# Diurnal Group Chronocort – seeking regulatory advice

- Link: https://www.directorstalkinterviews.com/diurnal-group-chronocort-seeking-regulatory-advice/412764301
- Published: 2019-01-16T07:37:21+00:00
- Author: Charlotte Edwards

**[⌊Hardman & Co Report Report Downloads⌉⌊Hardman & Co Report Report Downloads⌉[Diurnal Group**(
LON:DNL) is a commercial-stage specialty pharmaceutical company focused on diseases
of the endocrine system. Its two lead products target rare conditions where medical
needs are currently unmet, with the aim of building a long-term ‘Adrenal Franchise’.
Alkindi is being launched in key EU markets, and this was expected to be followed
by Chronocort; however, headline data from its EU Phase III trial in CAH did not
show superiority over standard-of-care, thereby failing to meet its primary end-
point. DNL is seeking ‘Scientific Advice’ from the EMA about how to proceed, which
should be available in 2Q’19, with a view to filing for market authorisation in 
Europe.

**Strategy:** DNL’s strategic goal is to create a valuable ‘Adrenal Franchise’ that
can treat patients with chronic cortisol deficiency diseases from birth and for 
the rest of their lives. The long-term vision, once Alkindi and Chronocort are established
in Europe and the US, is to expand the product offering to other endocrine conditions.

**Phase III results:** The full data set has now been analysed and despite not meeting
its primary end-point of superiority, Chronocort was seen as efficacious and conferring
many advantages over standard-of-care, such as improved androgen control in the 
critical morning period and lower levels of androgen over 24 hours.

**EMA Scientific Advice:** A briefing package for Chronocort requesting ‘Scientific
Advice’ has been submitted to the EMA. It includes additional analysis from the 
trial and the Phase III safety extension currently running, showing the benefits
of Chronocort. The meeting is expected to take place in 1Q’19, with feedback in 
2Q’19.

**Risks**: While there is a risk with all drugs in development that they might fail
clinical trials or not be approved, DNL had been considered to have unusually low
risk, as its products are formulations of well-established drugs. Following Alkindi’s
approval in Europe, the Chronocort outcome was unexpected.

**Investment summary**: Alkindi, a cortisol replacement therapy designed for babies
and children, is DNL’s first product on the market. It had been expected to be followed
by Chronocort for adults – a much larger market. The fall in the share price following
this unpredictable outcome looks overdone, but the price is likely to languish in
the short term until there is clarity from the regulators about how to move Chronocort
forward (in 2Q’19).

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