CAMBRIDGE, Mass. and SHANGHAI, Could 12, 2021 /PRNewswire/ — Citrine Medicine, a China-based uncommon illness therapeutics firm, right this moment introduced that it has signed a licensing settlement with Diurnal Group plc (AIM: DNL), a specialty pharmaceutical firm concentrating on affected person wants in continual endocrine (hormonal) ailments. The deal supplies Citrine with unique rights to develop and commercialize Efmody® (hydrocortisone modified-release onerous capsules – growth identify Chronocort®) within the Larger China market. In January, Citrine signed a licensing settlement with Dirunal Group for Alkindi,® the primary preparation of hydrocortisone particularly designed to be used in youngsters affected by pediatric adrenal insufficiency (AI) and congenital adrenal hyperplasia (CAH).
By licensing the rights to Efmody, Citrine strengthens its potential to supply therapies to sufferers in China with AI and CAH. With each Alkindi and Efmody as a part of its portfolio, Citrine now has the potential to assist the wants of pediatric, adolescent and grownup sufferers with these ailments. Efmody was developed to be used in grownup and adolescent sufferers with CAH and has been extensively studied in scientific trials throughout the U.S. and Europe. In March, the European Medicines Company issued a constructive opinion for Efmody. The formal approval of promoting authorization from the European Fee for Efmody is predicted in June 2021.
“We’re very excited to signal this second liscensing settlement with Diurnal, which can in the end enable us to serve the wants of Chinese language sufferers of all ages affected by AI and CAH,” mentioned Melissa Bradford-Klug, Chief Enterprise Officer of Citrine Drugs. “Citrine was based to supply people and households in China affected by uncommon ailments with the easiest therapies accessible on this planet, and this partnership brings us one step nearer to this aim.”
“This partnership highlights Citrine’s potential to deliver clinically-validated therapies developed and marketed in different elements of the world into China,” mentioned Dandan Dong, Managing Director, Vivo Capital. “Citrine is working to leverage its relationships with uncommon illness drug builders throughout the globe and with Chinese language regulatory our bodies to quickly deliver uncommon illness therapies to the sufferers in China who want them. Citrine is making vital strides in realizing its imaginative and prescient to construct a uncommon illness ecosystem in China.”
1 Zhong, Okay. et al. (2016) ‘The standing of neonatal screening in China, 2013′, Journal of Medical Screening, 23(2), pp. 59–61. doi: 10.1177/0969141315597715.
About Efmody® (hydrocortisone modified launch onerous capsules)
Efmody® is a preparation of hydrocortisone that has been particularly designed to imitate the circadian rhythm of cortisol when given in a twice-a-day ‘toothbrush’ routine (administered last item at evening earlier than sleep and very first thing within the morning on waking) to regulate androgen extra and continual fatigue in sufferers with ailments of cortisol deficiency. The primary indication for Efmody is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (youngsters older than 12 years of age). Efmody has been extensively studied in 239 human topics together with 138 CAH sufferers who’ve taken half in scientific trials in Europe and the U.S.
The constructive opinion from the CHMP is predicated on a Section 3 examine performed in a complete of 122 sufferers enrolled throughout 11 scientific websites, the most important ever interventional scientific trial accomplished in CAH. The Section 3 information was supported by detailed evaluation of knowledge from an open-label security extension examine for sufferers finishing remedy within the Section 3 examine, which is assessing the influence of remedy with Efmody over an prolonged interval, with plenty of sufferers on this trial having been handled for over 54 months. Affected person retention charges on this examine have been excessive and sufferers on this trial have, to this point, proven sustained profit from Efmody® remedy.
About Adrenal Insuffiency (AI) and Congenital Adrenal Hyperplasia (CAH)
AI, together with the genetic situation CAH, is a situation characterised by deficiency in cortisol, a necessary hormone in regulating metabolism and the response to emphasize. The first signs of AI are continual fatigue and sufferers are liable to adrenal disaster and loss of life if they don’t have enough cortisol alternative. AI is both major or secondary, with major AI ensuing from ailments intrinsic to the adrenal gland and secondary AI ensuing from pituitary ailments the place there’s a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone).
About Citrine Drugs
Citrine Drugs is devoted to enhancing the lives of sufferers with uncommon and intractable ailments by making prognosis and important therapies accessible and accessible to those that want them in China. Our mission is to construct the primary uncommon illness ecosystem in China and in doing so, allow extraordinary folks to stay extra unusual lives. Along with creating and advertising uncommon illness medication, Citrine goals to determine a patient-centric platform which educates folks on uncommon ailments, trains docs on prognosis and remedy, and helps docs develop a full illness administration protocol. Citrine is headquartered in Shanghai and has places of work in Beijing, China and Cambridge, Mass.
For extra info, go to citrinemed.com.
Finsbury Glover Hering
About Diurnal Group plc
Based in 2004, Diurnal is a UK-headquartered, European specialty pharma firm creating hormone therapeutics for the worldwide marketplace for the life-long remedy of continual endocrine situations, together with congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism.Its experience and revolutionary analysis actions deal with circadian-based endocrinology to yield novel product candidates within the uncommon and continual endocrine illness enviornment.
For additional details about Diurnal, please go to www.diurnal.co.uk
View unique content material to obtain multimedia:http://www.prnewswire.com/news-releases/citrine-medicine-announces-strategic-partnership-to-bring-efmody-to-china-for-use-in-adrenal-insufficiency-ai-including-congenital-adrenal-hyperplasia-cah-301289847.html
SOURCE Citrine Drugs