ZUG, Zwitserland – (BUSINESS WIRE) -Het Zwitserse bedrijf Primex Pharmaceuticals AG kondigt aan dat het in de EU een vergunning heeft ontvangen voor het in de handel brengen van OZALIN® (ADV6209). Het kalmeringsmiddel is bestemd voor kinderen van 6 maanden tot 17 jaar voor matige sedatie vóór therapeutische of diagnostische procedures en als premedicatie voorafgaand aan anesthesie.
Primex Pharmaceuticals verwierf de wereldwijde rechten voor OZALIN van het Franse farmaceutische ontwikkelingsbedrijf Advicenne SA.
‘Primex Pharmaceuticals AG: OZALIN – the First Oral Paediatric Sedative Licensed in the EU’.
ZUG, Switzerland–(BUSINESS WIRE)– Swiss company Primex Pharmaceuticals AG announces it has received marketing authorization (MA) in the EU for OZALIN® (ADV6209) for children from 6 months to 17 years for moderate sedation before therapeutic or diagnostic procedures, and as premedication prior to anaesthesia.
Primex Pharmaceuticals acquired the global rights for OZALIN from the French pharmaceutical development company Advicenne SA.
Dr. Luc-André Granier, CEO of Advicenne, comments: “As one of the very first in-house developed products, this MA validates our strategy and capabilities in developing original paediatric-adapted drugs.
Dr. Michael Brackhahn, from the Children’s Hospital in Hannover, Germany, presented results from the clinical studies and his own experience with OZALIN last week at the European Society of Paediatric Anaesthesia. “The results show the rapid sedative effect with good acceptability by paediatric patients in clinical practice.”
Alan Knox, Head of Global Marketing at Primex Pharmaceuticals, comments: “For children, there is a large unmet need for premedication prior to anaesthesia, and a huge unmet need for procedural sedation, such as in emergency and diagnostic procedures. OZALIN will reduce children’s fear and anxiety prior to surgical procedures.”
Kari Sarvanto, CEO of Primex, adds: “This is an important step for Primex in paediatric anaesthesia. The annual sales potential is between 100 million and 350 million euros, but more importantly, we can really make a difference here. This will pave our way to future new indications and products in anaesthesia and paediatrics.”
About Primex Pharmaceuticals
Primex Pharmaceuticals aims to become the leading global innovative anaesthesia company, and to expand in paediatric pharmaceuticals.
Primex Pharmaceuticals’ global partner network operates in over 40 countries. The company is headquartered in Switzerland and all Primex products are manufactured in Europe. Primex Pharmaceuticals has proven underlying business operations and historical strong revenue growth. www.primexpharma.com
Advicenne (Euronext: ADVIC) is a pharmaceutical company developing paediatric-friendly therapeutics for the treatment of orphan renal and neurological diseases.
Advicenne is listed on the regulated market of Euronext in Paris (ISIN: FR0013296746; Euronext ticker: ADVIC). The Company, which was established in 2007, is headquartered in Nîmes, France. www.advicenne.com
Primex Pharmaceuticals AG
Mr Kari Sarvanto, CEO
Mobile: +41 796 162 694