Market Overview

Phase III CAPSTONE-2 Study Showed That Baloxavir Marboxil Reduced Symptoms in People at High Risk of Complications From the Flu

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– 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
populations –

– 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 hospitalizations and up to 650,000 deaths worldwide

Genentech, a member of the Roche Group ((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, the flu can lead to hospitalization or even
death.

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®.

"Baloxavir marboxil is the first antiviral to show a clinically
meaningful benefit in people who are most susceptible to complications
from the flu, including older people and those living with certain
medical conditions," said Sandra Horning, M.D., chief medical officer
and head of Global Product Development. "We plan to submit the results
of this second positive Phase III study for baloxavir marboxil to
healthcare authorities, and look forward to discussing next steps since
there are no current antiviral medicines approved to specifically treat
this high-risk population."

Baloxavir marboxil has already demonstrated a clinically significant
benefit over placebo in otherwise healthy people in the Phase III
CAPSTONE-1 study. The U.S. Food and Drug Administration (FDA) recently
accepted a New Drug Application (NDA) and granted Priority Review to
baloxavir marboxil as a single-dose, oral treatment for acute,
uncomplicated influenza in people 12 years and older based on the
CAPSTONE-1 study and the Phase II study, and is expected to make a
decision on approval by December 24, 2018. If approved, baloxavir
marboxil would be the first single-dose oral antiviral, and the first
medicine with a novel proposed mechanism of action to treat the flu in
nearly 20 years.

About CAPSTONE-2

CAPSTONE-2 is a Phase III, multicenter, randomized, double-blind study
that evaluated a single dose of baloxavir marboxil compared with placebo
and oseltamivir in people 12 years or older who are at a high risk of
complications from the flu. 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. The study was conducted globally by Shionogi & Co., Ltd.

Participants enrolled in the study were randomly assigned to receive a
single dose of 40 mg or 80 mg of baloxavir marboxil (according to body
weight), placebo or 75 mg of oseltamivir twice a day for five days. The
primary objective of the study evaluated the efficacy of a single dose
of baloxavir marboxil compared with placebo by measuring the time to
improvement of influenza symptoms. Important secondary endpoints were
time to resolution of fever, time to cessation of viral shedding and the
proportion of participants positive for influenza virus titer, or virus
levels in the body, by time point, and incidences of influenza-related
complications.

About baloxavir marboxil

Baloxavir marboxil is a first-in-class, single-dose investigational oral
medicine with a novel proposed mechanism of action designed to target
the influenza ("flu") A and B viruses, including oseltamivir-resistant
strains and avian strains (e.g. H7N9, H5N1). Unlike other currently
available antiviral treatments, baloxavir marboxil is the first in a new
class of antivirals designed to inhibit the cap-dependent endonuclease
protein within the flu virus, which is essential for viral replication.

Baloxavir marboxil will also be studied in a Phase III development
program including pediatric and severely ill hospitalized populations
with influenza.

Baloxavir marboxil was discovered by Shionogi & Co., Ltd. and is being
developed globally by 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 baloxavir marboxil excluding Japan and Taiwan,
which will be retained exclusively by Shionogi & Co., Ltd. Baloxavir
marboxil was approved in February 2018 by the Japanese Ministry of
Health, Labour and Welfare for the treatment of influenza types A and B
in adult and pediatric patients, and is being commercialized in Japan
and marketed under the brand name Xofluza®.

About Genentech in influenza

Influenza, or flu, is one of the most common, yet serious, infectious
diseases. Globally, annual epidemics result in 3 to 5 million cases of
severe disease, millions of hospitalizations and up to 650,000 deaths
worldwide. For people at higher risk of flu complications, like
pneumonia and bronchitis, the flu can lead to hospitalization or death,
or can make long-term health problems worse. Although vaccines are an
important first line of defense in preventing the flu, there is a need
for new medical options for prophylaxis and treatment. Current
treatments – including vaccines and antiviral medicines – have
limitations as flu viruses are constantly changing and new antiviral
medicines are necessary. Genentech is committed to addressing the unmet
need in this area through its agreement with Shionogi & Co., Ltd. to
develop and commercialize baloxavir marboxil.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious and life-threatening medical
conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.

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