PARIS--(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, updates today the progress of the partnerships signed during 2022 in Europe and the Middle East for the marketing of Sibnayal® (a fixed dose combination of potassium citrate and potassium bicarbonate).
Significant achievements in Nordic countries
Advicenne and its partner for the Nordic and the Baltic countries, Frost Pharma, have recently achieved their first major successes, where in Norway physicians can now prescribe Sibnayal® with an official price since 1st February.
In Sweden, TLV (Tandvårds- och LäkemedelsförmånsVerket), the drug management agency, has just rejected the application for national reimbursement and leave Swedish hospitals to finance the product on their own budget. Patients already on Sibnayal via the temporary access program, will now need to be transferred to hospital paid treatment, as well as new patients switched to Sibnayal from other therapies.
Significant progress in other countries
In other European countries, Advicenne's commercial partners are also making significant progress. In Belgium, Twin Pharma has obtained a price and is now in the process of getting reimbursement for Sibnayal.
In Central and Eastern Europe, ExCEEd Orphan is focusing primarily on setting up early access programs and with the first patients included in Croatia, the Czech Republic, Slovakia, and Bulgaria.
The strategy is similar for Taïba Healthcare in the Middle East, where early access programs are being set up to establish initial market access. At the same time, Taïba Healthcare and Advicenne are preparing to file a registration application in Saudi Arabia and United Arab Emirates.
Didier Laurens, CEO of Advicenne, stated: "We are delighted with the progress of our commercial partnerships, the progress made, and the results achieved. They are in line with our expectations. Signing off these partnerships is paying off and we anticipate significant successes soon. However, we know that the road to market is fraught with regulatory hurdles. The contrast of decisions, based on the same documents and scientific results, illustrates the difficulties faced by Advicenne, like any other pharmaceutical company, in pricing and reimbursement negotiations. It is all the more difficult to understand that the European authorities are pushing for the specific development of adapted formulations for pediatric patients and at the same time some authorities do not recognize the development work done; and rare diseases may deserve a specific and adapted financing model of drugs. In Germany, several patients treated with Sibnayal® are already covered directly by their private insurance. Despite obstacles, long-term follow-up results will make it possible to assess the value of Sibnayal® and the justification for its coverage. For the time being, Sibnayal® enjoys strong support from specialist doctors and expert centers. Today, more than 150 patients are treated in Europe and their testimonies confirm our optimism in the success of our development.”
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® (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 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/.
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.