Advicenne Expects Imminent Marketing Authorization for ADV7103 (Sibnayal) for dRTA in Europe

Regulatory News:

Advicenne (Euronext: ADVIC) (Paris:ADVIC) (BSE:ADVIC) (the “Company”), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for rare renal diseases, announced that it anticipates imminent European Marketing Authorization for its lead product, ADV7103 (Sibnayal). Concurrently, and in order to prevent any delays to the potential patient availability of the product, the Company has decided to withdraw its application for the Orphan Drug Designation (ODD), as it was informed by EMA that additional data would be needed to grant /confirm ODD status.

As such, Advicenne will be able to make ADV7103 available to patients suffering from dRTA in Europe in the shortest possible timeframe. In Europe, dRTA is classified as an orphan condition affecting less than 2.1 per 10,000 people. The approval will make ADV7103 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. Given the debilitating consequences of the condition, the Company is convinced that with ADV7103 it has the opportunity to make a significant difference to patients sufferering from dRTA.

ADV7103 is developed as a multi-particulate formulation in 2mm granules, a novel pioneering delivery technology created by Advicenne that contains two active pharmaceutical ingredients. This approach not only has led to an excellent effectiveness in controlling metabolic acidosis, but also to ease the administration and aid compliance and quality of life in patients of all ages.

Peter Meeus, Chief Executive Officer of Advicenne, said: ”We are focused on bringing our treatments to patients as expediously as possibly and are delighted about the near-term prospects for Sibnayal. This could bring life-changing benefits to patients with dRTA and we are excited to advance our medicine.”

About dRTA
Distal renal tubular acidosis dRTA is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (nephrocalcinosis) as well as possible kidney failure.