Citrine Medicine, a China-based rare disease therapeutics platform company, announced that it has entered into a development and licensing agreement with Bioprojet SCR (Bioprojet), a private French company focused on the design, synthesis and development of novel classes of drugs for unmet medical needs. The partnership provides Citrine with exclusive rights to develop, register, market, and manufacture Wakix® (pitolisant) in China for the treatment of narcolepsy and obstructive sleep apnea.
Pitolisant is a selective histamine H3-receptor antagonist/inverse agonist that enhances the activity of histaminergic neurons and was developed after decades of research by Bioprojet co-founders Dr. Jeanne-Marie (J.M.) Lecomte and Prof. Jean-Charles Schwartz. Pitolisant increases the release of the brain chemical histamine to increase a patient's wakefulness and alertness. It is approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) to treat adults suffering from narcolepsy, a serious, chronic disorder characterized by excessive daytime sleepiness (EDS), with or without cataplexy.
Currently no drugs have been officially approved by the National Medical Products Administration (NMPA) in China for the treatment of narcolepsy. There is a high unmet medical need for the treatment of narcolepsy patients with and without cataplexy in China.
"We believe Citrine is well positioned to build an ecosystem in China to support patients suffering from rare diseases. The partnership with Bioprojet represents the company’s first effort to bring in validated medicines for patients in need. We look forward to supporting Citrine in its continued efforts to strengthen its capabilities and pipeline, while accelerating rare and orphan disease drug development both in China and globally," she continued.
"We're excited that we are able to research, develop, and seek approval in China for Wakix®, a potential first-in-class therapy to treat patients with narcolepsy," said Citrine CEO, Ben Wu. "In addition to working with the NMPA, Citrine will be working closely with healthcare providers, advocacy organizations, and other stakeholders to help address the unmet needs of the patient community."
"Bioprojet is proud to partner with Citrine to help bring pitolisant to additional patients in need. With our collaborative best-in-class approach, we plan to help bring much needed relief to thousands of people suffering from debilitating sleep-related disorders,” said Prof. Schwartz, discoverer of the histaminergic neurotransmission in brain and of the H3 receptor. Prof. Schwartz is the co-founder of Bioprojet with Dr. J.M. Lecomte.