Nxera Pharma Co Ltd has announced a new commercial partnership agreement with Shionogi & Co Ltd for the distribution and sales of Quviviq (daridorexant 25 and 50 mg) in Japan, following its approval for treating adult patients with insomnia. This move follows the termination of the previous commercialization arrangement between Nxera Pharma Japan Co Ltd and Mochida Pharmaceutical Co Ltd. Shionogi will now assume full responsibility for sales and distribution activities in Japan.
Regulatory Approval and Clinical Data
Quviviq, a novel dual orexin receptor antagonist discovered by Idorsia Pharmaceuticals Ltd, received approval from the Ministry of Health, Labour, and Welfare of Japan in September. The approval was based on robust clinical efficacy and safety data, including a Phase 3 trial in Japan. The Phase 3 study demonstrated statistically significant improvements in subjective Total Sleep Time (TST) and Latency to Sleep Onset (sLSO) compared to placebo (p<0.001 for 50 mg, p=0.042 for 25 mg for TST; p<0.001 for 50 mg, p=0.006 for 25 mg for sLSO).
Commercial Agreement Details
Under the terms of the new agreement, Nxera will be responsible for providing the drug product for the Japanese market, while Shionogi will handle exclusive distribution and sales. Nxera will receive an upfront payment and is eligible for royalties on net sales from Shionogi. Mochida Pharmaceutical Factory Co, Ltd, a subsidiary of Mochida, will continue to manufacture Quviviq in Japan. Nxera will make a one-off payment to Mochida upon the termination of their commercial agreement.
Impact on Insomnia Treatment in Japan
Insomnia is highly prevalent in Japan, affecting approximately 20% of Japanese adults, and is recognized as a significant national issue impacting both physical and mental health. According to Makoto Uchiyama, M.D., Ph.D., medical advisor of the Japanese Phase 3 study, Quviviq is the first drug in a decade clinically investigated in over 100 centers in Japan to show increased total sleep time and shortened sleep latency without marked hangover symptoms the next morning.
Statements from Leadership
Chris Cargill, president and CEO of Nxera Pharma, stated, "Quviviq has the potential to become a significant product for Nxera Pharma in Japan. Through its novel mechanism of action, it could provide a best-in-class treatment option to address a major national health issue that affects millions of individuals in Japan who suffer from insomnia." He added, "In Shionogi, we have secured a sales partner with the scale and expertise to rapidly address the full market opportunity and reach healthcare professionals and insomnia patients across the country."
About Quviviq
QUVIVIQ (daridorexant) is a dual orexin receptor antagonist that blocks the binding and activity of orexins, wake-promoting neuropeptides. It is approved in the US and Europe and marketed by Idorsia Pharmaceuticals Ltd. Nxera Pharma holds the Japanese and APAC rights for daridorexant following its acquisition of Idorsia Pharmaceuticals Japan Ltd and Idorsia Pharmaceuticals Korea Co Ltd in 2023. Quviviq was co-developed in Japan by Nxera and Mochida.
