NÎMES, France--(BUSINESS WIRE)--Regulatory News:
Advicenne (Euronext:ADVIC), a specialty pharmaceutical company focused on the development of pediatric friendly therapeutics for the treatment of orphan renal and neurological diseases, announced today that it has been awarded the prestigious 2018 Prix Galien - Medstartup Award for Best Innovative Trial Design for ADV7103. The award was presented at a ceremony in New York City on October 25, 2018.
Advicenne received clearance from the U.S. Food and Drug Administration and Health Canada to initiate its ARENA-2 pivotal Phase III trial for the treatment of dRTA in early September and October 2018, respectively.
“This recognition by the Galien Foundation and Business France is an exceptional honor for Advicenne as it underscores the importance of our approach to bring a critically needed therapy to the market for this underserved and debilitating orphan disease,” said Luc-André Granier, Chief Executive Officer of Advicenne. “We plan to file a market authorization dossier in Europe in the next coming months and look forward to moving ahead with this important North American trial.”
About ARENA-2
ARENA-2 is a pivotal Phase III, prospective, multicenter, randomized, double-blind, placebo-controlled study expected to enroll approximately 40 patients in the United States and Canada. The primary objective of the study is to evaluate the safety and efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis defined by serum bicarbonate level in pediatric (6 months to < 18 years of age) and adult (18 to 65 years of age) subjects with primary dRTA.
About distal Renal Tubular Acidosis (dRTA) and ADV7103
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 triggers 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 (hypokalemia) 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 United States. There are currently no approved therapies for this disease.
About the Galien Foundation and Galien Medstartup award
The Galien Foundation fosters, recognizes and rewards excellence in scientific innovation to improve the state of human health. The Foundation oversees and directs activities in the USA for the Prix Galien, an international award that recognizes outstanding achievements in improving the human condition through the development of innovative therapies. The Prix Galien was created in France in 1970 in honor of Galien, the father of medical science and modern pharmacology.
Presented by the Galien Foundation and Business France, the Prix Galien – Medstartup encourages and rewards the most promising French startups in healthcare.
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 market authorization for dRTA in Europe in the coming months and anticipates its commercial launch in 2020 in Europe. In North America, the US FDA and Health Canada gave clearance to commence a pivotal Phase III clinical trial assessing ADV7103 in dRTA patients. Commercial launch in the United States is anticipated in 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. www.advicenne.com
Forward-Looking Statement
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 estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements, needs for additional financing. In some cases, you can identify forward-looking statements 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, they are based largely on the current expectations of Advicenne as of the date of this press release and 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 achievement 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 risk and uncertainties developed or identified in any public documents filed by Advicenne with the AMF, included those listed in chapter 4 “Risk factors” of its document de base filed with the French financial market authority (the Autorité des marches financiers) on October 31, 2017 under number I.17-071. 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.
