Simcere Pharmaceuticals and Idorsia announced that they have entered into a licensing agreement in China for Idorsia’s QUVIVIQ (daridorexant), an orexin antagonist medication used for the treatment of insomnia.
“There are over 200 million people in China who suffer from chronic insomnia that may benefit from daridorexant. Patients are eager for a better treatment option that improves quality of sleep and next-day functioning. Simcere has a proven track record of successfully developing and marketing innovative central nervous system therapies in China. In collaboration with Idorsia, we hope to bring another impactful medicine to millions of people,” says Jinsheng Ren, chairman and CEO of Simcere, in a statement.
Under the agreement, Simcere will be granted an exclusive right to develop and commercialize daridorexant in Mainland China, Hong Kong, and Macau. Simcere will be responsible for the funding and conducting of a local development program with Chinese patients. Simcere successfully commercializes Sanbexin for acute ischemic stroke and daridorexant will expand Simcere’s pipeline of CNS products in China.
According to the terms of the agreement, Idorsia will receive a $ 30 million payment, and will be eligible to receive an additional milestone payment of $20 million upon regulatory approval by the National Medical Products Administration, as well as commercial milestone payments and low double-digit tiered royalties based upon future sales.
“Daridorexant is on track to becoming a global success, helping the millions of sufferers of insomnia around the world. Marketed as QUVIVIQ, we expect daridorexant will soon be the leading branded insomnia medication in the US in terms of new prescriptions. It is also the first dual orexin receptor antagonist available to patients in Europe, and recent positive data in Japan gives me confidence that we can make it available there too. We have been convinced of Simcere’s shared enthusiasm for daridorexant, and I am confident that they are the right partner to join us on our mission of bringing an optimal treatment approach to patients with insomnia around the world by developing and commercializing daridorexant in China,” says Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia, in a statement.
Idorsia’s research team has been working on the science of orexin and orexin receptors since they were first described in 1998. The team’s initial work led to the conclusion that antagonism of the orexin system was the key to preserving a natural sleep architecture for patients with insomnia. With this as the target, the team designed a dual antagonist with the goal of a rapid onset of effect and a duration of action sufficient to cover the night but short enough to avoid any negative next-morning residual activity at optimally effective doses.
Daridorexant is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins. Rather than inducing sleep through broad inhibition of brain activity, daridorexant blocks only the activation of orexin receptors. Consequently, daridorexant decreases the wake drive, allowing sleep to occur, without altering the proportion of sleep stages. The results of a Phase 3 clinical development program have been reported by Mignot, E., et al. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomized, double-blind, placebo-controlled, phase 3 trials, in The Lancet Neurology.