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Advicenne Announces Submission of European Marketing Authorization Application (MAA) for ADV7103 as Treatment for Distal Renal Tubular Acidosis (dRTA)

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Wednesday, March 13, 2019

Advicenne, specializing in the development of adult and pediatric therapeutic products for the treatment of orphan renal and neurological diseases, announces  that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead drug candidate, ADV7103, as a treatment for distal renal tubular acidosis (dRTA).

The application comes after positive results in a pivotal Phase III clinical trial (B21CS) and its twenty-four-month extension study (B22CS). In view of patient numbers and the absence of approved treatments for dRTA, ADV7103 had previously received orphan medicinal product designation in Europe in 2017.

Marketing authorization for ADV7103 is anticipated in mid-2020. This schedule is in keeping with the late-2020 commercial launch strategy announced by Advicenne at its IPO: directly in the five principal European markets (France, Germany, Italy, Spain, United Kingdom) and through partnerships in other European Union countries.

With Ozalin® (ADV6209), which received authorization in September of 2018, approval for ADV7103 would make Advicenne one of the very rare French biotechnology companies to obtain two marketing authorizations for innovative products developed in-house.

"This European marketing authorization application represents a major step in Advicenne's growth," observes Caroline Roussel, Advicenne Co-Founder and Director of Operations, "one made possible by the outstanding work of our teams."

"This application fulfills the milestones announced at Advicenne's initial public offering. In addition to its first obtained MAA, this application promotes the company to a quite advanced development stage" concludes Dr. Luc-André Granier, Chief Executive Officer of Advicenne, "We are delighted to be actively preparing the commercial launch of ADV7103."

About Distal Renal Tubular Acidosis (dRTA)

dRTA is an orphan disease characterized by a failure in the renal excretion of the acids generated through metabolism. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications. These include growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels (hypokalemia), high calcium levels (hypercalcemia), elevated calcium in the urine (hypercalciuria) resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure.

Whether genetic, or acquired as a consequence of an autoimmune disease, dRTA affects an estimated 30,000 patients in Europe and approximately 20,000 in the United States.

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 of distal Renal Tubular Acidosis (dRTA) in children and adults, leading to its recent submission for European marketing authorization. The commercial launch of ADV7103 in Europe is anticipated for late-2020.

In North America, ADV7103 has received clearance from the US Food and Drug Administration and Health Canada for a pivotal Phase III clinical trial for the treatment of dRTA patients. Commercial launch in the United States is anticipated for 2021.

In addition to dRTA, ADV7103 is currently in Phase III clinical studies for a second indication, cystinuria, an inherited renal tubulopathy.

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

www.advicenne.com

Contacts

Advicenne
Luc-André Granier, Paul Michalet,
Julie Rachline
E-mail: investors@advicenne.com
+33 (0)4 66 05 54 20

Source: Advicenna
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