-- The European Commission (EC) has approved single-dose, oral Xofluza for 
      the treatment of uncomplicated influenza in patients aged 12 years and 
      above 
 
   -- The EC has also approved Xofluza for post-exposure prophylaxis of 
      influenza in individuals aged 12 years and above 
 
   -- Xofluza, with its rapid reduction in viral replication, could help 
      patients recover more quickly, while also reducing the societal burden of 
      influenza 
 
 
   Basel, 11 January 2021 -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today 
announced that the European Commission (EC) has approved Xofluza(R) 
(baloxavir marboxil) for the treatment of uncomplicated influenza in 
patients aged 12 years and above. In addition, the EC has approved 
Xofluza for post-exposure prophylaxis of influenza in individuals aged 
12 years and above. Post-exposure prophylaxis aims to prevent influenza 
in individuals following contact with someone infected with the 
influenza virus. The Commission's Decision follows the positive opinion 
received from the European Medicines Agency's Committee for Medicinal 
Products for Human Use in November, 2020, and is based on the results of 
the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.(1,2,3) This 
marks the first innovation in mechanism of action for an influenza 
antiviral approved by the EC in almost 20 years.(4) 
 
   "We are delighted that the European Commission has approved Xofluza, a 
first-in-class, single-dose oral medicine, for the treatment of 
influenza," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical 
Officer and Head of Global Product Development. "Xofluza offers patients 
the first novel mechanism of action for treating influenza approved in 
Europe in almost 20 years. With approval for both treatment and 
post-exposure prophylaxis, we are hopeful Xofluza will help patients 
recover more quickly while also reducing the societal burden of 
influenza, especially amid the COVID-19 pandemic." 
 
   Influenza is one of the most common, yet serious, infectious diseases, 
representing a significant threat to public health.(5,6) Globally, 
seasonal influenza epidemics result in three to five million cases of 
severe disease, millions of hospitalisations and up to 650,000 deaths 
every year.(7,8,9) The WHO estimates that up to 72,000 people in the 
Europe region die prematurely due to causes associated with influenza 
each year.(10) Antivirals are the only effective treatment specifically 
designed to target and treat the influenza virus, and their use shows a 
significant and sustained reduction in the use of key healthcare 
resources, providing a relief on healthcare costs.(11,12,13,14,15) 
 
   About CAPSTONE-1(1) 
 
   CAPSTONE-1 was a phase III multicentre, randomised, double-blind, 
placebo-controlled study that evaluated the efficacy and safety of 
Xofluza(R) (baloxavir marboxil) compared with placebo and oseltamivir in 
otherwise-healthy individuals with acute uncomplicated influenza, aged 
12 and above in the US and Japan. 
 
   The primary endpoint of the study was time to alleviation of symptoms. 
Xofluza significantly reduced the duration of influenza symptoms by more 
than one day compared with placebo (median time 53.7 hours versus 80.2 
hours; p<0.001). Similar efficacy results were seen between Xofluza and 
oseltamivir in relation to time to alleviation of symptoms (median time 
53.5 hours versus 53.8 hours). 
 
   Xofluza was well tolerated in this study and no new safety signals were 
identified. The study was conducted in the US and Japan by Shionogi & 
Co., Ltd. 
 
   About CAPSTONE-2(2) 
 
   CAPSTONE-2 was a phase III, multicentre, randomised, double-blind study 
that evaluated the efficacy and safety of single-dose of Xofluza(R) 
(baloxavir marboxil) compared with placebo and oseltamivir in 
individuals aged between 12 and 64 years, who were at high-risk of 
complications from influenza. The Centers for Disease Control and 
Prevention (CDC) defines people at high-risk for serious influenza 
complications to include adults 65 years of age or older, or those who 
have conditions such as asthma, chronic lung disease, morbid obesity, or 
heart disease. 
 
   The primary endpoint of the study was time to improvement of influenza 
symptoms. CAPSTONE-2 was the first prospective, controlled phase III 
clinical trial to demonstrate a significant and clinically meaningful 
benefit from an antiviral medicine in people at high-risk of serious 
influenza complications (median time to improvement in symptoms 73.2 
hours for Xofluza, 102.3 hours for placebo, p<0.0001). Similar median 
time to improvement in symptoms was seen between the Xofluza and 
oseltamivir groups (73.2 hours vs 81.0 hours, respectively). 
 
