Nxera Pharma Grants Synmosa Exclusive Rights to QUVIVIQ for Insomnia in Southeast Asia, Australia and New Zealand – Nxera Pharma
Nxera Pharma announces that its subsidiary, Nxera Pharma Japan, has entered into an exclusive license, supply and commercialization agreement (the “Agreement”) with Taiwan-headquartered Synmosa Biopharma Corporation (“Synmosa”) for Quviviq (daridorexant), a treatment for insomnia, in Singapore, Thailand, Indonesia, Malaysia, the Philippines, Vietnam, Australia and New Zealand (the “Territory”).
Under the Agreement, Nxera has granted Synmosa exclusive rights to submit regulatory applications for Quviviq, obtain and maintain the applicable regulatory approvals, and commercialize 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 authorization application is currently under review in South Korea. This new partnership announced today will advance regulatory approvals and commercialization in Southeast Asia, Australia and New Zealand, further expanding Nxera’s specialty pharmaceutical business in Japan and across the broader Asia-Pacific (“APAC”) region.
“We are delighted to partner with Synmosa and build the foundation for bringing Quviviq to patients across Southeast Asia, Australia and New Zealand. Insomnia is a serious yet under-recognized health burden that affects not only nighttime sleep but also daytime functioning. Synmosa brings extensive experience and a strong regional platform spanning regulatory affairs, market access, sales and distribution in the Asia-Pacific region, making it an important partner in maximizing the value of Quviviq in each of these markets. This agreement further advances our strategy to expand access to innovative specialty medicines across Japan and the wider APAC region.” – Christopher Cargill, President and CEO of Nxera Pharma.
“We thank Nxera for its trust and partnership. This agreement recognizes Synmosa’s regional capabilities and marks an important step in expanding our portfolio with Quviviq, an innovative treatment for insomnia. Through our established partner network and experience in regulatory affairs, market access and commercialization, we look forward to working with Nxera to bring this additional treatment option to patients across the Territory, subject to local regulatory approvals.” – Peter C. H. Lin, President of Synmosa.
