Diurnal announced this morning that it has extended its existing distribution agreement for Alkindi and Efmody with Er-Kim to include Greece, Cyprus and Malta.
The extension adds to the previous agreement for Turkey, Bulgaria and Romania. It reflects Diurnal's desire to ensure that these distribution agreements maximise the commercial potential of its adrenal franchise, and as many patients as possible benefit from their availability.
Er-Kim is an interesting distribution partner with aspirations to bring treatments for unmet needs into Turkey as well as other European and Middle Eastern countries. Under the terms of the agreement, Er-Kim will benefit from exclusive rights to distribute and market Diurnal's cortisol replacement products for the treatment of patients with low cortisol disorders. Alkindi represents a paediatric formulation of hydrocortisone, while Efmody provides physiological cortisol levels mimicking the body's diurnal rhythm. Efmody reduces the build-up of overnight androgens and the risk of an adrenal crisis in patients suffering from the genetic disorder congenital adrenal hyperplasia (CAH). We believe Efmody to be the more important product commercially for Diurnal. In the release today, we note that these additional countries offer a commercial opportunity of circa €7m. As a result of Diurnal's commercial go-to-market strategy, Alkindi and Efmody are now available in 20 countries in the European Union.
Although the market potential for Alkindi may be modest, the combination of Alkindi and Efmody will ultimately provide improved treatment options for the continuum of patients with adrenal insufficiency, including CAH, from childhood through to adulthood. We remain early in this journey, with Efmody currently approved for adolescent and adult CAH in Europe. However, studies are ongoing to take Efmody into AI in Europe with the CHAMPAIN trial (data available end 2022), and in CAH in the US, with the Phase 3 CONnECT study also underway. As data from these studies become available, we anticipate a greater appreciation of the benefit associated with Efmodys circadian delivery of hydrocortisone, particularly in CAH patients, who suffer from a build-up of androgens overnight.
We look forward to the full suite of Diurnal's AI (including CAH) products becoming available over the coming years.
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Diurnal Group is a client of Calvine Partners, and as such, this publication is not independent and should be considered a marketing communication under FCA Rules. None of the information contained in this publication should be considered as any form of advice.