- Changes in governance with the appointment of a new Chairman of the Board of Directors and a new Director
- Regrouping of all French Advicenne's teams in the new Paris headquarters to optimize resources
- Acceleration of the marketing of Sibnayal for the treatment of dRTA in several European territories
- Continuation of clinical development
Regulatory News:
Advicenne (Euronext Growth Paris ALDVI FR0013296746) (Paris:ALDVI), a pharmaceutical company specializing in the development and commercialization of innovative treatments for those suffering from rare renal diseases, today provides an update on the evolution of its governance as well as on its activities after its Annual General Meeting, which was held on June 9, 2022.
Changes in the Company's governance
The Combined Shareholders' Meeting held in Paris on June 9, 2022, adopted all the resolutions proposed for voting relating to the approval of the parent company and consolidated financial statements, the granting of financial delegations to the Board of Directors, as well as delegations and authorizations for the granting of stock warrants, bonus shares, and stock subscription or purchase options. The results of the vote by resolution are available on the Company's website in the Investors Medias section (https://advicenne.com/investors/).
The Combined General Meeting also appointed Mr. Didier Laurens as a director and Mr. André Ulmann as a non-voting director, for a three-year term.
The Board of Directors meeting held after this Meeting appointed as Chairman of the Board of Directors Mr. Philippe Boucheron, who will continue to serve as Chairman of the Remuneration Committee. The Board also noted the change in the permanent representative of Bpifrance Investissement, in the person of Mr. Thibaut Roulon who will also be member of the Audit Committee chaired by Mrs. Catherine Dunand.
The Board of Directors of Advicenne is now composed of the following members:
Philippe Boucheron, Director, Chairman of the Board
Mr. Didier Laurens, director, Chief Executive Officer
Cemag Invest, represented by Catherine Dunand, Director
Bpifrance Investissement, represented by Mr. Thibaut Roulon, Director
Irdi Soridec Gestion, represented by Mr. Jean-Michel Petit, director
Mrs. Charlotte Sibley, independent director
Mrs. Hege Hellstrom, independent director
-Mr. André Ulmann, observer.
The Combined General Meeting was an opportunity to present the progress of the Company's various programs and strategy.
Finalization of the Company's reorganization
Since March 2022, the Company has been in its new headquarters in Paris, where all French teams will move by the end of June. The historical offices in Nîmes will be closed, completing the reorganization begun last year. The new headquarters bring together all departments.
Advicenne now has a highly experienced and widely renewed management team to face the new challenges of the company, especially industrial and commercial, at a time when the company's business volume is growing.
Commercial development of licensed drugs
Advicenne markets several products in the field of neurology through distribution agreements. These products generated sales of approximately 2 million euros in 2021. The Company is pursuing the commercial development of these products and is exploring options that would allow it to increase, in particular, the value creation of Likozam, a formulation of clobazam in oral suspension.
In addition, the Company recalls that it has led the development of ADV6209 (Ozalin), which has had marketing authorization (MA) since 2018, for which the worldwide rights were transferred in 2016 to the Swiss laboratory Primex Pharmaceuticals AG; the product is distributed in the main European countries. Its commercial expansion should continue with the resumption post-Covid of scheduled surgical procedures in children as well as the upcoming opening of other European countries. Advicenne notes that the execution of the agreement is subject to the payment of royalties of a cumulative amount of 33 million euros by 2025, on top of the 7 million already received.
Continued commercial (Europe) and clinical development of Sibnayal
Following the granting of marketing authorization in Europe for Sibnayal, Advicenne is continuing its discussions with the health authorities with a view to setting the price and reimbursement conditions for the drug. The Company which has already signed several exclusive distribution partnerships covering Belgium, the Netherlands, Central and Eastern European countries and the Nordic countries, intends to make this treatment available in other European countries and other geographical areas soon.
Across the Atlantic, Advicenne is continuing its discussions with the FDA in order to optimize the clinical development of ADV7103 and is considering various partnership opportunities in order to give the product its full potential.
In addition, Advicenne is continuing to prepare clinical trials with a view to extending the indication of ADV7103 to cystinuria in both Europe and North America.
Didier Laurens, Chief Executive Officer of Advicenne, said: "Over the past few months, Advicenne has achieved several successes while shifting its center of gravity towards trade and controlling its expenses. We are now structured and fully dedicated to succeeding in market access and commercialization of our products. This is the case for Sibnayal, for which we have signed the first distribution partnerships in Europe, a trend that will intensify in the coming months, not only in the four major European markets (Germany, United Kingdom, France and Italy) but also outside the continent. The entire management team is aligned on a clear strategy: to maximize sales of these treatments in all European countries and beyond, and to ensure that ADV7103 has controlled clinical and regulatory development in North America. With four products already on the market, Advicenne is indeed an accomplished and quite unique biotech company."
About Advicenne
Advicenne (Euronext Growth Paris ALDVI FR0013296746) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product SibnayalTM (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU and the UK. ADV7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US and in Canada. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022. For additional information see: https://advicenne.com/.
Disclaimer
This press release contains certain forward-looking statements concerning Advicenne group and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Advicenne considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the 2021 Universal Registration Document filed with the French financial market authority on April 29, 2022 (a copy of which is available on www.advicenne.com) and to the development of economic conditions, financial markets and the markets in which Advicenne operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Advicenne or not currently considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Advicenne to be materially different from such forward-looking statements. Advicenne expressly declines any obligation to update such forward-looking statements.
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Contacts:
Advicenne
Didier Laurens, CEO
+33 (0)1 87 44 40 17
Email: investors@advicenne.com
Consilium Strategic Communications
Mary-Jane Elliott, Ashley Tapp, Davide Salvi
+44 (0)20 3709 5700
Email: advicenne@consilium-comms.com
Ulysse Communication
Media relations
Bruno Arabian
+33 (0)6 87 88 47 26
Email: barabian@ulysse-communication.com
