Nxera Pharma has announced that its subsidiary, Nxera Pharma Japan has entered into an exclusive license, supply and commercialisation agreement with Taiwan-headquartered Synmosa Biopharma Corporation for QUVIVIQ® (daridorexant), a treatment for insomnia, in Singapore, Thailand, Indonesia, Malaysia, the Philippines, Vietnam, Australia and New Zealand.
Under the Agreement, Nxera has granted Synmosa exclusive rights to submit regulatory applications for QUVIVIQ®, obtain and maintain the applicable regulatory approvals, and commercialise the product in the Territory. Synmosa will lead regulatory affairs, market access, marketing, distribution and sales in each country, while Nxera will be responsible for product supply and any necessary regulatory support.
In consideration for the rights granted under the Agreement, Nxera will receive an upfront payment and will be eligible to receive regulatory approval milestone payments, royalties based on sales and revenue from the supply of drug product.
Discovered and developed by Idorsia Pharmaceuticals, QUVIVIQ® is a dual orexin receptor antagonist (DORA) that blocks the binding of orexin, a wake-promoting neuropeptide, to orexin receptors 1 and 2 (OX1R and OX2R). In Japan, it is marketed under the brand name QUVIVIQ® Tablets for the treatment of insomnia in adults.
It has also been approved in Taiwan, and a marketing authorisation application is currently under review in South Korea. This new partnership will advance regulatory approvals and commercialisation in Southeast Asia, Australia and New Zealand, further expanding Nxera’s specialty pharmaceutical business in Japan and across the broader Asia-Pacific (APAC) region.
