PARIS & MILAN--(BUSINESS WIRE)--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, announces today it has entered (signed) an exclusive distribution partnership with SPA Società Prodotti Antibiotici (“SPA”), for the marketing of Sibnayal® (a fixed dose combination of potassium citrate and potassium bicarbonate) in Italy, Spain and Portugal.
Under the terms of the agreement, SPA is granted exclusive marketing rights to Sibnayal® in its current approved indication and potential new indications, in territories covering the South of Europe. SPA will be responsible for conducting pricing and reimbursement negotiations with local legal bodies, as well as marketing and commercial activities. Advicenne remains the Marketing Authorization Holder (MAH) of Sibnayal®. In return, Advicenne will receive the proceeds from the sale of Sibnayal® in the form of a transfer price and royalties for a combined amount significantly greater than 50% of future sales.
In addition to its already signed contracts, Advicenne deals with a strong local partner and continues to expand access to Sibnayal® as broadly as possible. Advicenne now covers commercially the following countries, either directly, or through partnerships: France, Great Britain, Italy, Spain, Portugal, Benelux, CEE, Nordics, Baltics, and the MENA region, which will significantly improve patient access and sales in the course of 2023.
Stefano Lombardi, Chief Executive Officer of SPA stated: “We are proud to partner with Advicenne and bring patients the Sibnayal® innovative approach to their rare condition treatment and improve their lives. The development of Sibnayal® in Italy, Spain, and Portugal, will be one of the gems of SPA Rare Diseases BU growth strategy projects.”
Didier Laurens, Chief Executive Officer of Advicenne, commented: “We are delighted with the signing of this agreement with SPA. Advicenne will benefit from the strong local presence of its new partner, its expertise, and the historic knowledge of Sibnayal®. This is a landmark agreement that will enable the development of Sibnayal® in Europe for the benefit of patients, families, and caregivers.”
SPA Società Prodotti Antibiotici is a private specialty pharmaceutical company founded in 1947.
The historical relevance of the brand is being one of the first to have manufactured and distributed Penicillin and other anti-infectives in Italy after WW II, with the direct partnership of Sir A. Fleming.
Owned by the third generation of the Founder, the Ferrari-Matta family, SPA products’ therapeutic areas today are Osteoarticular, Cardiometabolic, Urology, Nephrology and Gastroenterology. SPA’s growth strategy is based on the three strategic Business Units: SPA Farma (Ethical Drugs, OTC, Medical Devices), SPA Rare Diseases, BioSPA (In Vitro Diagnostics).
Headquartered in Milan, with affiliated companies SPA Farma Ibérica S.L. in Barcelona, Spain and Prospa Laboratoriòs Farmaceuticos S.A. in Lisbon, Portugal. For additional information see: https://spafarma.com/.
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/.
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.