Lund-based AcuCort is currently making a journey from a research-oriented biotechnology company to a commercial player with global ambitions. With the fast-dissolving oral film Zeqmelit, the company wants to revolutionize the treatment of acute allergic reactions and other conditions where rapid medication can be life-saving. With an oversubscribed issue and potential new capital on the way via the TO2 warrant, the company is equipped to intensify the launch work and take Zeqmelit to more markets.
AcuCort focuses on identifying, developing and commercializing pharmaceuticals based on well-documented substances. The company's flagship product, Zeqmelit, is a fast-dissolving oral film containing the corticosteroid dexamethasone, a substance used globally since the 1960s for its anti-inflammatory and immunosuppressive properties.
Unlike traditional tablets or injections, Zeqmelit dissolves on the tongue within 10–15 seconds, making it easy to use in emergency situations, even without access to water. This makes the product particularly attractive to allergy sufferers who need rapid relief in cases such as anaphylactic shock.
Great interest from the industry
Zeqmelit is approved in the Nordic countries for the treatment of acute and severe allergic reactions, croup in children, nausea and vomiting during chemotherapy and for COVID-19 patients requiring oxygen therapy. The product was launched in Sweden, Norway and Finland in the autumn together with Unimedic Pharma.
Jonas Jönmark, who visited earlier this year BioStock studio, is very pleased with the initial sales, and interest in the product is expected to increase as the allergy season in spring 2025, when more patients renew their prescriptions. The medical community has shown great interest in Zeqmelit, and the company has actively engaged allergists and professors in roundtable discussions to increase awareness of the product.
Aiming at Europe and the USA
The collaboration with Unimedic Pharma has been crucial to the success in the Nordic region. The partner is responsible for sales and marketing, and the sales team has reported strong interest from the market. AcuCort now aims to expand the launch into Europe and the US, through partnerships with licensees and distributors. AcuCort is in discussions with potential European distributors and according to Jönmark, the talks are well advanced. In Europe, priority is given to the larger markets such as Germany, France and the UK, where dexamethasone is already well established.
Outside Europe and the US, the company recently signed a letter of intent with Dubai-based Lunatus regarding the Middle East and the Gulf States. Lunatus is well established in the region and represents, among others, companies such as Abbott Diagnostics and Boston ScientificThe two parties aim to reach a commercial agreement in 2025.
– The letter of intent is an important step in our international growth strategy. We see great potential for Zeqmelit in the region, comments Jönmark.
Continuing to build evidence
In parallel with the market launch, the company continues to build clinical evidence. In November, a phase IV study (ZEQ001) was completed with 50 patients, the purpose of which was to collect data on patient experiences of Zeqmelit compared to traditional treatments. The results, which are expected to be published in scientific journals, confirm Zeqmelit's ease of use and effectiveness.
In parallel with the launch in the Nordics, AcuCort has advanced its regulatory process for the US market. In February, the company submitted a supplementary Initial Pediatric Study Plan (iPSP) to the FDA, an important step towards a full application for market approval (New Drug Application, NDA). The company expects to be able to submit the NDA application in the second half of 2025, which would open the door to a market worth over USD 3 billion.
Oversubscribed issue in weak market, a sign of strength
It is not only the industry that has shown great interest in AcuCort and Zeqmelit. Despite a very tough financing climate, the company carried out a very successful rights issue at the beginning of the year. The issue was oversubscribed by approximately 160 percent and provided the company with SEK 47,7 million before issue costs. The capital is earmarked to finance the continued market launch in the Nordic region, the regulatory processes in the US and Europe, and to strengthen the organization for global expansion.
The issue also included warrants of series TO2, whose exercise period runs until June 20. Through it, the company can raise an additional up to SEK 23,8 million to drive the ongoing launch work.
Is the company a good investment then? If you ask Jönmark, he highlights the fact that the case is associated with a relatively low development risk. In addition, Zeqmelit is approved in several countries and based on a well-established substance, which makes the company an attractive investment for those seeking exposure to the life science sector.
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