• Sibnayal® (potassium citrate/potassium bicarbonate) has been launched on March 1, 2023
  • Reference price equals to an annual treatment cost of €15,000 per patient.

Regulatory News:

Advicenne (Euronext Growth Paris ALDVI - FR0013296746), a specialty pharmaceutical company dedicated to the development and commercialization of innovative treatments for those suffering from rare renal diseases, announces today the reimbursement of Sibnayal® (fixed combination of potassium citrate and potassium bicarbonate) in Denmark.

Advicenne and FrostPharma, partners for the Nordic and Baltic countries, have achieved a major success with the approved marketing of Sibnayal® as of March 1, 2023, by Danish pricing and reimbursement bodies. The Danish authorities recognize that the therapeutic contribution of Sibnayal® is commensurate to the severity of the disease in the absence of any treatment alternatives and justifies an annual cost of treatment close to 15,000 euros per patient.

Didier Laurens, Chief Executive Officer of Advicenne, declared: "I am particularly proud of this achievement for Advicenne and FrostPharma teams, who have done a remarkable job in educating and convincing the Danish health authorities. It is extremely gratifying they consider the value of Sibnayal® considering the severity of the disease and in the absence of any treatment alternatives. The Danish health authorities’ decision paves the way for the other European countries, currently under negotiation."

Fredrik Andersch, Chief Executive Officer of FrostPharma, declared: “We are very happy with our partnership with Advicenne and to have Sibnayal as a part of our portfolio. We are looking forward to making Sibnayal® available for children and adults suffering from rare renal diseases in the Nordic region. The decision from the Danish health authorities will significantly help these patients, their relatives and the healthcare.”

About Advicenne

Advicenne (Euronext: ALDVI) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal® (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU and GB. ADV7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US and in Canada. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022. For additional information see: https://advicenne.com/

About FrostPharma

FrostPharma is an entrepreneurial Swedish Specialty Pharma company specializing in the commercialization of value-adding medicines.

FrostPharma signed its first product distribution agreement in 2017, and since then 35 products have been added to the therapy agnostic portfolio through a strong agreement deal-flow, as well as through the development of proprietary products. The company has an established specialty pharma platform across the Nordics, and now actively plan to expand to additional EU countries. The FrostPharma portfolio of products are primarily oriented toward hospital use, and hospital initiation. FrostPharma has also developed a separate division offering sustainable solutions to petroleum based plastics across the Healthcare sector. https://frostpharma.com/

Disclaimer

This press release contains certain forward-looking statements concerning Advicenne group and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Advicenne considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the 2021 Universal Registration Document filed with the French financial market authority on April 29, 2022 (a copy of which is available on www.advicenne.com) and to the development of economic conditions, financial markets, and the markets in which Advicenne operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Advicenne or not currently considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Advicenne to be materially different from such forward-looking statements. Advicenne expressly declines any obligation to update such forward-looking statements.

Advicenne Didier Laurens, CEO +33 (0) 1 87 44 40 17 Email: investors@advicenne.com

Ulysse Communication Media relations Bruno Arabian +33 (0)6 87 88 47 26 Email: advicenne@ulysse-communication.com

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