BLOCKSTONE study reaches primary endpoint of fewer people testing positive for the flu with fever and at least one respiratory symptom when treated with Xofluza versus placebo Xofluza may represent an important and convenient treatment for both reducing the burden of seasonal flu and limiting the impact of a pandemic South San Francisco CA -- September 1 2019 -- Genentech a member of the Roche Group SIX RO ROG OTCQX RHHBY today announced that the Phase III BLOCKSTONE study showed preventive treatment with Xofluza TM baloxavir marboxil after exposure to an infected household member significantly reduced the risk of people developing the flu by 86 percent versus placebo The results show just 19 percent of Xofluza-treated household members had the flu compared with 136 percent in the placebo-treated group p 00001 This benefit with Xofluza remained statistically significant versus placebo regardless of influenza A subtype H1N1 11 percent versus 106 percent p 00023 H3 28 percent versus 175 percent p 00001 It was also observed in household contacts who are at high risk of flu-associated complications 22 percent versus 154 percent p 00435 and children under 12 years of age 42 percent versus 155 percent p 00339 who are more vulnerable to developing the flu Xofluza had a comparable safety profile to placebo with an overall incidence of adverse events being 222 percent for Xofluza and 205 percent for placebo No serious adverse events were reported for Xofluza Full results of the study were presented as a late-breaking abstract during the OPTIONS X 2019 congress in Singapore on Sunday September 1 2019 Abstract 11718 As the influenza virus can rapidly infect those around us limiting the spread of infection within households potentially avoids a significant impact on the wider community a critical step in the global fight against the flu said Sandra Horning MD chief medical officer and head of Global Product Development We are encouraged by the BLOCKSTONE study the first to show that Xofluza is an effective preventive treatment following exposure to the flu and we look forward to sharing these data with health authorities The BLOCKSTONE study also demonstrated that even when fewer criteria were applied proportion of participants with the flu with fever or one or more respiratory symptoms there was still a significant 76 percent reduction in the risk of household members developing the flu with Xofluza versus placebo 53 percent versus 224 percent respectively p 00001 Xofluza is the first and only one-dose oral medicine approved to treat the flu in otherwise-healthy patients and the first flu medicine with a novel proposed mechanism of action approved by the FDA in nearly 20 years Robust clinical evidence has demonstrated the benefit of Xofluza in several populations otherwise-healthy high-risk children and treatment settings symptomatic flu post-exposure prophylaxis About BLOCKSTONE BLOCKSTONE is a Phase III randomized post-exposure prophylaxis study that evaluated a single dose of Xofluza compared with placebo as a preventive treatment for household members adults and children who are living with someone with an influenza infection confirmed by a rapid influenza diagnostic test the index patient The study was conducted by Shionogi Co Ltd during the 2018-2019 flu season in Japan Participants enrolled in the study were household members of someone who had been diagnosed with influenza The participants were randomized to receive a single dose of Xofluza dose according to body weight or placebo as a preventive measure against developing influenza The primary endpoint of the study was to evaluate the proportion of participants who tested positive for the influenza virus and had fever and one or more respiratory symptoms between day one and ten Secondary endpoints were clinical efficacy pharmacokinetics and safety and tolerability About Xofluza baloxavir marboxil Xofluza is a first-in-class one-dose oral medicine with a novel proposed mechanism of action that has demonstrated efficacy in a wide range of influenza viruses including in vitro activity against oseltamivir-resistant strains and avian strains H7N9 H5N1 in non-clinical studies Unlike other currently available antiviral treatments Xofluza is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein which is essential for viral replication Xofluza is currently approved in several countries for the treatment of influenza types A and B in children adolescents and adults and in the United States US for the treatment of acute uncomplicated influenza in people 12 years of age and older In addition a supplemental New Drug Application sNDA for Xofluza as a one-dose oral treatment for people at high risk of complications from the flu is under review by the FDA and a decision is expected by November 4 2019 Xofluza is being further studied in a Phase III development program including children under the age of one NCT03653364 severely ill hospitalized people with the flu NCT03684044 as well as to assess the potential to reduce transmission of the flu from an infected person to healthy people NCT03969212 Xofluza was discovered by Shionogi Co Ltd and is being further developed and commercialized globally in collaboration with the Roche Group which includes Genentech in the US and Shionogi Co Ltd Under the terms of this agreement Roche holds worldwide rights to Xofluza excluding Japan and Taiwan which will be retained exclusively by Shionogi Co Ltd XOFLUZA US Indication XOFLUZA is a prescription medicine used to treat the flu influenza in people 12 years of age and older who are otherwise healthy or at high risk of developing influenza-related complications who have had flu symptoms for no more than 48 hours It is not known if XOFLUZA is safe and effective in children younger than 12 years of age or weighing less than 88 pounds 40 kg Limitations of Use Influenza viruses change over time and factors such as the virus type or subtype emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA Important Safety Information Do not take XOFLUZA if you are allergic to baloxavir marboxil or any of the ingredients in XOFLUZA Before you take XOFLUZA tell your healthcare provider about all of your medical conditions including if you are pregnant or plan to become pregnant It is not known if XOFLUZA can harm your unborn baby are breastfeeding or plan to breastfeed It is not known if XOFLUZA passes into your breast milk Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines vitamins and herbal supplements Talk to your healthcare provider before you receive a live flu vaccine after taking XOFLUZA Take XOFLUZA with or without food Do not take XOFLUZA with dairy products calcium-fortified beverages laxatives antacids or oral supplements containing iron zinc selenium calcium or magnesium The most common side effects are diarrhea bronchitis nausea common cold symptoms nasopharyngitis and headache XOFLUZA is not effective in treating infections other than influenza Other kinds of infections can have symptoms like those of the flu or occur along with the flu and may need different kinds of treatment Tell your healthcare provider if you feel worse or develop new symptoms during or after treatment with XOFLUZA or if your flu symptoms do not start to get better