatory News:
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
patients Additionally, 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 Sibnayal™ 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 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. 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 TwinPharma TwinPharma 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 Orphan ExCEEd 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.
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/20211206005860/en/
Advicenne David Solomon, Chairman Didier Laurens, CEO +33
(0)4 66 05 54 20 investors@advicenne.com
Consilium Strategic Communications Mary-Jane Elliott,
Ashley Tapp, Davide Salvi +44 (0)20 3709 5700
advicenne@consilium-comms.com
Ulysse Communication Media relations Bruno Arabian +33
(0)6 87 88 47 26 advicenne@ulysse-communication.com