Alkindi®: On route to Europe

Diurnal is a clinical stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead candidates are targeted at rare diseases with unmet medical need, with the aim of building a long-term ‘Adrenal Franchise’. Following successful completion of a Phase III trial, Alkindi® (previously known as Infacort®) has received a positive opinion from the CHMP, recommending the granting of market authorisation for replacement therapy in adrenal insufficiency for children from birth up to 18 years of age. The European Commission is expected to grant market approval in February, allowing first sales in 2Q 2018.

• Strategy: Diurnal’s strategic goal is to create a valuable ‘Adrenal Franchise’ that can treat patients with chronic cortisol deficiency diseases from birth through to old age. Once Infacort and Chronocort are established in EU and the US, the long-term vision is to expand the product offering to other related conditions.
• CHMP positive opinion: On 14th Dec 2017, and based on the solid Phase III trial results, the committee for Medicinal Products for Human Use (CHMP) provided a positive opinion, recommending the European Commission to grant marketing authorisation for Alkindi. The final rubber stamp is expected in February 2018.
• Launch: Infacort will be marketed under the tradename Alkindi for neonates and children up to 18 years of age. In anticipation of marketing approval and authorisation of the PUMA dossier, Diurnal has been establishing its commercial infrastructure in Europe, with first market launch now expected in 2Q 2018.
• Risks: While there is a risk with all drugs in development that they might fail clinical trials or not be approved by the regulators, Diurnal was considered to have unusually low risk because its products are formulation variants of wellestablished drugs. This stance has been validated by the positive CHMP opinion.
• Investment summary: Alkindi, a cortisol replacement therapy designed for children and babies, will be Diurnal‘s first product on the market. It will be followed by Chronocort for adults. The cortisol replacement market is for conditions that need life-long treatments, and has a potential value of $3.5bn. This is not adequately reflected in the valuation – DCF or peer group analysis.