Market Overview

European Commission Approves Symtuza® for the Treatment of HIV-1 In Adults and Adolescents in Europe

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  • Symtuza® is the only darunavir-based
    single-tablet regimen (STR) approved for the treatment of HIV-1 in the
    European Union

Janssen-Cilag International NV (Janssen) today announced that the
European Commission has approved the use of Symtuza®
(darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF])1,
a once-daily darunavir-based single-tablet regimen (STR), for the
treatment of human immunodeficiency virus type 1 (HIV-1) infection in
adults and adolescents aged 12 years and older with body weight of at
least 40 kg. Cobicistat, emtricitabine and tenofovir alafenamide are
from Gilead Sciences, Inc.

The only darunavir-based STR indicated for the treatment of this patient
group, Symtuza® combines the proven efficacy and durability
of darunavir with the improved renal laboratory and bone mineral density
profile of F/TAF as compared to F/TDF (emtricitabine/tenofovir
disoproxil fumarate). It is the only approved treatment to offer the
convenience of a STR alongside the high genetic barrier to resistance
provided by darunavir.

"There are almost one million people in the European Union currently
living with HIV. The availability of a single-treatment regimen with a
high barrier to resistance mutations eliminates the need for separate
tablets, reducing the burden of pills on daily life for patients, and
helping them to achieve improved treatment adherence and viral
suppression," said Jean-Michel Molina, Professor of Infectious Diseases
at the University of Paris Diderot.

"At Janssen, we are committed to developing effective and innovative
treatments which address the issues of adherence and resistance. Today's
approval by the European Commission demonstrates our efforts to treat
HIV more simply, helping all those living with HIV to achieve an
undetectable viral load while enjoying an improved quality of life,"
said Lawrence M. Blatt, Ph.D., Global Therapeutic Area Head, Janssen
Infectious Diseases Therapeutics.

Results from a bioequivalence study that compared Symtuza®
with the combined administration of the separate agents darunavir [D]
800 mg, cobicistat [C] 150 mg, and emtricitabine/tenofovir alafenamide
[FTC/TAF] 200 mg/10 mg fixed-dose combination were presented at the
International AIDS Society (IAS) conference in Paris, France in July.2
These results confirmed that the once-daily STR is bioequivalent to the
combined administration of the separate agents, as well as demonstrating
that the STR is well tolerated.

In addition, results from the pivotal Phase 3 EMERALD study presented at
IAS showed that the once-daily STR containing darunavir 800 mg,
cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg
[D/C/F/TAF] had a low cumulative virologic rebound rate and a high
virologic suppression rate at 24 weeks in HIV-1 positive, virologically
suppressed adults who switched from a standard boosted protease
inhibitor (PI) plus tenofovir/emtricitabine regimen. A Phase 3 clinical
trial programme investigating the efficacy and safety of the
darunavir-based combination is ongoing. In October, EMERALD 48-week data
will be presented at ID Week 2017 in San Diego, California, USA, and
48-week data from the Phase 3 AMBER trial in antiretroviral therapy
(ART) naïve patients will be presented at the European AIDS Clinical
Society (EACS) Conference in Milan, Italy.3,4

On 20 July, the European Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) issued a positive opinion
for Symtuza®.5 This subsequent European Commission
approval allows Janssen to market Symtuza® in all countries
in the European Union and European Economic Area.1

###

Notes to editors

On 23 December 2014, Janssen and Gilead Sciences International Ltd
amended a licensing agreement for the development and commercialisation
of a once-daily STR combination of darunavir and Gilead's TAF,
emtricitabine and cobicistat. Under the terms of the
agreement, Janssen and its affiliates are responsible for the
manufacturing, registration, distribution and commercialisation of this
STR worldwide.

About Symtuza®

In the European Union, Symtuza® is indicated for the
treatment of human immunodeficiency virus type 1 (HIV-1) infection in
adults and adolescents (aged 12 years and older with body weight at
least 40 kg). Genotypic testing should guide the use of Symtuza®.

Symtuza® is a fixed-dose combination of four active
substances (darunavir, cobicistat, emtricitabine and tenofovir
alafenamide), available as 800 mg/150 mg/200 mg/10 mg film-coated
tablets. Darunavir inhibits the HIV protease and prevents the formation
of mature infectious virus particles. Emtricitabine and tenofovir
alafenamide are substrates and competitive inhibitors of HIV reverse
transcriptase. After phosphorylation, they are incorporated into the
viral DNA chain, resulting in chain termination. Cobicistat enhances the
systemic exposure of darunavir and has no direct antiviral effect.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are
working to create a world without disease. Transforming lives by finding
new and better ways to prevent, intercept, treat and cure disease
inspires us. We bring together the best minds and pursue the most
promising science. We are Janssen. We collaborate with the world for the
health of everyone in it. Learn more at www.janssen.com/emea
and follow us at @JanssenEMEA.

Cautions Concerning Forward-Looking
Statements

This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
development of potential preventive and treatment regimens for HIV. 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 the Janssen Pharmaceutical Companies and
Johnson & Johnson. Risks and uncertainties include, but are not limited
to: challenges and uncertainties inherent in product development,
including uncertainty of clinical success and obtaining regulatory
approvals; uncertainty of commercial success for new indications and
therapeutic combinations; competition, including technological advances,
new products and patents attained by competitors; challenges to patents;
product efficacy or safety concerns resulting in product recalls or
regulatory action; changes in behaviour and spending patterns of
purchasers of health care products and services; 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 year ended January 1, 2017,
including under "Item 1A Risk Factors," its most recently filed
Quarterly Report on Form 10-Q, including in the section captioned
"Cautionary Note Regarding Forward-Looking Statements," and the
company's subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at
www.sec.gov,
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 European Medicines Agency http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004391/smops/Positive/human_smop_001176.jsp&mid=WC0b01ac058001d127

2 9th IAS Conference on HIV Science 2017 http://www.ias2017.org/Portals/1/Files/IAS2017_LO.compressed.pdf?ver=2017-07-27-211231-197

3 ID Week 2017 https://idsa.confex.com/idsa/2017/webprogram/start.html

4 16th European AIDS Conference http://www.eacs-conference2017.com/index.php?article_id=147

5 European Medicines Agency, Symtuza Summary of opinion http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004391/WC500231710.pdf

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