AcuCort AB (Spotlight Stock Market: ACUC) announced today that the registration process in Denmark, Finland, Iceland and Norway regarding the company’s drug ISICORT® is currently ongoing via a so-called reciprocal procedure, Mutual Recognition Process (MRP). ISICORT® has previously been approved in Sweden.
In the development of ISICORT®, the advantages of the commonly prescribed and well-documented anti-inflammatory substance dexamethasone and the administration of a fast-dissolving oral film have been combined into a new drug.
The innovative drug has a rapid uptake of the active substance dexamethasone, and it does not need to be swallowed and does not require water, which is an important benefit for rapid relief in acute situations such as acute and severe allergic reactions. Not least for children and persons with swallowing difficulties. ISICORT® is an approved drug in Sweden primarily for the treatment of severe and acute allergic reactions, croup in children, chemotherapy-induced nausea and vomiting (CINV) as well as for the treatment of COVID-19 patients who need supplemental oxygen treatment.
“The fact that the registration process for ISICORT® has now been initiated in the Nordic countries is an important step in our commercialization strategy. An approval of the drug in all Nordic countries means that we also strengthen AcuCort’s position in the ongoing discussions with potential commercial partners in the Nordic market. We anticipate a positive decision from the regulatory authorities in the first quarter of 2022. An approval in the Nordic region is to AcuCort’s advantage as well in our ongoing partner dialogues in other priority markets,” says Jonas Jönmark, CEO of AcuCort AB.
The information was submitted for publication, through the agency of the contact person below, on November 15, 2021.
For more information, please contact:
Jonas Jönmark, CEO, AcuCort AB
Telephone: + 46 (0)70 365 5400
Email: Jonas.jonmark@acucort.se
About AcuCort AB (publ)
AcuCort develops and commercializes ISICORT®, a new fast-dissolving oral film to put on the tongue, based on a well-known cortisone substance – dexamethasone. ISICORT® is a smart product in a new, innovative, patented and user-friendly dosage form primarily for the treatment of severe and acute allergic reactions, croup in children and chemotherapy induced nausea and vomiting (CINV). A national application was approved by the Swedish Medical Products Agency (MPA) in October 2020. In February 2021, ISICORT® was granted an additional indication – the treatment of COVID-19 patients who need supplemental oxygen treatment. Altogether, this strengthens the company’s assessment that the time to commercialization of ISICORT® may be relatively short. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market in Sweden. Please visit www.acucort.com.