ADVIC Advicenne SA

Advicenne to Present Additional Data on ADV7103 at the European Society for Paediatric Nephrology During Its 51st Annual Meeting

Regulatory News:

Advicenne (Paris:ADVIC), a specialist pharmaceutical company focused on the development of pediatric-friendly therapeutics for the treatment of orphan renal and neurological diseases, announces today that the company strengthens its scientific relationship with the European Society for Paediatric Nephrology (ESPN) during the 51st Annual Meeting which is being held October 3-8, 2018, in Antalya, Turkey. The relationship now accelerates with the active execution phase of the partnership announced on May 15th, 2018.

Advicenne’s management is participating as a partner of the Annual Meeting and held a Symposium on October 4th, chaired by Elena Levtchenko. The company presents additional supporting data for ADV7103 in a poster “Assessment of Urine Parameters After Administration of ADV7103 in Healthy Adults and dRTA Patients” and can be found .

The Advicenne Symposium, chaired by Dr Levtchenko is dedicated to “dRTA, toward a better management”. This symposium has given the opportunity to Fernando Santos (Oviedo, Spain) to share his clinician concerns about the transition period between childhood and adulthood for dRTA patients. Pr Detlef Bockenhauer (London, UK) presented the ESPN/ERKNet registry and Pierre Cochat (Lyon, France) presented the latest update on ADV7103 clinical program.

Dr. Luc-André Granier, co-founder, Chief Executive Officer and Medical Director of Advicenne comments “dRTA is a rare and devastating nephrological condition that can alter organ function, soften bones and affect the cardiovascular system, and for which there are currently no approved treatments. We remain committed to the continued development of this important program, including the initiation of the ARENA-2, pivotal phase III trial of ADV7103 in children and adults, for which the U.S. Food & Drug Administration cleared IND status on September 5th, 2018.”

About the European Society for Paediatric Nephrology

The European Society for Paediatric Nephrology () is a medical society organization that aims to promote research knowledge of paediatric nephrology through teaching, scientific meetings and other methods, for the benefit of children with renal disease. Advicenne is a sponsor of this year’s Annual Meeting.

About distal Renal Tubular Acidosis (dRTA)

dRTA is a disease that occurs when the kidneys do not properly remove acids from blood into urine. As a result, acid overload generates an unbalanced blood pH that trigger failure to thrive and rickets (a condition that affects bone development in children) as well as a range of additional clinical disorders such as a potassium deficiency (hypokalaemia) in blood serum, thus altering the function of several organs and most prominently affecting the cardiovascular system. In addition, a high concentration of calcium in blood and urine (hypercalcemia and hypercalciuria, respectively) can lead to kidney stones and calcinosis which may potentially cause renal impairment and ultimately renal failure. Either genetic or acquired as a result of autoimmune disease, dRTA is estimated to affect 30 000 patients in Europe and 20 000 in the US.

About Advicenne

Advicenne (Euronext: ADVIC) specializes in pediatric-friendly therapeutics for the treatment of orphan renal and neurological diseases. The French pharmaceutical company’s lead product, ADV7103, has achieved positive results in Europe in a pivotal phase III study in children and adults with distal Renal Tubular Acidosis (dRTA). In addition to this indication, ADV7103 is being developed for Cystinuria, an inherited renal tubulopathy.

Advicenne plans to file ADV7103 for European market authorization for dRTA in the second half of 2018 and anticipates its commercial launch in 2020. In the United States, the FDA has cleared ADV7103’s Investigational New Drug (IND) application to initiate a pivotal phase III clinical trial assessing the drug in dRTA patients. Commercial launch in the United States is anticipated for 2021.

Advicenne is listed on the regulated market of Euronext in Paris (ISIN: FR0013296746; Euronext ticker: ADVIC). Established in 2007, the company is headquartered in Nîmes, France.

EN
04/10/2018

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Advicenne SA

 PRESS RELEASE

Advicenne franchit une étape importante avec la FDA américaine dans le...

PARIS--(BUSINESS WIRE)-- Regulatory News: Advicenne (Euronext Growth Paris ALDVI - FR0013296746), société pharmaceutique spécialisée dans le développement et la commercialisation de traitements innovants pour les personnes souffrant de maladies rénales rares, fait le point sur les récents échanges avec la FDA (Food and Drug Administration) sur le développement de ADV7103 dans la cystinurie aux Etats-Unis et annonce avoir franchi une étape clé. Comme annoncé, la société a entamé un nouveau cycle d’échanges avec la FDA dans le but de finaliser le plan de développement de ADV7103 dans la cyst...

 PRESS RELEASE

Advicenne annonce ses ventes brutes 20241

PARIS--(BUSINESS WIRE)-- Regulatory News: Advicenne (Euronext Growth Paris ALDVI - FR0013296746), société pharmaceutique spécialisée dans le développement et la commercialisation de traitements innovants pour les personnes souffrant de maladies rénales rares, annonce aujourd’hui que ses ventes brutes ont atteint 4,8 millions d’euros pour l’exercice 2024, en hausse de 9,2% par rapport à l’exercice précédent. Les ventes brutes n’intègrent pas les royalties des partenaires sur les ventes réalisées dans leurs territoires respectifs, estimées à 0,5 million d’euros pour 2024. La croissance des v...

 PRESS RELEASE

Advicenne finalise un accord avec Primex Pharmaceuticals AG

PARIS--(BUSINESS WIRE)-- Regulatory News: Advicenne (Euronext Growth Paris ALDVI - FR0013296746), société pharmaceutique spécialisée dans le développement et la commercialisation de traitements innovants pour les personnes souffrant de maladies rénales rares, annonce aujourd’hui la conclusion d’un accord avec Primex Pharmaceuticals AG, société biopharmaceutique suisse. Cet accord finalise la restructuration des contrats signés en 2016. Dans ce cadre, Advicenne percevra 3,5 millions d’euros, dont la moitié au cours de l’exercice 2024 et le solde au cours des 18 prochains mois. Advicenne est é...

 PRESS RELEASE

Advicenne annonce son calendrier financier 2025

PARIS--(BUSINESS WIRE)-- Regulatory News: Advicenne (Euronext Growth Paris ALDVI - FR0013296746), société pharmaceutique spécialisée dans le développement et la commercialisation de traitements innovants pour les personnes souffrant de maladies rénales rares, annonce son calendrier de communication financière 2025. Evènement Date* Publication des ventes 2024 23 janvier 2025 Publication des résultats annuels 2024 27 mars 2025 Assemblée Générale des Actionnaires 15 mai 2025 Publication des résultats semestriels 2025 18 septembre...

 PRESS RELEASE

Advicenne franchit des étapes majeures aux Etats-Unis grâce à plusieur...

PARIS--(BUSINESS WIRE)-- Regulatory News: Advicenne (Euronext Growth Paris ALDVI - FR0013296746), société pharmaceutique spécialisée dans le développement et la commercialisation de traitements innovants pour les personnes souffrant de maladies rénales rares, annonce aujourd’hui le franchissement d’étapes majeures dans le programme de développement de son médicament ADV7103 aux Etats-Unis et la recherche de partenaires commerciaux. ADV7103 dans l’ATRd (Acidose Tubulaire Rénale distale) : les données européennes sont jugées satisfaisantes par la FDA pour un dépôt d’AMM sans étude clinique add...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch