LONDON: Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, has extended its distribution and marketing agreement with EffRx Pharmaceuticals (“EffRx”) in Switzerland to now include Efmody® (hydrocortisone modified-release hard capsules).
Under the agreement signed in October 2020, EffRx already holds the exclusive rights to market and distribute Alkindi® (hydrocortisone granules in capsules for opening) in Switzerland. Alkindi® was approved by Swissmedic in November 2021.
EffRx intends to submit a Market Authorisation Application (MAA) to Swissmedic for the registration of Efmody® as treatment for adolescent and adult patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH) in Switzerland during the second half of 2022.
The MAA submission to Swissmedic for Efmody® will be based on the European regulatory dossier and published clinical trial data, with EffRx expecting potential market launch in Switzerland in 2024. Under the terms of the agreement, EffRx will receive the exclusive rights to market and sell Efmody® in Switzerland once registered. According to the Company’s estimates, there are approximately 450 patients in Switzerland suffering from CAH.
Efmody® is a modified-release preparation of hydrocortisone that has been specifically designed for the treatment of patients with CAH, a rare condition caused by a genetic deficiency of adrenal enzymes. In May 2021, Efmody® was granted marketing authorisation in the European Union and was subsequently launched by the Company in Germany, Austria and the UK in September 2021.
On successful approval in Switzerland, Diurnal will provide Efmody® to EffRx for sale from its established European supply chain.
Richard Bungay, Interim Chief Executive Officer of Diurnal, commented: “We are pleased to deepen our relationship with EffRx to include the distribution and marketing of Efmody® in Switzerland. We have been impressed by the progress EffRx has made with the regulatory approval and reimbursement of Alkindi® and look forward to continuing to work with them as they prepare to submit an MAA to Swissmedic for Efmody®.”
Lorenzo Bosisio, Chief Executive Officer of EffRx, commented: “We are excited to sign this additional agreement with Diurnal, enabling us to build on the momentum we have achieved with Alkindi® in Switzerland following approval from Swissmedic in November 2021. We believe the unique release profile of Efmody®, that mimics the body’s natural cortisol circadian rhythm, could have a genuine impact on CAH patients’ symptoms. We are aligned with Diurnal’s strategy to address the unmet medical need in patients suffering from diseases of cortisol deficiency and look forward to working with the Diurnal team to bring Efmody® to patients suffering from CAH in Switzerland.”
