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Advicenne Announces Significant Progress in Marketing Its Lead Product Sibnayal™ in Europe

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  • 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, December 07, 2021--(BUSINESS WIRE)--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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211206005860/en/

Contacts

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

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