Kye Pharmaceuticals signs exclusive licence and distribution agreement with AcuCort for Zeqmelit® in Canada

Kye Pharmaceuticals is pleased to announce that it has entered into an exclusive licence and distribution agreement with AcuCort AB, a Swedish pharmaceutical company, for Zeqmelit^®, a rapidly dissolving dexamethasone oral film.  The agreement represents another important step in Kye's portfolio expansion and mission of bringing Canadians medicines that fulfill clinically significant unmet needs.

MISSISSAUGA, ON, Nov. 9, 2026 /CNW/ -- The commercial agreement grants Kye Pharmaceuticals exclusive rights to register, market, distribute and sell Zeqmelit^® in Canada. The regulatory submission is planned for early 2027. Subject to marketing authorisation from Health Canada, launch is expected in 2028.

The agreement includes an upfront payment, a regulatory milestone as well as milestone payments and royalties based on net sales.

Kye Pharmaceuticals is a Canadian specialty pharmaceutical company with an established presence in market segments relevant to Zeqmelit^®, including multiple therapies for paediatrics. Since 2024, Kye has launched seven innovative prescription pharmaceutical products in Canada, demonstrating its experience in bringing new medicines to the Canadian market.

Dexamethasone is a potent corticosteroid (i.e. glucocorticoid) that is used to treat conditions involving dysregulated immune and inflammatory pathways¹. Severe inflammatory reactions that require urgent administration of dexamethasone can be complicated by an inability to swallow and deliver precise dosages². The fast-dissolving oral film (orodispersible film) drug delivery technology can ensure the rapid and accurate administration of dexamethasone directly through the lining of the mouth³.

Zeqmelit^® combines the well-established efficacy and safety profile of dexamethasone with an innovative oral film formulation designed for real-world administration challenges. For acute allergic reactions where rapid intervention is required, Zeqmelit's water-free, fast-dissolving oral film offers a convenient alternative to traditional tablets and liquid formulations. Its patient-friendly format may facilitate administration in children or elderly patients who have difficulty swallowing^{4, 5}.

"The agreement is an important step in our international expansion and gives us a commercial partner with relevant experience and an established presence in the Canadian market, which comprises more than 40 million people. At the same time, the agreement establishes a clear revenue model for AcuCort, with an upfront payment and further revenue opportunities linked to milestones and future sales of Zeqmelit^®. This is precisely the type of partnership on which our international strategy is based," says Jonas Jönmark, CEO of AcuCort.

John McKendry, CEO of Kye Pharmaceuticals, comments:

"Zeqmelit^® is an important strategic addition to our product portfolio and aligns well with our mission to bring innovative medicines to Canadian patients that address significant unmet clinical needs. Zeqmelit^® will benefit from our strong sales organisation in paediatrics while also extending our market reach into other therapeutic areas, including allergy and respiratory diseases."

Zeqmelit^® is currently marketed in Sweden, Denmark, Norway and Finland. AcuCort also has an existing commercial agreement with Glenmark Pharmaceuticals for Zeqmelit^® in Germany, the Netherlands, the Czech Republic, Austria, Slovakia and Ukraine.

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 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.

About Kye Pharmaceuticals
Kye is a leading specialty pharmaceutical company committed to bringing value to Canadians by identifying, licensing, and commercializing novel prescription medicines that may not otherwise be available to patients across Canada. With a growing pipeline of innovative medicines, Kye's portfolio spans a range of therapeutic areas including cardiology, psychiatry, pediatrics, rare diseases, neuromuscular, hematology, and neurology. Kye Pharmaceuticals is a private company, founded in Canada and focused exclusively on the healthcare needs of patients in Canada. Kye aims to provide medicines that deliver better outcomes to our partners, healthcare professionals, and most importantly, patients across Canada. Kye, headquartered in Mississauga, Ontario was recognized on the Globe & Mail list of Canada's Top Growing Companies for 2025 and 2026.

Website: https://www.kyepharma.com/

References: 
[1] Johnson DB, Lopez MJ, Kelley B. Dexamethasone. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023. Updated May 2, 2023. Available from: https://www.ncbi.nlm.nih.gov/books/NBK482130/

[2] Löfvendahl S, Andersson E, Wahlberg K, Bjermer L, Tornling G, Hjelmgren J. Treatment preferences for acute allergic reactions: a discrete choice experiment. Journal of Health Economics and Outcomes Research. 2024;11(1):157-165. doi:10.36469/jheor.2024.117589.

[3] Pai VB, Nahata MC. Extemporaneous Formulations for Pediatric Patients: Global Necessities, Challenges and Opportunities. Pharmaceutics. 2026;18(1):126. doi:10.3390/pharmaceutics18010126.

[4] Bjermer L, Tornling G, Kereki J, Wahlberg K, Javizian B, Hjelmgren J. A Real-World Clinical Trial Evaluating Satisfaction and Experiences with a Dexamethasone Mouth Film Compared to Corticosteroid Tablets as Rescue Medication for Moderate to Severe Acute Allergic Reactions. Journal of Market Access & Health Policy. 2026;14(3):43. doi:10.3390/jmahp14030043.

[5] Zeqmelit® (dexamethasone) orodispersible film. Summary of Product Characteristics (SmPC). Swedish Medical Products Agency (MPA). Available from: https://docetp.mpa.se/LMF/Zeqmelit%20orodispersible%20film%20ENG%20SmPC_09001bee82f82c31.pdf 

SOURCE Kye Pharmaceuticals Inc.

Media and Investor Contact: John McKendry, CEO, Kye Pharmaceuticals, 1-888-822-7126, [e-mail]; Denise David, VP Scientific Affairs, Kye Pharmaceuticals, 1-888-822-7126, [e-mail]