Advicenne 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.
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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.