US FDA approves XOFLUZA (Baloxavir Marboxil) new drug to treat influenza on 24 th Oct 2018

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1 US FDA approves XOFLUZA (Baloxavir Marboxil) new drug to treat influenza on 24 th Oct 2018

2 Influenza Disease Burden What is Influenza? Facts and Figures (1) A common viral infection that can be deadly, especially in highrisk groups and it is also termed as Flu The flu attacks the lungs, nose and throat. Signs and Symptoms: CDC says as many as 646,000 people may die from influenza each year worldwide. The H3N2 strain is the most common form of the flu virus. The Spanish flu pandemic of 1918, the deadliest in history. Source:

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4 About XOFLUZA (Baloxavir Marboxil) (1) About the Genetech and Roche About Genentech: Is a leading biotechnology company 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 U.S.) 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 will also be further studied in a Phase III development program including pediatric populations, post-exposure prophylaxis and severely ill hospitalized people with influenza, as well as to assess the potential to reduce transmission in otherwise healthy people. Brief on Xofluza XOFLUZATM is a polymerase acidic (PA) endonuclease inhibitor indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. DOSAGE AND ADMINISTRATION: Take a single dose of XOFLUZA orally within 48 hours of symptom onset with or without food. Avoid co-administration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cationcontaining laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc). The dose of XOFLUZA depends on weight. DOSAGE FORMS AND STRENGTHS: Tablets: 20 mg and 40 mg ADVERSE REACTIONS: diarrhea (3%), bronchitis (2%), nasopharyngitis (1%), headache (1%) and nausea (1%). USE IN SPECIFIC POPULATIONS: Safety and efficacy in patients less than 12 years of age or weighing less than 40 kg have not been established Sourcehttps://

5 About XOFLUZA (Baloxavir Marboxil) (2) Product information Mechanism of action. DRUG INTERACTIONS: Avoid co-administration of XOFLUZA with polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc). Live attenuated influenza vaccines may be affected by antivirals Source

6 Market Overview Influenza Current Treatment options Antiviral medications such as: oseltamivir (Tamiflu) or zanamivir (Relenza) Drink plenty of liquids Rest Pain Relievers: Acetaminophen or Ibuprofen Top Competitive landscape for Xofluza Xofluza s major competitor in the flu market will be Tamiflu

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