   Xofluza was well tolerated in this study and no new safety signals were 
identified. The study was conducted globally by Shionogi & Co., Ltd. 
 
   About BLOCKSTONE(3) 
 
   BLOCKSTONE was a phase III, double-blind, multicentre, randomised, 
placebo-controlled, post-exposure prophylaxis study that evaluated 
single-dose of Xofluza(R) (baloxavir marboxil) compared with placebo in 
household members (adults and children) who were living with someone 
with influenza confirmed by a rapid influenza diagnostic test (the 
'index patient'). 
 
   The primary endpoint of the study was the rate of laboratory-confirmed 
clinical influenza during the ten day period after receiving treatment. 
Xofluza showed a statistically significant prophylactic effect on 
influenza after a single oral dose, by reducing the risk of individuals 
aged 12 years and above from developing influenza after exposure to an 
infected household member, by 90% versus placebo. The proportion of 
household members aged 12 years and above who developed 
laboratory-confirmed clinical influenza was 1.3% in participants treated 
with Xofluza and 13.2% in the placebo-treated group. 
 
   Xofluza was well tolerated in this study and no new safety signals were 
identified. The study was conducted in Japan by Shionogi & Co., Ltd. 
 
   About Xofluza(R) (baloxavir marboxil) 
 
   Xofluza is a first-in-class, single-dose oral medicine with an 
innovative 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.(16,17,18) Xofluza is the first in a class of 
antivirals designed to inhibit the cap-dependent endonuclease protein, 
which is essential for viral replication.(1,19) 
 
   Xofluza is available in more than 30 countries for the treatment of 
influenza types A and B. In the US, Xofluza is approved for the 
treatment of acute, uncomplicated influenza in patients aged 12 years 
and above who are otherwise-healthy or at high-risk of developing 
serious complications from influenza, and who have been symptomatic for 
no more than 48 hours. Xofluza is also approved for post-exposure 
prophylaxis of influenza in individuals 12 years of age and older. 
Xofluza was the first new antiviral to be approved by the FDA in 20 
years, and is the first innovation in mechanism of action for an 
influenza antiviral approved by the EC in almost 20 years.(4) 
 
   Robust clinical evidence has demonstrated the benefit of Xofluza in 
several populations (otherwise-healthy, high-risk and post-exposure 
prophylaxis in individuals aged 12 years and above). Xofluza is being 
further studied in a phase III development programme, including children 
under the age of one (NCT03653364) as well as to assess the potential to 
reduce transmission of influenza from an infected person to healthy 
people (NCT03969212).(1,2,3,20) 
 
   Xofluza was discovered by Shionogi & Co., Ltd. and is being further 
developed and commercialised 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. 
 
   About Roche in Influenza 
 
   Influenza is one of the most common, yet serious, infectious diseases, 
representing a significant threat to public health. Globally, seasonal 
epidemics result in three to five million cases of severe disease, 
millions of hospitalisations and up to 650,000 deaths every year.(7,8,9) 
Roche has a long heritage in developing medicines that contribute to 
public health. We are committed to bringing innovation in the field of 
infectious diseases, including influenza. Tamiflu(R) (oseltamivir) has 
made a significant difference both to the treatment of seasonal 
influenza as well as in the management of recent pandemics, and we are 
proud to have brought this innovative medicine to patients. Although 
vaccines are an important first line of defence in preventing influenza, 
there is a need for new medical options for prevention (prophylaxis) and 
treatment. Roche is committed to addressing the unmet need in this area 
through its agreement with Shionogi & Co., Ltd. to develop and 
commercialise Xofluza. 
 
   About Roche 
 
   Roche is a global pioneer in pharmaceuticals and diagnostics focused on 
advancing science to improve people's lives. The combined strengths of 
pharmaceuticals and diagnostics under one roof have made Roche the 
leader in personalised healthcare -- a strategy that aims to fit the 
right treatment to each patient in the best way possible. 
 
 
 
   Roche is the world's largest biotech company, with truly differentiated 
medicines in oncology, immunology, infectious diseases, ophthalmology 
and diseases of the central nervous system. Roche is also the world 
leader in in vitro diagnostics and tissue-based cancer diagnostics, and 
a frontrunner in diabetes management. 
 
 
 
   Founded in 1896, Roche continues to search for better ways to prevent, 
diagnose and treat diseases and make a sustainable contribution to 
society. The company also aims to improve patient access to medical 
innovations by working with all relevant stakeholders. More than thirty

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