Tokyo, Japan and Cambridge, UK, 19 December 2024 - Nxera Pharma Co., Ltd. ("Nxera” or "the Company”; TSE 4565) - formerly known as Sosei Group or Sosei Heptares - and Shionogi & Co., Ltd. ("Shionogi”) today announce that QUVIVIQ™ (daridorexant) 25 and 50 mg has been launched and is now available in Japan as a new treatment for adults with insomnia.
QUVIVIQ™ is an oral Dual Orexin Receptor Antagonist (DORA) for the treatment of insomnia that selectively binds to receptors of the wake-promoting neuropeptide orexin (OX1R and OX2R), inhibiting excessive wakefulness and facilitating the transition to sleep.
Nxera Pharma Japan Co., Ltd. (a wholly owned subsidiary of Nxera Pharma) is the approval holder and will be responsible in part for provision of drug product. Shionogi will be solely responsible for distribution and sales activities for QUVIVIQ™ in Japan under the commercial partnership agreement with Nxera Pharma announced on 1 October 2024.
For Nxera, reaching this important milestone highlights its ability to develop novel therapeutics for patients in Japan and reinforces its ambition to be a partner of choice for companies looking to develop and commercialize new therapeutics for the Japanese market.
As a new pillar, Shionogi is focusing on the 'QOL disease area,' which is less affected by trends. Starting with the launch of QUVIVIQ™, Shionogi is working to strengthen the 'QOL disease area' as a solid pillar.
Together, Nxera and Shionogi are committed to deliver QUVIVIQ™ as quickly as possible as a product that has the potential to meet the needs of insomnia patients for a long time to come.
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Notes to Editors
Product Information
| Product name | QUVIVIQ™ 25 mg, 50 mg |
| Non-proprietary name | daridorexant |
| Indication | Insomnia |
| Dosage regimen | The usual adult dosage is 50 mg of daridorexant to be taken orally once daily immediately before bedtime. In addition, depending on the patient's condition, 25 mg can be administered once daily. |
| Date of approval | 24 September 2024 |
| Date of NHI price listing | 20 November 2024 |
| Date of launch | 19 December 2024 |
| Drug price | JPY57.30 per 25 mg tablet JPY90.80 per 50 mg tablet |
| Approval holder | Nxera Pharma Japan Co., Ltd. |
| Distributor | Shionogi & Co., Ltd. |
QUVIVIQ™ (daridorexant) is a dual orexin receptor antagonist, discovered by Idorsia Pharmaceuticals Ltd, that blocks the binding and activity of the wake-promoting neuropeptides known as orexins. In October 2022, daridorexant achieved positive Phase 3 top-line results in Japanese patients with insomnia and Nxera Pharma Japan has obtained the manufacturing and marketing approval in Japan for QUVIVIQ™ as a treatment for adult patients with insomnia, as of September 24, 2024. Daridorexant is approved in the US, Europe and Canada, and marketed in these territories under the brand name QUVIVIQ™ by Idorsia Pharmaceuticals Ltd.
* QUVIVIQ™ is a trademark of Idorsia Ltd.
About Insomnia Disorder
Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. As defined this impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep.
Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. According to a survey by Japan's Ministry of Health, Labour and Welfare in 2018, about 20% of Japanese adults struggle to get enough rest from sleep.
Insomnia as a disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels.
The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy.
About Shionogi
Shionogi strives constantly to supply the best possible medicine (healthcare solutions) to protect the health and wellbeing of the patients we serve, and as a united group. We have identified Contributing to a Healthy and Prosperous Life as a material focus. We are committed to creating a society where everyone can lead a longer, more vibrant life, realizing their goals.
For more information, please visit https://www.shionogi.com/global/en/
About Nxera Pharma
Nxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally.
In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery NxWave™ platform to provide a sustainable source of best- or first-in-class candidates.
Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565).
For more information, please visit www.nxera.life
LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma
Enquiries:
Nxera - Media and Investor Relations
Kentaro Tahara, VP Investor Relations and Corporate Strategy
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
Maya Bennison, Communications Manager
+81 (0)3 5210 3399 | +44 (0)1223 949390 |[email protected]
MEDiSTRAVA (for International Media)
Mark Swallow, Frazer Hall, Erica Hollingsworth
+44 (0)203 928 6900 | [email protected]
Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group's actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
