New Data Published in the New England Journal of Medicine Shows Potential of Compound to Fight RSV Infection in Adults and Children

San Francisco (ots/PRNewswire) -

- ALS-008176 now being evaluated in RSV-infected infants -

Alios BioPharma, Inc., part of the Janssen Pharmaceutical
Companies announced that the New England Journal of Medicine (NEJM)
will publish findings from a respiratory syncytial virus (RSV)
challenge study for ALS-008176, a cytidine nucleoside analog with
activity against RSV.[1] Among infants and young children, RSV is the
leading cause of severe respiratory illness and remains the most
frequent cause of hospitalization in industrialized countries.[2]
This Phase 2a study has now established human proof-of-concept for
the antiviral activity of ALS-008176 in healthy adults and highlights
its potential as a therapy for managing clinical disease in naturally
infected patients.[1]

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"The data suggest that ALS-008176 has the potential to be a safe
and effective treatment for RSV infection. The primary endpoint of
the study was met and ALS-008176 significantly reduced viral load and
symptoms of disease severity compared to placebo," said John
DeVincenzo, M.D., the lead study author and Professor of Pediatrics,
and Professor of Microbiology, Immunology and Biochemistry at the
University of Tennessee Health Science Center, and Medical Director
of Molecular and Viral Diagnostics at Le Bonheur Children's Hospital.
"ALS-008176 can inhibit the replication of RSV even if the cells of
the respiratory tract have already been infected with the virus. As a
result, this treatment has an antiviral effect and is likely to be
effective even if started at a later stage of RSV infection."

In this randomized, double-blind study, 62 healthy volunteers were
inoculated with RSV and subsequently randomized to receive ALS-008176
or placebo. Compared to placebo, treatment with ALS-00876 resulted in
a significant reduction of viral load (73-88% reduction in viral load
area under the curve) and faster viral clearance (1.3-2.3 days vs 7.2
days) versus placebo. At the time that the peak viral load occurred
in the placebo group, the mean viral load in each of the three
ALS-007186 treatment groups was more than one thousand times lower.
In addition, statistically significant reductions in symptom scores
and a reduction of the amount of congesting respiratory secretions
were also observed.[1]

In the study, no serious adverse events (SAEs), premature
discontinuations of study drug, or clinically significant treatment
related adverse events (AEs) were observed. The most commonly
reported AEs were epistaxis (bleeding from the nose), upper
respiratory infection and cough. AEs were generally balanced in terms
of frequency and intensity across recipients of ALS-008176 and
placebo. ALS-008176 also demonstrated a high barrier to resistance.
No participants receiving ALS-008176 experienced viral rebound or had
evidence of viral resistance during the course of the study.[1]

RSV is a seasonal virus that affects the lungs and airways for
which there is currently no vaccine and no guideline-recommended
antiviral treatment options available. RSV can be partially prevented
by a monoclonal antibody, but its use is limited to a small fraction
of premature infants or infants with uncommon heart or lung
problems.[2],[3] Each year, there are approximately 64 million cases
of RSV infection among adults and children and nearly 100% of infants
will have at least one RSV infection by their second year of life.[4]
In a single year (2005), around 33.8 million infants and young
children had RSV infections in the lower respiratory tract and at
least 3.4 million were hospitalized. This was associated with between
66,000 and 199,000 deaths.[5]

"Janssen is currently working on the discovery and development of
multiple treatment and vaccine candidates against RSV infection,"
said Lawrence M. Blatt, PhD, Global Therapeutic Area Head Infectious
Diseases and Vaccines, Janssen Research & Development, LLC. "The data
published in the New England Journal of Medicine highlight the
potential this new compound has to effectively treat patients
suffering from severe RSV infection. It underscores our commitment to
develop highly innovative healthcare solutions in areas of great
unmet need."

ALS-008176 is an orally bioavailable prodrug of the RSV
replication inhibitor ALS-008112, a cytidine nucleoside analog. It is
designed to inhibit the replication of RSV by acting on the viral
polymerase and is currently being evaluated in hospitalized
RSV-infected infants.

About the Janssen Pharmaceutical Companies

At Janssen, we are dedicated to addressing and solving some of the
most important unmet medical needs of our time in oncology,
immunology, neuroscience, infectious diseases and vaccines, and
cardiovascular and metabolic diseases. Driven by our commitment to
patients, we develop innovative products, services and healthcare
solutions to help people throughout the world. Alios BioPharma Inc.,
and Janssen Research & Development, LCC are part of the Janssen
Pharmaceutical Companies. Please visit http://www.janssen.com for
more information.

About Janssen's Development Programs in Respiratory Diseases

Janssen is dedicated to the ongoing research and development of
innovative solutions which will help to prevent and treat severe
respiratory infections including influenza and human respiratory
syncytial virus (RSV), with the goal of reducing worldwide burden.
Janssen is currently working on the discovery and development of
multiple treatment and vaccine candidates against influenza and RSV.

Within RSV, our development program includes the cytidine
nucleoside analog inhibitor ALS-008176. This compound is currently
being evaluated in clinical studies in the hospital setting. We also
have an investigational fusion inhibitor which is currently
undergoing a Phase 2a human challenge study and an RSV vaccine
candidate Ad35.RSV.FA2 which has entered a Phase 1 study in the U.S
to evaluate the safety, tolerability and immunogenicity in healthy
adults.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development. The reader is cautioned not to rely on
these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions
prove inaccurate or known or unknown risks or uncertainties
materialize, actual results could vary materially from the
expectations and projections of Alios BioPharma, Inc. and/or Johnson
& Johnson. Risks and uncertainties include, but are not limited to:
challenges and uncertainties inherent in new product development,
including uncertainty of clinical success and obtaining regulatory
approvals; competition, including technological advances, new
products and patents attained by competitors; challenges to patents;
changes to applicable laws and regulations, including global health
care reforms; and trends toward health care cost containment. A
further list and description of these risks, uncertainties and other
factors can be found in Johnson & Johnson's Annual Report on Form
10-K for the fiscal year ended December 28, 2014, including in
Exhibit 99 thereto, and the company's subsequent filings with the
Securities and Exchange Commission. Copies of these filings are
available online at http://www.sec.gov, http://www.jnj.com or on
request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertakes to update any
forward-looking statement as a result of new information or future
events or developments.

1. DeVincenzo JP, et al. Activity of Oral ALS-008176 in a
Respiratory Syncytial Virus Challenge Study. New England Journal of
Medicine. 19 November 2015.

2. American Academy of Pediatrics Committee on Infectious
Diseases, American Academy of Pediatrics Bronchiolitis Guidelines
Committee. Updated guidance for palivizumab prophylaxis among infants
and young children at increased risk of hospitalization for
respiratory syncytial virus infection. Pediatrics 2014;134:415-20.

3. Centers for Disease Control and Prevention. Respiratory
Syncytial Virus Infection (RSV): For Healthcare Professionals
[Online]. Available at:http://www.cdc.gov/rsv/clinical/ Last accessed
October 2015.

4. World Health Organization. Initiative for Vaccine Research:
Acute Respiratory Infections [Online]. Available at:
http://apps.who.int/vaccine_research/diseases/ari/en/index2.html Last
accessed October 2015.

5. Nair H, et al. Global burden of acute lower respiratory
infections due to respiratory syncytial virus in young children: a
systematic review and meta-analysis. Lancet. 2010;375:1545-55.

ots Originaltext: Alios BioPharma, Inc., part of the Janssen Pharmaceutical Companies
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Daniel De Schryver (Global) Mobile: +49-173-76-89-149 Email:
ddschryv@its.jnj.com