AcuCort has been awarded funding from Region Skåne to accelerate the company's commercial activities in the United States. The funding amounts to SEK 150,000 and will be matched by AcuCort, resulting in a total project budget of at least SEK 300,000.
"We have reached important regulatory milestones in our dialogue with the FDA and can now accelerate our commercial activities in the United States. Our focus is on identifying a strong commercial partner that can become involved at an early stage and contribute to a successful launch of Zeqmelit® in the US market," says Jonas Jönmark, CEO of AcuCort.
The FDA has previously granted AcuCort a Small Business Waiver, which exempts the company from the FDA's application fee for its forthcoming New Drug Application (NDA). AcuCort has also reached agreement with the FDA on an initial Pediatric Study Plan (iPSP), meaning that no additional studies need to be conducted before the NDA is submitted.
The project will include market and business analyses, the identification of potential commercial partners, meetings and participation in relevant life science events in the United States. The objective is to establish a commercial partnership for Zeqmelit® and lay the foundation for a future launch in the US market.
Region Skåne stated that the investment will contribute to sustainable growth and enhance the competitiveness of companies.
For further information:
Jonas Jönmark, CEO, AcuCort AB
Phone: 070 365 5400
E-mail: jonas.jonmark@acucort.se
About AcuCort AB (publ)
AcuCort has developed and is commercializing Zeqmelit®, a new rapidly dissolving oral film placed on the tongue, based on the well-known cortisone substance dexamethasone. The drug is a smart product in a new, innovative, patented, and user-friendly administration form primarily for the treatment of severe and acute allergic reactions, croup in children, nausea and vomiting during chemotherapy, and for the treatment of patients with COVID-19 requiring supplemental oxygen therapy. Zeqmelit® is approved in Sweden, Denmark, Norway, and Finland, where the product is also marketed. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market. Visit www.acucort.se for more information.