PARIS--(BUSINESS WIRE)--Regulatory News:
Advicenne (Paris:ADVIC) (BSE:ADVIC) (Euronext: ADVIC), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases, provides an update on its activities following its Annual General Meeting, which was held virtually on June 14, 2021.
During the Annual General Meeting, a majority of shareholders voted for all resolutions as recommended by the Board of Directors. 4,379,697 shares were represented in voting, corresponding to 50,88% of the Company’s 8,607,568 shares. The full results of the AGM are posted on the Company’s website and can be found at the following link: https://advicenne.com/investors/.
Over the course of the AGM, attendees were introduced to Advicenne 2.0, the Company’s new strategy to maximize value creation for shareholders, details of which can be found below.
Advicenne 2.0: a clear strategic pathway
Advicenne aims to capitalize on the recent EU marketing authorization (MA) for Sibnayal™ (ADV7103) in distal Renal Tubular Acidosis (dRTA), expanding approved use both geographically and therapeutically, with strict financial discipline and capital allocation, and backed by a strong and highly experienced management team.
The first priority as part of the Advicenne 2.0 strategy is to complete a partnership in Europe to generate commercial sales of Sibnayal™ in dRTA following its marketing authorization by the European Medicines Agency (EMA). The company is identifying the appropriate partners to maximize market potential in the main European markets and provide its shareholders with the highest return.
The second priority is to accelerate the clinical development of Sibnayal™ in the US in two indications: dRTA and cystinuria. Advicenne has recently received positive feedback from the US Food and Drug Administration (FDA) on an amended Phase III study protocol and on a pathway to approval for Sibnayal™ for the treatment of dRTA. This will enable Advicenne to resume before the summer its Phase III clinical trial, ARENA 2, in the US. The right resources will be allocated to run the US development program in accordance with the FDA requirements and anticipate a potential first marketing authorization in the US before the end of 2022. The first approval of Sibnayal™ in the US would be a major milestone for the Company and a significant value driver for shareholders.
In parallel, the Company is pursuing the clinical development of Sibnayal™ in cystinuria both in Europe and in the US, with a potential approval in first-half 2023 and second-half 2023, respectively. Sibnayal™ is now a largely de-risked medicine following its approval by the European Commission and the clearance of its clinical development in the US in dRTA.
The decision to prioritize capital allocation to Sibnayal™ is largely driven by its favorable risk / reward profile and its peak sales potential. The resources to progress the US development of Sibnayal™ and unlock shareholder value will partly come through a partnership to ensure Sibnayal™’s commercial success in Europe as well as from the license agreement on Ozalin® with Primex.
Strengthened management to lead Advicenne 2.0
With a clear new strategy and corporate goals in place, Advicenne has implemented major changes in management to align the executive team with the Company’s ambitions. The Chairman of the Board, David Solomon, is taking an expanded executive role alongside the newly appointed Chief Executive Officer, Didier Laurens. A highly recognized industry executive, Didier brings his experience in finance and investor communications, combined with his 10-year background in marketing in the pharmaceutical industry. Robbie MacCarthy joined as General Manager of Advicenne’s US subsidiary bringing extensive knowledge of the US market, clinical development, and years of experience in rare diseases and start-up organizations. He has already hired an experienced team that is committed to restart and progress ARENA-2.
Advicenne will continue to strengthen its management team by hiring highly experienced executives in medical affairs, manufacturing, and commercial operations in the near term.
Our lead product, Sibnayal™, is ready to launch and the Company is committed to fully unlock the value of its lead product both in dRTA and Cystinuria and both in Europe and North America to the benefit of our shareholders. Advicenne 2.0 marks a new era for patients and shareholders.
Advicenne (Euronext: ADVIC) is a pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead drug candidate is currently in late-stage clinical trials for two kidney diseases: distal renal tubular acidosis and cystinuria. ADV7103 has just received a Marketing Approval (MAA) for the treatment of dRTA. Headquartered 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.
For additional information see: https://advicenne.com/
This press release contains certain forward-looking statements relating to the business of Advicenne, which shall not be considered per se as historical facts. Such statements include projections and estimates, and the 3/3 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 "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets" 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 universal registration document, filed with the latter on December 22, 2020. Notwithstanding the compliance with article 223-1 of the General Regulation of the AMF (the information disclosed must be “accurate, precise and fairly presented”), Advicenne disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.