AcuCort Reaches Agreement with Pharmaceutical Manufacturer Adhex Pharma for Commercial, Large-Scale Production of ISICORT®

AcuCort AB (post) (Stock market: ACUC) announced today that the company has signed an agreement with contract manufacturing company Adhex Pharma for large-scale, commercial production of ISICORT®. This product supply agreement is an important step for the upcoming commercialization of ISICORT®.

Under the terms of this agreement with the subcontractor Adhex Pharma, AcuCorte secures the commercial and large-scale production of its drug ISICORT®, and in compliance with GMP (Good Manufacturing Practices). Thus, through this agreement, the supply of ISICORT® product is ensured upstream of future marketing. Adhex Pharma is a French company specialized in technologies for the production of medical patches and thin oral films.

Already in 2017, AcuCorte and Adhex Pharma (then trading as PlastoPharma) entered into a collaboration with the aim of completing product development, scaling up commercial scale production and manufacturing the batches for bioequivalence studies in the EU and United States as well as for regulatory applications. The previous collaboration agreement also laid the foundation for a future manufacturing and supply agreement applying 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 require supplemental oxygen therapy. Intensive work is underway with registration applications for other priority markets.

“The conclusion of this new agreement with Adhex Pharma regarding the commercial and large-scale production of ISICORT® marks an important step before the commercialization to come. In addition, we have several years of experience of a

and an effective collaboration with Adhex Pharma which is an excellent prerequisite for a secure supply of products. We look forward to the exciting introduction of ISICORT® to the market when the drug becomes available for prescription by physicians and benefits the patient,” said Jonas Jönmark, CEO of AcuCorte.

The information has been submitted for publication, through the contact person below, the February 22, 2022.

For more information please contact:
Jonas Jonmark, CEO, AcuCort AB
Telephone: + 46 (0)70 365 5400
Email: [email protected]

On AcuCort AB (publication)
AcuCorte has developed and markets ISICORT®, a new, fast-dissolving oral film to be applied to the tongue, based on a well-known cortisone-based 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 request has been approved by the Swedish Medical Products Agency (MPA) in October 2020. In February 2021, ISICORT® has been granted an additional indication – the treatment of COVID-19 patients who require supplemental oxygen therapy. Overall, this reinforces the Company’s assessment that ISICORT®’s time to market could be relatively short. AcuCorte (ticker: ACUC) is listed on the Stock market in Sweden. Please visit www.acucort.com.

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