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Shionogi Announces Positive Top-Line Results for Baloxavir Marboxil Phase III Study (CAPSTONE-2) in Individuals at High Risk for Influenza-Related Complications OSAKA, Japan, July 17, 2018 - Shionogi & Co., Ltd. (hereafter "Shionogi") has announced that the global phase III study (CAPSTONE-2) assessing baloxavir marboxil in individuals at high risk for influenza-related complications met the study's primary objective and showed superior efficacy in the primary endopoint of time to improvement of influenza symptoms compared with placebo. Baloxavir marboxil also demonstrated superior efficacy compared with placebo and compared with oseltamivir in key secondary endpoints, including reducing the time that the virus was 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. The results from the CAPSTONE-2 study will be presented at upcoming medical meetings. Baloxavir marboxil has a novel mechanism of action that inhibits cap-dependent endonuclease, an essential enzyme for viral replication. Baloxavir marboxil has already demonstrated a clinically significant benefit over both placebo and oseltamivir in the global phase III study in otherwise healthy patients (CAPSTONE-1). 1, 2 Baloxavir marboxil was approved in Japan on February 23, 2018 and is available under the brand name XOFLUZA® for the treatment of influenza Types A and B in adults and pediatric patients.3 Shionogi submitted the New Drug Application (NDA) for baloxavir marboxil in U.S. on April 24, 2018 for the treatment of acute uncomplicated influenza in patients 12 years of age and older and the U.S. Food and Drug Administration (FDA) recently accepted the NDA and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) date for an FDA decision is December 24, 2018.4 Shionogi submitted a NDA for baloxavir marboxil in Taiwan on June 29, 2018, for the treatment of influenza in patients 12 years of age and older. 5 The data from the CAPSTONE-2 study demonstrate that baloxavir marboxil provides a clinically meaningful benefit for patients who are most susceptible to influenza-related complications. There are no medicines which have demonstrated clear benefit specifically in high-risk populations in clinical studies. "Following the successful Phase III study reported previously in otherwise healthy patients, this study showed a positive result in high risk patients, including those with asthma or chronic lung disease, endocrine disorders, heart disease, metabolic disorders and morbid obesity or those who are 65 years of age or older, who tend to develop complications with influenza. We believe that baloxavir marboxil has the potential to offer an improved treatment for influenza for a wider patient population." said Dr. Tsutae Den Nagata, Chief Medical Officer.