Nxera Pharma Enters New Commercial Partnership with Shionogi for QUVIVIQ™ in Japan

• QUVIVIQ™ is a potential best-in-class treatment in the high-growth, dual orexin antagonist class of medicines treating sleep disorders, such as insomnia

Tokyo, Japan and Cambridge, UK, 1 October 2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – announces that Nxera Pharma Japan Co., Ltd. (“NPJ”) has entered a new commercial partnership agreement with Shionogi & Co., Ltd. (“Shionogi”), regarding the distribution and sales for QUVIVIQ™ (daridorexant 25 and 50 mg) in Japan. At the same time, the previous commercialization arrangement between NPJ and Mochida Pharmaceutical Co., Ltd. (“Mochida”) has been terminated. After negotiation between Shionogi and Mochida, Shionogi will be solely responsible for distribution and sales activities in Japan.

QUVIVIQ™ is a novel dual orexin receptor antagonist, discovered by Idorsia Pharmaceuticals Ltd, that was approved by the Ministry of Health, Labour and Welfare of Japan (“MHLW”) for the treatment of adult patients with insomnia on 24 September 2024 (click for announcement).

Under the terms of the new agreement, Nxera will be responsible for providing drug product for the Japanese market, and Shionogi will be exclusively responsible for distribution and sales in Japan. Nxera will receive an upfront payment and is eligible to receive royalties on net sales from Shionogi. Mochida Pharmaceutical Factory Co., Ltd., a Mochida’s subsidiary, will remain exclusively responsible for manufacturing of QUVIVIQ™ in Japan. Upon the termination of the commercial agreement with Mochida, Nxera will make a one-off payment to Mochida.

Chris Cargill, President and CEO of Nxera Pharma, commented: “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. 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. We will work together with Shionogi and Mochida to prepare for the launch of this innovative product for patients who suffer from insomnia as quickly as possible.”

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About QUVIVIQ™

QUVIVIQ™ (daridorexant) is a dual orexin receptor antagonist, 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 a New Drug Application was submitted in Japan in October 2023. Daridorexant is approved in the US and Europe and marketed in these territories under the brand name QUVIVIQ™ by Idorsia Pharmaceuticals Ltd. Nxera Pharma has the Japanese and APAC (ex-China) 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 Pharmaceutical Co. Ltd.

* QUVIVIQ™ is a trademark of Idorsia Ltd.

About Shionogi & Co. Ltd.

Shionogi & Co., Ltd. is a leading global research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of “Supplying the best possible medicine to protect the health and well-being of the patients we serve.” Shionogi has discovered and developed novel antibiotics, medicines for HIV and influenza and currently markets medicines for infectious diseases and central nervous system disorders. Shionogi’s global pipeline includes research programs in infectious disease, pain/CNS, metabolic disorders, rare disease, oncology and stroke.

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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).

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Nxera – Media and Investor Relations

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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.