Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal) and announces Leadership Changes to support Commercialisation

Regulatory News:

Advicenne (Euronext: ADVIC) (Paris:ADVIC) (BSE:ADVIC), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases, is pleased to announce that the European Commission (EC) has granted marketing authorisation to ADV7103 (Sibnayal), for the treatment of distal renal tubular acidosis (dRTA).

This approval makes ADV7103 the first and only label-approved drug for the treatment of dRTA in adults, adolescents and children aged one year and older. With the approval, Advicenne has the opportunity to make a significant difference to patients suffering from dRTA, classified as an orphan condition affecting no more than 1 to 2 individuals per 10,000 people in Europe.

The EC marketing authorisation will be valid in all EU Member States, in the United Kingdom as well as in the European Economic Area (EEA) countries (Iceland, Liechtenstein and Norway).

Dr. David Horn Solomon, Chairman at Advicenne, commented: “We are delighted for the approval of ADV7103 by the European Commission. Advicenne will now focus on making the product available to patients as rapidly as possible. This approval marks a major milestone for the Company as it endeavours to bring to market therapeutics in areas of high unmet need. Kidney diseases are the 10^th leading cause of mortality in the world which highlights the urgent need to develop innovative therapies for severe renal rare diseases.”

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.

In addition to the approval of ADV7103 by the European Commission, Advicenne announces today several changes in governance and in its senior leadership team. Peter Meeus is leaving his position as Chief Executive Officer for personal reasons with immediate effect. In his place, the Board has appointed Mr Didier Laurens. Mr Laurens is a highly experienced executive who is currently serving as Chief Financial Officer of surgical robotics company eCential Robotics. Prior to this, he served as Chief Financial Officer for Pixium Vision and as Investor Relations, Treasury and Financing Director for Korian, a company specialized in care for the elderly. Advicenne’s Chairman David Solomon will also assume an expanded role including new reponsibilities to ensure a smooth transition of CEO duties from Peter to Didier.