PARIS–(BUSINESS WIRE)–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.
In the United States, the pivotal Phase II/III ARENA-2 clinical trial evaluating ADV7103 in the treatment of dRTA could not be pursued during the COVID-19 crisis, but is expected to resume in the fall with a simplified protocol. In order to optimize value creation in the United States, an American affiliate has been created and will be managed by Robbie McCarthy, an experienced pharmaceutical industry executive. His mission is to set up a local operational team, whose aim is to complete clinical study and proceed to the registration of ADV7103 as soon as possible.
“I have accompanied Advicenne since its creation as a director and then as an investor,” André Ulmann, Advicenne’s Chief Executive Officer, comments, “A few weeks of deep immersion in the company within teams totally committed to its success have confirmed my confidence in our ability to execute our market plan to deploy ADV7103. We have also begun to identify as yet untapped potential in terms of addressable markets. I am convinced that our impact can be significantly increased by optimizing actions and their costs according to patients’ priorities and needs. To this end, a territory-by-territory analysis is underway to optimize our commercial impact and risk-return profile. Our financial visibility is solid, allowing us to move forward and implement our plan.”
Advicenne (Euronext: ADVIC) is a pharmaceutical company specializing in the development and commercialization of innovative treatments in the field of nephrology. Our lead drug candidate, ADV7103, is currently in late-stage clinical trials for two renal indications, distal renal tubular acidosis (dRTA) and cystinuria, for both of which it has been granted orphan drug designation by the European Commission.
At Advicenne, our ambition is to deploy an innovative formulation in the development of new medicines that respond to unmet medical needs in the areas of nephrology and pediatrics.
Based in Paris, Advicenne has been listed on the Euronext Paris stock exchange since 2017 and was cross-listed on the Euronext Brussels stock exchange in 2019.
Forward-Looking Statements – Advicenne
This press release contains certain forward-looking statements which shall not be considered per se as historical facts. Such statements include projections and estimates, and the hypotheses on which these are based, as well as observations relating to operations, ongoing projects, objectives, the development of products and their future performance, and expectations regarding financial results.
In some cases, forward-looking statements can be identified by words such as “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” or similar words. Although the management of Advicenne believes that these forward-looking statements are reasonably made, investors should be aware that they are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. In particular, the expectations of Advicenne could be affected by, among other things, uncertainties involved in the placing on the market and commercialization of Advicenne products or any other risks and uncertainties developed or identified in any public documents filed by Advicenne with the French Financial Markets Authority (Autorité des marchés financiers (AMF)), including those listed in Chapter 4, “Risk Factors,” of its reference document, filed with the latter on December 19, 2019, under number D.19-1036. Advicenne disclaims any intention or obligation to publicly update or revise any forward-looking information and statements subject to applicable regulation, in particular article 223-1 and following of the General Regulation of the AMF.
Any information relating to the use of drug candidates contained in the present press release is based on the results of ongoing studies at the time of the release’s publication. A drug candidate is a product that has not yet received marketing authorization from a health agency.
David Solomon, André Ulmann &
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Dusan Oresansky & Emmanuel Huynh
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