Advicenne Gears Up for Accelerated Growth

Regulatory News:

Advicenne (Paris:ADVIC) (BSE:ADVIC)(Euronext: ADVIC) to provide an update on its ongoing activities and its management of the COVID-19 crisis during the company’s May 26 combined shareholders meeting, to take place behind closed doors as a consequence of the pandemic.

Advicenne demonstrated its resilience during the COVID-19 pandemic. Already accustomed to telecommuting prior to the crisis, the company has been able to pursue its activity with a minimum impact thanks to the commitment and dedication of its teams.

The year 2020 remains a pivotal year for Advicenne, which is gearing up to optimize its development and prepare market access for its lead drug candidate, ADV7103.

To this end, the company is gradually changing its governance with a concern for diversity of experience, knowledge, perspective and internationalization, through the successive appointments of:

• David Horn Solomon, appointed in December of 2019 in the context of a separation of the positions of Chief Executive Officer and Chairman of the Board, brings to the latter role extensive experience in the governance of listed pharmaceutical companies and value-creating industrial and financial agreements.
• Dr. André Ulmann, a nephrologist by training, who assumed the role of interim Chief Executive Officer in March of 2020 and who led his own company to success, is ideally placed to prepare Advicenne’s transition to market.
• Hege Hellstrom, recently appointed Independent Director, brings to Advicenne a wealth of recognized expertise in the development of nephrology products in Europe.

In Europe, a marketing application for ADV7103 in the treatment of distal renal tubular acidosis (dRTA) has been submitted to the European Medicines Agency (EMA). Review of the application proceeds as planned, with an anticipated positive opinion in this first indication at the end of 2020. The objective is to obtain European Union approval for the “distal tubulopathies” indication in early 2021. The commercial approach will be optimized on a territory-by-territory basis. In parallel, the pivotal Phase II/III CORAL clinical trial for ADVI7103 in the treatment of cystinuria continues.