Agreement to Progress Rare Disease Development in China

Pharmaceutical companies Diurnal Group and Citrine Medicine (China) have established a licencing agreement for Diurnal’s Alkindi® (hydrocortisone granules in capsules for opening) covering China, Hong Kong, Taiwan and Macau.

 Under the terms of the licence agreement Cardiff-based Diurnal, targeting patient needs in chronic endocrine (hormonal) conditions, receives an upfront payment of $0.5 million and $12.75m in additional cash payments arising from certain regulatory and sales milestones, as well as  tiered royalties on sales ranging from low to mid double-digits.

Citrine, co-founded by Vivo Capital, F-Prime Capital and Eight Roads Ventures, is focused on creating a therapeutic platform to deliver rare disease drugs to the Chinese market and to develop the first ever rare disease ecosystem in the country.

 It will be responsible for obtaining registration for Alkindi® as a treatment for paediatric patients in China and for all commercialisation activities, including pricing and reimbursement. Initially utilising the product from Diurnal’s European supply chain, it has an option to establish its own supply chain in China in the future. It is estimated that congenital adrenal hyperplasia (CAH) occurs in 1 in 6,084 births in China1. CAH is a group of genetic conditions that limit hormone production in the adrenal glands and was identified a rare disease by the Chinese health authorities in May 2018.

 Martin Whitaker, CEO of Diurnal, commented:

“With the increased focus from the Chinese health authorities on rare diseases in the past few years, we are delighted to have identified Citrine as a partner for Alkindi® in China. We have been impressed by Citrine’s vision for the creation of a rare disease platform in China and the local development, regulatory and commercialisation expertise they are able to bring to the programme. We believe they are well positioned to maximise the value of Alkindi® in this key market. If approved, Alkindi® will provide a major breakthrough in China as the only licensed treatment specifically designed for use in children with CAH, where there is a significant unmet patient need.”

 Melissa Bradford-Klug, Chief Business Officer of Citrine, commented:

“There are currently no drugs approved in China to treat pediatric patients with CAH, a disease of high unmet need. We are very excited about this partnership as it opens a path for us to bring an important new medicine to patients who need it and demonstrates the strong potential for cross-border collaborations to benefit patients with rare diseases worldwide. We look forward to continuing to work with biopharma companies across the US and Europe to bring additional rare disease medicines to China.”

More information online

 1 Zhong, K. et al. (2016) ‘The status of neonatal screening in China, 2013’, Journal of Medical Screening, 23(2), pp. 59–61. doi: 10.1177/0969141315597715.