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Advicenne announces significant progress in marketing its lead product Sibnayal™ in Europe | ||||||
By: GlobeNewswire - 07 Dec 2021 | Back to overview list |
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Advicenne announces significant progress in marketing its lead product Sibnayal™ in Europe
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 First distribution agreements signed covering 25% of European patients 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.”
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 TwinPharma CONTACTS
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 (Autorite? des marche?s 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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