ExCEEd Orphan Distribution d.o.o., a Croatia based fully-owned subsidiary of ExCEEd Orphan s.r.o., a company providing full business solutions for the treatment of rare diseases, signed an exclusive Distribution Agreement with Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, for the distribution and marketing of Alkindi® (hydrocortisone granules in capsules for opening) and Efmody® (hydrocortisone modified-release hard capsules) in Central and Eastern European (CEE) countries.
Under the terms of the agreement, ExCEEd Orphan will receive the exclusive rights to distribute and market Alkindi® and Efmody® in the CEE countries including Albania, Bosnia and Herzegovina, Croatia, Czechia, Hungary, Kosovo, Montenegro, North Macedonia, Poland, Serbia, Slovakia, and Slovenia. Based on the Company’s estimates and market research conducted by ExCEEd Orphan, there are estimated to be in total around 9,500 patients in the CEE region suffering from paediatric adrenal insufficiency (AI) and adult congenital adrenal hyperplasia (CAH).
Alkindi® already has marketing authorisation in the European Union and is the first preparation of hydrocortisone specifically designed for use in children suffering from AI, including the related condition CAH. Efmody® is a modified-release preparation of hydrocortisone 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.
Jiri Hermanek, Chief Executive Officer and Founding Partner of ExCEEd Orphan, commented:
“We are very pleased to announce this collaboration to make Alkindi® and Efmody® available to patients with diseases of cortisol deficiency across Central and Eastern European countries. Both products will represent an important addition to the continuously growing portfolio of rare disease medications marketed and distributed by ExCEEd Orphan and we are fully committed to bringing these unique medications to all patients in needs in all respective countries.”
Martin Whitaker, Chief Executive Officer of Diurnal, commented:
“We are pleased to announce this distribution agreement with ExCEEd Orphan to make Alkindi® and Efmody® available to patients with diseases of cortisol deficiency across Central and Eastern Europe. Following this agreement, Diurnal’s products are now available to over two-thirds of the EEA population and we are looking forward to working with ExCEEd Orphan who have a strong track record of launching orphan medicines within this region.”
About Alkindi® (hydrocortisone granules in capsules for opening)
Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia (CAH). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from diseases due to cortisol deficiency including paediatric AI and CAH. AI requires life-long treatment and Diurnal’s novel approach to product development has the potential to significantly improve these young patients’ lives. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children, and adolescents (from birth to <18 years old) in Europe.
The human medicine European public assessment report (EPAR) for Alkindi® can be viewed here and the Summary of Product Characteristics (SmPC) here.
About Efmody® (hydrocortisone modified-release hard capsules)
Efmody® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day “toothbrush” regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age).
The human medicine European public assessment report (EPAR) for Efmody® can be viewed here and the Summary of Product Characteristics (SmPC) here.
About ExCEEd Orphan s.r.o.
ExCEEd Orphan was founded in 2018 by five rare disease experts from multiple Central and Eastern European (CEE) countries. The Company is focusing on innovative treatments for rare diseases and has extensive experience in launching innovative medicines in this field. The portfolio of ExCEEd Orphan includes products in therapeutic areas like haematology, neurology, immunology, and metabolic diseases.
For further information about ExCEEd Orphan, please visit www.exceedorphan.com
About Diurnal Group plc
Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.
For further information about Diurnal, please visit www.diurnal.com