Advicenne Completes European Commercial Coverage of Sibnayal® Through Its Agreement With Avanzanite Bioscience

28 Feb 2023 07:00 CET

• This new distribution agreement will cover Germany, Austria, Switzerland, and Greece.
• All European markets are now covered either directly or through partnerships.

Regulatory News:

Advicenne (Euronext Growth Paris ALDVI - FR0013296746) (Paris:ALDVI), a specialty pharmaceutical company dedicated to the development and commercialization of innovative treatments for those suffering from rare renal diseases, announced today that it has signed a distribution agreement with Avanzanite Bioscience B.V. ("Avanzanite") for the marketing of Sibnayal® (a fixed combination of potassium citrate and potassium bicarbonate) in Germany, the largest pharmaceutical market in Europe, Austria, Switzerland and Greece.

Under the terms of the agreement, Avanzanite is granted exclusive commercialization rights for Sibnayal® in its approved indication. Avanzanite will be responsible for conducting pricing and reimbursement negotiations with local regulatory authorities, as well as marketing and commercial activities. Advicenne will continue to hold the marketing authorization (MA) for Sibnayal® in the European Union. In Switzerland, Avanzanite will be responsible for filing the marketing authorization. In return, like with its existing agreements, Advicenne will receive the proceeds from the sale of Sibnayal® in the form of a transfer price and royalties.

With this agreement allowing Sibnayal® to be made available to German patients, Advicenne has completed its coverage of the five major European countries, either on its own or through partnerships. Sibnayal® is now being marketed throughout Europe which should significantly improve access to care for patients, and drive sales from 2023 onward.

Adam Plich, Founder and CEO of Avanzanite said: "The agreement with Advicenne perfectly illustrates our mission – both ethical and economic – to bring innovative medicines to rare disease patients in European markets no matter where they live.”

Didier Laurens, Chief Executive Officer of Advicenne, concluded: "We are very pleased to team with Avanzanite and its recognized expertise in rare diseases and market access. We are convinced that this partnership will enable us to make Sibnayal® available to the largest number of patients, particularly in Germany, the largest European pharmaceutical market. The completion of the coverage of the main markets in Europe is a major milestone in the further development of Advicenne and makes us extremely confident in the future of Sibnayal® and Advicenne.”

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 the UK. 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 Avanzanite Bioscience

Avanzanite is a pharmaceutical company on a mission to redefine the commercialization of orphan medicines to improve patient access across Europe and beyond. Derived from the word ‘Tanzanite’ – one of the rarest and most underappreciated gemstones on earth – Avanzanite was formed to capitalize on two primary objectives, one economic, and one humanitarian. The economic goal of Avanzanite is to offer end-to-end commercialization and distribution partnerships to research-based biopharmaceutical originators to unlock the full value of their orphan medicines in European markets. This is the unique expertise and core competency of the Avanzanite team through its decades of operating experience navigating this area. Equally important, the Company's humanitarian goal stems from the commitment to enabling access to novel medicines for patients who suffer from orphan diseases regardless of where in Europe they live. For more information: www.avanzanite.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.

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

Ulysse Communication
Media relations
Bruno Arabian
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Email: advicenne@ulysse-communication.com