Specialist pharmaceutical company Diurnal (DIU:AIM), which targets patients with chronic hormonal diseases, reported strong growth in revenues to £6.3 million for the 12 months ended 30 June 2020, pushing the shares 4.5% higher to 59p.
The company has developed and commercialised Alkindi, a drug aimed at children suffering from cortisol deficiency. Cortisol is a steroid hormone that helps the body to respond to stress by increasing the body’s metabolism of glucose and controlling blood pressure.
Sales of Alkindi increased 130% to £2.4 million after launching in the UK, Germany and Austria with subsequent access approved in Sweden, Denmark, Norway Iceland and Italy.
In the US, the company received a regulatory pathway from the Federal Drug Agency (FDA) in February, and in April it signed a licensing deal with Nasdaq-listed specialty pharmaceutical company Eton, resulting in a payment of $3 million in cash and $1.5 million in shares.
Diurnal will receive a further $2.5 million in cash after the first commercial sale. The company believes the US market opportunity for Alkindi to be worth around $100 million.
In European markets the company has developed its own small sales and marketing infrastructure to sell the product into specialist endocrine centres while it looks for distribution partners in the rest of the world.
The group’s second cortisol product Chronocort is designed to provide a drug release profile that better mimics the body's natural cortisol circadian rhythm, which current therapies are unable to replicate, to improve disease treatment in adults.
The product is expected to receive formal approval from the European Medicines Agency, which regulates and approves drugs, in the second quarter of 2021.
The company is also developing a native oral testosterone deficiency drug called DITEST which the FDA has given a clear regulatory pathway.
Continued strong growth in Aldindi and a number of key milestones over the next 12 months are expected to be ‘major inflection points’, allowing Diurnal to build 'a strong, profitable franchise around diseases of cortisol deficiency.’