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Eurofarma announces strategic alliance with Eisai for the commercialization of DAYVIGO(R) in Brazil. Innovative medicine with a novel mechanism of action to enter the Brazilian market this year marking a new era in insomnia treatment Published in: August 17, 2026 and updated in: August 18, 2026 * To share Listen to the text São Paulo, August 17th de 2026 - Eurofarma and Eisai Laboratórios Ltda. ("Eisai") today announced a strategic alliance for the commercialization of DAYVIGO(R)(lemborexant), an innovative medicine indicated for the treatment of insomnia in adults and the first dual orexin receptor antagonist (DORA) approved in Brazil. The medicine has demonstrated consistent efficacy in sleep onset and maintenance across objective and patient-reported measures, with robust evidence of promoting a transition to sleep that more closely resembles the natural sleep pattern, with no evidence of risk of dependence.[1-3] Under the terms of the agreement, Eurofarma will be responsible for the commercialization, promotion, and distribution of DAYVIGO(R) throughout the country. Eisai will remain responsible for the product's marketing authorization and defining the brand's overall strategy in Brazil. The collaboration combines Eisai's global expertise in sleep medicine and central nervous system disorders with Eurofarma's extensive commercial reach, strong local market presence, and expertise in the central nervous system area, helping expand access to innovative treatment options for people living with insomnia. Insomnia is characterized by difficulty falling asleep, staying asleep, or both despite an adequate opportunity to sleep. When it occurs at least three times per week for a minimum period of one months, it may lead to fatigue, difficulty concentrating, and irritability[4,5]. The prevalence of insomnia disorder among adults in Brazil is estimated at approximately 15%[6], representing around 24 million adults living with the condition. Currently, the most commonly prescribed medications for insomnia in the country act directly by inducing drowsiness, and there is growing demand for new therapeutic options. "At Eurofarma, we continuously seek to identify and provide innovations capable of transforming people's lives. This partnership reinforces our strategy of connecting patients with differentiated, high-impact therapies, helping to raise the standard of care in areas with significant unmet medical needs", said João Siffert, Vice President of Innovation, Eurofarma. "This collaboration represents more than a commercial agreement; it reflects a shared commitment to addressing unmet medical needs in Brazil. By combining Eisai's scientific leadership in neuroscience with Eurofarma's extensive market expertise, we are expanding access to innovative therapies for people living with insomnia. Together, we are creating value for patients, healthcare professionals, and society", said Priscila Cavalcante, Commercial Director at Eisai. About DAYVIGO(R)(Lemborexant) DAYVIGO(R), an orexin receptor antagonist, is Eisai's in-house discovered and developed small molecule and has been approved by the Brazilian Health Regulatory Agency (Anvisa) for the treatment of insomnia in adults characterized by difficulty initiating and/or maintaining sleep. It is a small molecule that inhibits orexin neurotransmission by competitively binding to both orexin receptor subtypes (orexin receptor 1 and orexin receptor 2)[8]. Its rapid association with and dissociation from orexin receptors may help improve both sleep onset and sleep maintenance[9]. The product has already been approved for the treatment of insomnia in more than 28 countries, including Japan, the United States, Canada, Australia, and several countries across Asia[10]. In randomized studies using both objective and subjective assessments, individuals treated with lemborexant demonstrated improvements in sleep parameters compared with placebo, including reduced sleep onset latency, increased sleep duration, and improved sleep efficiency. Efficacy and tolerability have also been shown to be maintained over 12 months of treatment. Furthermore, no evidence of rebound insomnia or withdrawal symptoms was observed following treatment discontinuation[3,6,11,12]. Studies conducted in both adults and older adults have also shown that lemborexant is not associated with clinically relevant residual morning effects, such as impaired postural stability upon awakening or reduced driving performance the next morning. Additionally, the medicine did not impair the ability to awaken in response to auditory stimuli[11-13]. The arrival of DAYVIGO(R) in the Brazilian market symbolizes a paradigm shift in a therapeutic area that has remained relatively stable for decades, representing one of the most significant recent innovations in sleep medicine. Referências 1. DRAGER, Luciano Ferreira et al. Consenso de diagnóstico e tratamento da insônia em adultos 2023. São Paulo: Segmento Farma Editores, 2023. Available at: Brazilian Insomnia Consensus. Accessed: January 20, 2026. 2. Kärppä M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020 Sep 14;43(9):zsaa123. 3. Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Network Open. 2019 Dec 2;2(12):e1918254. 4. Ferrie JE, et al. Sleep epidemiology: a rapidly growing field. International Journal of Epidemiology. 2011;40(6):1431-1437. 5. Roth T. Insomnia: definition, prevalence, etiology and consequences. Journal of Clinical Sleep Medicine. 2007;3(5 Suppl):S7-S10. 6. Castro LS, Poyares D, et al. Objective prevalence of insomnia in the São Paulo, Brazil epidemiologic sleep study. Annals of Neurology. 2013;74(4):537-546. 7. Internal estimate. 8. Muehlan C, et al. The orexin story and orexin receptor antagonists for the treatment of insomnia. Journal of Sleep Research. 2023 Dec;32(6):e13902. 