Viatris has completed the acquisition of Aculys Pharma.

晖致已完成对Aculys Pharma的收购。

The acquisition grants Viatris exclusive rights to develop and commercialise pitolisant and Spydia®, strengthening its Central Nervous System (CNS) portfolio in Japan and selected Asia-Pacific markets.

此次收购使Viatris获得了开发和商业化pitolisant和Spydia®的独家权利，加强了其在日本及部分亚太市场中的中枢神经系统（CNS）产品组合。

Pitolisant acts as a selective antagonist and inverse agonist of the histamine H3 receptor, which regulates sleep-wake cycles in the brain. The drug has received approvals from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy and EDS associated with OSAS.

Pitolisant 作为组胺 H3 受体的选择性拮抗剂和反向激动剂，该受体负责调节大脑中的睡眠-觉醒周期。该药物已获得欧洲药品管理局 (EMA) 和美国食品药品监督管理局 (FDA) 的批准，用于治疗与发作性睡病和 OSAS 相关的日间过度嗜睡 (EDS)。

By the end of 2023, pitolisant had been approved in 38 countries, including the U.S. and the EU, for narcolepsy, and in 29 EU countries for OSAS..

截至2023年底，pitolisant已在包括美国和欧盟在内的38个国家获批用于治疗嗜睡症，并在29个欧盟国家获批用于OSAS。

In June 2025, Spydia® Nasal Spray (5 mg, 7.5 mg, and 10 mg) received approval in Japan for treating status epilepticus in patients aged two years and above. It is the first intranasal anti-seizure treatment in Japan and the first rescue medication approved for out-of-hospital adult use.

2025年6月，Spydia®鼻喷雾剂（5毫克、7.5毫克和10毫克）在日本获得批准，用于治疗两岁及以上患者的癫痫持续状态。这是日本首个鼻内抗癫痫治疗药物，也是首个获准在医院外成人使用的急救药物。

Under the agreement, Viatris obtained exclusive development and commercialisation rights in Japan for pitolisant, a selective and inverse agonist of the histamine H3 receptor. Supported by positive Phase 3 trial outcomes in Japanese patients and global clinical data, Viatris plans to seek marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) by the end of 2025.

根据协议，Viatris 获得了选择性组胺 H3 受体逆向激动剂 pitolisant 在日本的独家开发和商业化权利。在针对日本患者的积极 3 期试验结果以及全球临床数据的支持下，Viatris 计划在 2025 年底前向日本厚生劳动省 (MHLW) 申请上市批准。

The submission will cover indications for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy, and for EDS associated with obstructive sleep apnoea syndrome (OSAS)..

该提交将涵盖成人嗜睡症的过度日间嗜睡（EDS）或猝倒症的适应症，以及与阻塞性睡眠呼吸暂停综合征（OSAS）相关的EDS。

The transaction also includes exclusive rights in Japan and certain Asia-Pacific countries for Spydia® Nasal Spray, which received Japanese regulatory approval in June 2025 for the treatment of status epilepticus.

该交易还包括Spydia®鼻喷雾剂在日本和某些亚太国家的独家权利，该产品于2025年6月获得日本监管机构批准用于治疗癫痫持续状态。

This acquisition enhances Viatris’ position in the Japanese market, complementing its existing portfolio of innovative therapies, including Effexor (generalised anxiety disorder), selatogrel (acute myocardial infarction), Nefecon (IgA nephropathy), cenerimod (systemic lupus erythematosus), and Tyrvaya (dry eye disease).

此次收购增强了 Viatris 在日本市场的地位，完善了其现有的创新疗法组合，包括 Effexor（广泛性焦虑症）、selatogrel（急性心肌梗死）、Nefecon（IgA 肾病）、cenerimod（系统性红斑狼疮）和 Tyrvaya（干眼症）。

Several of these candidates are currently in pivotal Phase 3 trials, with a Phase 3 trial for Tyrvaya expected to begin in 2026..

其中几种药物目前正处于关键的第三阶段试验，Tyrvaya的第三阶段试验预计将于2026年开始。

The acquisition reinforces Viatris’ commitment to advancing neurological care and expanding access to innovative CNS therapies across Asia.

此次收购加强了Viatris致力于推进神经科护理，并扩大亚洲地区获得创新中枢神经系统疗法的机会。

Source: prnewswire.com

来源：prnewswire.com