AcuCort AB (publ) (Spotlight Stock Market: ACUC) announced today that the company has signed an agreement with the contract manufacturing company Adhex Pharma regarding commercial and large-scale production of ISICORT®. This product supply agreement is an important milestone for the upcoming commercialization of ISICORT®.
Under the terms of this agreement with the contract manufacturer Adhex Pharma, AcuCort secures the commercial and large-scale production of its drug ISICORT®, and in line with GMP (Good Manufacturing Practice). Thus, by this agreement the product supply of ISICORT® is ensured ahead of the upcoming commercialization. Adhex Pharma is a French company specializing in technologies to produce medical patches and thin oral films.
Already back in 2017, AcuCort and Adhex Pharma (then under the name PlastoPharma) entered a collaboration with the goal of completing the product development, upscaling the production to commercial large-scale, and manufacturing the batches for the bioequivalence studies in the EU and USA as well as for regulatory applications. The previous collaboration agreement also laid the foundation for a coming manufacturing and supply agreement to apply to the commercialization of the future product, which has now resulted in this new agreement between the parties.
ISICORT® is a thin, small fast-dissolving oral film that is placed on the tongue where the active anti-inflammatory substance, dexamethasone, dissolves quickly and provides effective relief. ISICORT® is approved in Sweden for the treatment of acute and severe allergic reactions, croup in children, chemotherapy-induced nausea, and vomiting (CINV) as well as COVID-19 patients who need supplemental oxygen treatment. An intensive work is underway with registration applications for other priority markets.
“Entering this new agreement with Adhex Pharma regarding the commercial and large-scale production of ISICORT® marks an important milestone ahead of the upcoming commercialization. Furthermore, we have several years of experience from a constructive and effective collaboration with Adhex Pharma which is an excellent prerequisite for a secure product supply. We look forward to the exciting market introduction of ISICORT® when the drug will be available for prescription by the physicians and will benefit the patient,” says Jonas Jönmark, CEO of AcuCort.
The information was submitted for publication, through the agency of the contact person below, on February 17, 2022.
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 has developed 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.