History

Diurnal is a global endocrine specialty pharmaceutical company dedicated to addressing major unmet clinical and patient needs in hormone replacement by creating effective, high quality products for life-long treatment of chronic endocrine disorders

History:

2021

• Efmody® receives Market Authorisation approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA)
• Efmody® receives Market Authorisation approval from the European Commission
• Efmody® distribution and marketing agreement signed with Consilient Health for the Nordic region
• Licensing agreement signed with Citrine Medine for Efmody® and Alkindi® covering China, Hong Kong, Taiwan and Macau
• Licencing agreement with Eton Pharmaceutical for Alkindi® extended to Canada
• Distribution agreement signed with Er-Kim for Alkindi® and Efmody® covering Turkey, Bulgaria and Romania
• Chronocort® Market Authorisation Application submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA)

• Alkindi® approved by the FDA in the US
• Alkindi® available to US patients through licensing agreement with Eton Pharmaceuticals
• Alkindi® approved in Australia and Israel
• Confirmation of 505(b)(2) regulatory pathway for DITEST™ from FDA

• Chronocort® Market Authorisation Application submitted to European Medicines Agency
• Alkindi® New Drug Application submitted in the US
• Positive DITEST™ oral native testosterone results from Phase 1 trial in hypogonadal patients
• Alkindi® Orphan Drug Designation granted and Market Authorisation Application submitted in Australia
• Alkindi® Market Authorisation Application submitted in Israel

• Chronocort® Phase 3 trial completed in Europe
• Alkindi® receives approval from the Scottish Medicines Consortium
• Alkindi® launched in Germany and the UK generating first sales
• Alkindi® receives market authorisation approval from European Commission

• Alkindi® receives positive opinion for approval from European Medicines Agency
• Alkindi® and Chronocort® patents granted in the US

• Infacort® Market Authorisation application submitted to the EMA
• Chronocort® Phase 3 trial commenced in Europe
• Diurnal successfully dosed first patient in DITEST Phase I clinical trial
• First year end results posted
• Full results announced from positive European Infacort® Phase III study
• Positive headline data from European Infacort® Phase III pivotal study reported
• Diurnal announces first interim results
• First patient dosed in Chronocort® pivotal Phase III clinical trial in Europe

• Diurnal admitted to AIM on the 24th December
• Chronocort® granted Orphan Drug Designation by the FDA for Adrenal Insufficiency in the US
• Peter Allan is appointed as Non-Executive Chair of the Board of Directors and Ian Ardill joins as the Chief Financial Officer.
• FDA grant Orphan Drug Designation to Infacort® in the US
• Infacort® Phase 3 trials commenced in Europe
• Diurnal secures venture capital funding to initiate Phase 3 registration trials of both Infacort® and Chronocort®

• Phase 2 CATCH trial results published in the Journal of Clinical Endocrinology and Metabolism (JCEM)
• Positive results from the Phase 2 CATCH trial are presented at the ENDO conference in Chicago, USA

• CATCH Phase 2 trial in patients begins at the National Institutes of Health (USA) under a CRADA collaborative agreement
• Positive Infacort® Phase 1 trials in healthy adult volunteers enable Diurnal to progress Infacort® trials in paediatric patients

• Paediatric Investigation Plan (PIP) for Infacort® approved by the European Medicines Agency
• Diurnal successfully concludes Chronocort® Phase 1 trials in healthy adult volunteers. This enables Diurnal to progress Chronocort® trials in patients
• Martin Whitaker is promoted to CEO

• Diurnal, as part of the TAIN Consortium, secures a prestigious FP7 grant worth €4.2 million from the European Commission to develop its second product Infacort®

• Diurnal headquarters established at Cardiff MediCentre in Wales (UK)

• Venture capital funding base established and development partners are engaged to develop Chronocort®

• Phoqus Pharmaceuticals returns all product development rights to Diurnal. A new management team is created and Martin Whitaker is installed as the General Manager. Chief Development Officer Hiep Huatan joins Diurnal

• An Orphan Drug Designation was approved by the European Medicines Agency for Chronocort® for the rare disease Adrenal Insufficiency

• Diurnal is founded as a spin-out from the University of Sheffield (UK) based on the expertise of Professor Richard Ross. Professor Ross, who is based at the University of Sheffield School of Medicine, is a world expert on endocrine conditions. His detailed understanding of chronic endocrine conditions has led him to create innovative pharmaceutical products that mimic the body’s natural hormone rhythm with the potential to improve patient’s lives
• Product development begins with Phoqus Pharmaceuticals plc (UK) through a development agreement
• Two Orphan Drug Designations are received from the European Medicines Agency for the rare chronic diseases Congenital Adrenal Hyperplasia and Adrenal Insufficiency

Diurnal Group plc (Company Number: 09846650) is registered in England & Wales. Registered office: Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, UK.