9. Beuckmann CT, et al. In Vitro and In Silico Characterization of Lemborexant (E2006), a Novel Dual Orexin Receptor Antagonist. Journal of Pharmacology and Experimental Therapeutics. 2017 Aug;362(2):287-295. 10. Eisai Global. 2025. Eisai Launches In-House Developed Anti-Insomnia Drug DAYVIGO(R)(Lemborexant) in China. Available at: Eisai News Release. Last accessed: July 2026. 11. Murphy P, Kumar D, Zammit G, Rosenberg R, Moline M. Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakening. Journal of Clinical Sleep Medicine. 2020 May 15;16(5):765-773. 12. Gotfried MH, Auerbach SH, Dang-Vu TT, Mishima K, Kumar D, Moline M, Malhotra M. Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials. Drugs & Aging. 2024 Sep;41(9):741-752. 13. Vermeeren A, Jongen S, Murphy P, Moline M, Filippov G, Pinner K, Perdomo C, Landry I, Majid O, Van Oers ACM, Van Leeuwen CJ, Ramaekers JG, Vuurman EFPM. On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers. Sleep. 2019 Apr 1;42(4):zsy260. Erratum in: Sleep. 2020 Jul 13;43(7):zsaa068. About Eurofarma Founded in 1972, Eurofarma operates in the healthcare sector through the production and commercialization of products and services aimed at improving people's quality of life. Focused on generating shared value, the company operates across the main pharmaceutical segments, including prescription medicines, generics, hospital products, oncology, OTC medicines, personal care, and animal health, in addition to providing third-party manufacturing services. With broad therapeutic coverage, its portfolio includes more than 4,000 SKUs, serving virtually all medical specialties. The leader in prescription medicines in Brazil and the second-largest player in generics in the country, Eurofarma is present in 24 countries, with full coverage across Latin America and regional leadership in the retail market. The company also maintains operations in the United States and Africa, employs more than 13,000 people, and operated 10 manufacturing plants, producing 630 million units in 2025. In the same year, Eurofarma invested more than BRL 700 million in innovation projects and achieved net revenue exceeding BRL 12 billion. About Eisai Laboratórios Ltda. Founded in 2011 and headquartered in São Paulo, Eisai Laboratórios Ltda. is the Brazilian subsidiary of Eisai Co., Ltd., a global pharmaceutical company founded in Japan in 1941. The company is dedicated to improving the lives of patients and their families in Brazil by delivering innovative medicines that address significant unmet medical needs. Eisai's corporate concept is to give first thought to patients and people in the daily living domain, known as its human health care (hhc) concept. Guided by this philosophy, Eisai strives to create and deliver innovative medicines that address unmet medical needs, particularly in the strategic areas of Neurology and Oncology. Through its global network of research and development facilities, manufacturing sites and marketing subsidiaries, Eisai is committed to increasing the benefits that healthcare provides, relieving anxiety over health, and reducing health disparities around the world. Media Contact Eurofarma G&A Relações Públicas Iza França - 11 97644-4496 - [email protected] Guilherme Gaspar - 11 98285-6000 - [email protected] Murillo Israel - [email protected]

FDA approves Takeda's first-in-class narcolepsy drug. Key summary: * FDA clears first drug to treat the underlying cause of narcolepsy type 1. * Takeda forecasts peak annual sales of up to $5bn for Orzeyful. * Rivals including Alkermes, Eli Lilly and Eisai are racing to develop competing therapies. Takeda has secured FDA approval for the first drug to treat the underlying cause of narcolepsy type 1, with the company forecasting peak annual sales of between $2bn and $3bn as it seeks further regulatory approvals. Known as Orzeyful (oveporexton), the therapy is an orexin receptor 2 agonist that restores a brain signal missing in people with narcolepsy type 1. Unlike existing treatments, it targets the underlying cause of the disease rather than simply treating its symptoms. Narcolepsy is a chronic neurological disorder characterised by excessive daytime sleepiness, sudden muscle weakness known as cataplexy, sleep paralysis and vivid hallucinations. For now, Orzeyful is approved only for adults with narcolepsy type 1 in the US. Its safety and efficacy have not yet been established in people younger than 18 years in the country. Orzeyful's efficacy. The approval was backed by positive results from two pivotal clinical trials. In the FirstLight and RadiantLight studies, Orzeyful significantly improved patients' ability to stay awake compared with placebo. The therapy also reduced cataplexy, sleep paralysis, hallucinations and disrupted night-time sleep. The most common adverse events included insomnia, increased urinary frequency, urinary urgency and increased salivation. "The FDA approval of Orzeyful marks a new chapter for the narcolepsy type 1 community, as we introduce an entirely new class of medicine that will potentially redefine how this disease is managed and how people feel on treatment," said Julie Kim, President and Chief Executive Officer, Takeda. The company expects to launch Orzeyful in the US in November, subject to scheduling by the Drug Enforcement Administration. Further approvals. The FDA's decision follows Orzeyful's clearance in China last month for adults and adolescents aged 16 years and older. The therapy also remains under review in Japan, while Takeda plans to file for approval in Europe later this year. Although Takeda is first to market, competition is already building. Irish biopharmaceutical company Alkermes is progressing alixorexton through phase 3 trials, while Eli Lilly's cleminorexton and Eisai's ledasorexton are both in phase 2 development. Brain health company Lundbeck is also developing Lu AH69593, which is in phase 1b trials. Press play to listen to this content