AcuCort is entering a new and exciting phase, focusing on the commercialisation of our innovative and patient-friendly oral film Zeqmelit®, for acute and severe allergic reactions, among others.
The fourth quarter of 2022 has been characterised by continued intensive work to create the best possible conditions for the market launch that the drug is facing. AcuCort’s overall goal is to commercialise Zeqmelit® globally, i.e. in the EU, the US and in selected key markets.
During the period, we have achieved many positive milestones.
In October, the Swedish Medical Products Agency approved the name change to Zeqmelit® in Sweden, where the drug is already approved, but under the name ISICORT. In early 2023, we were also able to announce that Zeqmelit® had received trademark protection in all European Member States. The name change is a consequence of the fact that the brand name Zeqmelit® has proven to be the most suitable for most of the markets we have prioritised and for which registration processes are ongoing.
In November, we signed the first commercial agreement for Zeqmelit® through the distributor agreement with Kamada Ltd. for the Israeli market. Discussions are ongoing with a number of potential partners for other selected markets. We have set high standards, which means that our partner of choice must be reputable and have experience in the allergy business. Our strategy is to attract partners with a regional or global market presence and the ability to effectively launch Zeqmelit®.
In Sweden, we are now awaiting the outcome of the price and subsidy application submitted to the pricing authority TLV, Tandvårds- och läkemedelsförmånsverket. The application was preceded by a survey showing that an overwhelming majority, 72%, of patients surveyed would prefer a mouth film to tablet treatment in the event of a severe allergic reaction.
Other important milestones achieved during the year include, of course, the approval of Zeqmelit® in Denmark and Norway. We also received approval from the Finnish Medicines Agency at the beginning of 2023. This means that the drug is now approved throughout the Nordic region. These approvals are important in our discussions with potential partners and are of great significance in regulatory processes for other markets.
In early 2022, we were able to announce two pieces of positive news when AcuCort received news that the company had been exempted from the application fee from the FDA that would otherwise have cost the company over SEK 15 million. The company was also granted SME (micro, small or medium-sized enterprise) status by the European Medicines Agency (EMA). SME status provides certain administrative and financial advantages when applying for marketing authorisation in the EU.
Regarding the US – one of the world’s largest and most important markets for pharmaceuticals – we have a regulatory strategy in place with the goal of submitting a registration application to the US FDA in 2023. The FDA has requested additional information for this application, which may delay the process. However, in our view, this does not affect the likelihood of approval.
In preparation for commercialization, we have entered into an agreement with Adhex Pharma for the commercial and large-scale production of Zeqmelit® We have also signed an agreement with the consulting company TFS (TFS Trial Form Support AB) for pharmacovigilance (drug monitoring), which includes monitoring the side effects and safety of Zeqmelit®.
I am proud of the AcuCort team and all the many preparations we have made with a view to the successful commercialisation of Zeqmelit® in the global market. I am optimistic about next year and I would like to thank all our long-term shareholders and our partners who make our growth journey possible.
Chief Executive Officer, AcuCort