Citrine Medicine Announces Strategic Partnership to bring Alkindi® to China for Use in Pediatric Congenital Adrenal Hyperplasia (CAH)
Citrine Medicine, a China-based rare disease therapeutics company, today announced that it has entered into a licensing agreement with Diurnal Group plc (AIM: DNL), a specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases. The deal provides Citrine with exclusive rights to develop, register and commercialize Alkindi® in the Greater China market.
Citrine is a therapeutics company building the first rare disease ecosystem in China by in-licensing clinically validated assets developed in the U.S. and Europe. Citrine is leveraging China’s expedited regulatory pathways to achieve rapid approval of rare disease drugs. They are also building an integrated platform that can support scalable commercialization via key opinion leader engagement, diagnosis and treatment of rare diseases patients, disease advocacy, and patient financial support. Citrine is initially focused on rare diseases in neurology, hepatology, nephrology, endocrine, metabolic and pediatric oncology.
By licensing the rights to Alkindi®, Citrine aims to bring the first clinically validated pediatric treatment for congenital adrenal hyperplasia (CAH), a group of genetic conditions that limit hormone production in the adrenal glands, to China. It is estimated that CAH occurs in 1 in 6,084 births in China. CAH was identified as a rare disease by the Chinese health authorities in May 2018.
“There are currently no drugs approved in China to treat pediatric patients with CAH, a disease of high unmet need,” said Melissa Bradford-Klug, Chief Business Officer of Citrine. “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 U.S. and Europe to bring additional rare disease medicines to China.”
About Alkindi® (hydrocortisone granules in capsules for opening)
Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from pediatric adrenal insufficiency (AI). Alkindi® is a patented, oral, immediate-release pediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from diseases due to cortisol deficiency including pediatric AI and congenital adrenal hyperplasia (CAH). AI requires life-long treatment and Diurnal’s novel approach to product development has the potential to significantly improve these young patients’ lives. The European Commission has granted a pediatric use marketing authorization (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi® is approved and known as Alkindi® Sprinkle in the US where it is licensed and marketed by Eton Pharmaceuticals. Alkindi® is also approved in Israel and Australia.
About Pediatric Adrenal Insufficiency and Congenital Adrenal Hyperplasia
Pediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone).
About Citrine Medicine
Citrine Medicine is dedicated to improving the lives of patients with rare and intractable diseases by making diagnosis and essential treatments available and accessible to those who need them in China. Our mission is to build the first rare disease ecosystem in China and in doing so, enable extraordinary people to live more ordinary lives. In addition to developing and marketing rare disease drugs, Citrine aims to establish a patient-centric platform which educates people on rare diseases, trains doctors on diagnosis and treatment, and helps doctors develop a full disease management protocol. Citrine is headquartered in Shanghai and has offices in Beijing, China and Cambridge, Mass.
Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.
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