Phase III CAPSTONE-2 study showed that baloxavir marboxil reduced symptoms in people at high risk of complications from the flu

F. Hoffmann-La Roche Ltd / Phase III CAPSTONE-2 study showed that baloxavir marboxil reduced symptoms in people at high risk of complications from the flu . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Baloxavir marboxil - an investigational oral, single-dose antiviral - is the first flu medicine with a novel proposed mechanism of action in nearly 20 years and to demonstrate significant efficacy in high-risk patients

Influenza, or "flu," represents a serious threat to public health - globally, annual epidemics result in 3 to 5 million cases of severe disease, millions of hospitalisations and up to 650,000 deaths worldwide ^{[1], [2], [3], [4], [5]}

Basel, 17 July 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study's primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo The Centers for Disease Control and Prevention (CDC)  defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes, or heart disease - for these people, flu can lead to hospitalisation or even death.^[6],  Baloxavir marboxil also demonstrated superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body. Furthermore, baloxavir marboxil significantly reduced the incidence of influenza-related complications compared to placebo. Baloxavir marboxil was well tolerated and no safety signals were identified. Full results from the CAPSTONE-2 study will be presented at upcoming medical meetings. Baloxavir marboxil was discovered and developed by Shionogi & Co., Ltd., and is sold in Japan under the trade name Xofluza®.