In 2017, ADV7103 was granted orphan drug designation by the European Commission in the treatment of distal renal tubular acidosis (dRTA), a rare kidney disorder that occurs when the kidneys are unable to effectively remove the buildup of circulating acids in the blood. Currently in Phase III clinical trials for this indication in Europe, the United States and Canada, ADV7103 was submitted for European marketing authorization in March of 2019. If approved, it will be the first authorized treatment for dRTA.
While we prepare its European commercial launch for dRTA, we are simultaneously conducting trials for ADV7103 in the treatment of cystinuria, a genetic disease characterized by cystine stones in the kidneys and bladder.
ADV7103’s Phase II/III European clinical trials for cystinuria were recently expanded to Belgium.
Headquartered in Nîmes, France, Advicenne was listed on the Euronext Paris stock exchange in December 2017 (ADVIC – FR0013296746). In June 2019, shares of our company began trading on the Euronext Brussels, giving Advicenne cross-listed status on the two largest Euronext life sciences markets.
At Advicenne, we are committed to innovating in the areas of formulation and clinical development. Tasteless and easy to administer, ADV7103 will be commercialized in small-size formats that offer flexible, personalized dosing – because pathbreaking treatments for rare diseases should be available to patients of all ages.
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Het bedrijf specialiseert zich in zeldzame nierziektes. Genoteerd in Parijs en Brussel.
- First round of pricing negotiations completed in the United Kingdom
- TwinPharma and ExCEEd Orphan to commercialize Sibnayal™ in Benelux and Central and Eastern
European Countries respectively, covering 25% of all patients affected by dRTA
- Advicenne will receive a combination of transfer price and royalties for an amount markedly higher than 50% of future sales of Sibnayal™
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
Advicenne announces today that it has achieved a first marketing milestone in the UK, having obtained from the NHS (National Health Service) prices of £120 and £360 respectively for its 8Meq and its 24Meq dosages. This corresponds to an average annual treatment price for dRTA patients above 10,000 euros, in line with Advicenne’s expectations. Advicenne is now in discussions with the National Institute for Health and Care Excellence (NICE) for the coverage and reimbursement of its treatment. The Medicines & Healthcare products Regulatory Agency (MHRA) recently granted marketing authorisation for Sibnayal™ in the UK.
First distribution agreements signed covering 25% of European patients
Additionally, Advicenne has signed its first two exclusive distribution agreements for Sibnayal™
in the European Union. The Company has signed an exclusive partnership with specialty pharmaceutical company TwinPharma in Benelux (Belgium, the Netherlands, and Luxembourg) and with ExCEEd Orphan, a Czech business solution provider for biotechnology and pharmaceutical companies, in Central and Eastern European Countries. 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