AcuCort receives market approval from the Swedish Medical Products Agency for the drug ISICORT®

7 oktober, 2020

AcuCort AB (Spotlight Stock Market: ACUC) has today received the market approval from the Swedish Medical Products Agency for the drug ISICORT®. This strengthens the company’s assessment that the time to commercialization may be relatively short.

ISICORT® is a thin, fast-dissolving and user-friendly oral film for the treatment of acute and severe allergic reactions, for croup in children and chemotherapy-induced nausea and vomiting (CINV). The fast-dissolving oral film contains the glucocorticoid dexamethasone which is a well-known, often used and well-documented anti-inflammatory substance.

“AcuCort has today passed an important milestone, both as a company and for our innovative drug ISICORT®. We are delighted and it feels inspiring that ISICORT® is approved in Sweden as the first country and that we can continue the growth journey according to our business strategy. The Swedish Medical Products Agency’s market approval means that we can now put full effort into the continued work of getting price and reimbursement accepted before we introduce ISICORT® on the market. Furthermore, we continue our partner dialogues and the work for market approval on more markets,” says Jonas Jönmark, CEO of AcuCort AB.

This information is information that AcuCort AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person below, on October 7, 2020.

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). The bioequivalence study that forms the basis of the application for marketing approval in Europe was carried out with positive results and the Swedish national application was approved by the Swedish Medical Products Agency in October of 2020. 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.