Diurnal outsources launch of Adrenal drug to Dublin divisions of UDG
Diurnal Ltd is a Cardiff, Wales-based subsidiary of Diurnal Group plc, developing therapies for chronic endocrine diseases. These include chronic and rare circadian (sleep), adrenal and thyroid disorders.
Both Ashfield and Sharp are divisions of the Dublin-based CRO UDG Healthcare plc. Ashfield provides commercial and pharmacovigilance services and has been chosen by Diurnal to help it build sales and medical infrastructure in major European territories.
Sharp Packaging Services, on the other hand, will help prepare the firm’s lead candidate – Infacort – for commercialization, in line with new serialization regulations for the US and EU markets.
Infacort is an oral hydrocortisone granule formulation with taste-masking excipients to help with pediatric patient compliance, estimated to be launched this year to treat Pediatric adrenal insufficiency (Addison's Disease).
Martin Whitaker, CEO of Diurnal, said “Following the submission of our regulatory application to the EMA for Infacort and its subsequent validation, we are focused on pre-launch activities for this product in Europe.”
“We are confident that the agreements with Ashfield and Sharp, both leading providers of outsourced commercialisation services to the pharmaceutical industry, will help ensure the prompt and effective market introduction of Infacort,” he added.
UDG also claims Sharp is also a world leader in ‘Track and Trace’ serialization services, to help firms apply unique serial codes to ensure authenticity and traceability of pharmaceutical products.
This is of particular importance given the recent changes in regulations for the Pharma industry, which will make serialization compulsory for licensed products in the US and EU. The new rules will come into effect later this year in the US, and by 2018 for Europe.
Sharp has 9 facilities across the EU and US for commercial service packaging, which UDG Healthcare previously told Outsourcing-Pharma accounts for 24% of the group’s profits.
“We will be able to support Diurnal in successfully launching treatments for chronic endocrine diseases across key European markets,” said Mark Gibson, Director of international business at Ashfield.