Market Overview

Janssen Announces Phase 3 Pivotal Study Results for Darunavir-Based Complete Treatment Regimen


- Interim results from the pivotal EMERALD trial presented during an
oral session at the International AIDS Society Conference show a low
cumulative virologic rebound rate and a high virologic suppression rate
at 24 weeks -

Janssen-Cilag International NV (Janssen) today announced that an
investigational single-tablet regimen (STR) containing darunavir is
effective and well tolerated. Results from the pivotal Phase 3 EMERALD
study showed that a 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 human immunodeficiency virus
type 1 (HIV-1) positive, virologically suppressed adults who switched
from a standard boosted protease inhibitor (PI) regimen. These results
were presented in an oral session at the 9th International
AIDS Society Conference on HIV Science (IAS 2017) in Paris, France.

The darunavir-based STR received a Positive Opinion from the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) earlier this month recommending marketing authorization
under the brand name of Symtuza™ in the European Union. If approved, it
would be the first darunavir-based complete regimen for the treatment of
HIV-1 in adults and adolescents (aged 12 years and older with a body
weight of at least 40kg, with genotypic testing guiding use), combining
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 (tenofovir disoproxil fumarate).

"The complexity and high pill burden of some HIV treatment regimens can
result in non-adherence, which is one of the major contributors to the
development of HIV drug resistance," said Professor Jean-Michel Molina,
Professor of Infectious Diseases, Department of Infectious Diseases,
St-Louis Hospital, University of Paris Diderot, Paris, France. "These
promising results show that the darunavir-based STR was highly effective
and well tolerated, providing a complete treatment regimen with a high
genetic barrier to resistance with just one single daily tablet. If we
can help to reduce the treatment burden for patients living with HIV-1,
this can help to improve adherence which we know is essential for
achieving viral suppression and reducing the emergence of resistance

EMERALD is a 48-week, non-inferiority study evaluating the efficacy and
safety of switching to D/C/F/TAF (n=763) versus continuing on a boosted
PI plus F/TDF regimen (n=378). Cumulative virologic rebound, defined as
confirmed viral load (VL)≥50c/mL or premature discontinuations, with
last VL≥50 c/mL, was 1.8% (n=14 D/C/F/TAF) vs 2.1% (n=8 control) of
which 10/14 and 5/8, respectively, resuppressed (<50c/mL) by Week 24,
and there were no confirmed rebounds ≥200c/mL. At Week 24, virologic
suppression, defined as VL<50c/mL, was 96.3% (D/C/F/TAF) and 95.5%
(control), and virologic failure occurred in 0.5% and 0.8% of patients,
respectively, with no discontinuations for virologic failure and no
detected resistance to any study drug.

Safety was similar between the study arms through 24 weeks with low
incidences of Grade 3-4 adverse events (AEs) – 4.5% (D/C/F/TAF) and 4.5%
(control); serious AEs – 2.6% (D/C/F/TAF) vs 3.2% (control); and
treatment discontinuations – overall, 2.9% (D/C/F/TAF) vs 2.9%
(control), and due to AEs, 1.4% (D/C/F/TAF) vs 1.1% (control). The most
common AEs (≥5% both arms) were nasopharyngitis; upper respiratory tract
infection (URI) and vitamin D deficiency. There were no deaths reported
during the interim analysis.

"Over the past decade, Janssen has developed a broad range of therapies
for people living with HIV that have helped to transform the management
of patients living with the disease. Darunavir is one of the most widely
used HIV medicines globally and it offers a high genetic barrier to
resistance," said Lawrence M. Blatt, Ph.D., Global Therapeutic Area
Head, Infectious Disease Therapeutics, Janssen. "We remain dedicated to
fulfilling our mission of delivering transformational innovations to
meet the diverse needs of the HIV community and are excited to be
bringing forward an evolved therapy with darunavir as its backbone. If
approved, it has the potential to not only offer the benefits of
darunavir but could also reduce the treatment burden faced by those
taking life-long HIV therapy, which may help to address the issues of
both adherence and resistance."

Additional Darunavir Data at IAS 2017

Two new analyses presented at the conference provide further support for
a darunavir-based STR in the treatment of HIV. The first confirmed that
the STR is bioequivalent to the combined administration of the separate
agents. The bioequivalence study also found the STR was well tolerated.
The other poster presentation evaluated the prevalence of darunavir
resistance-associated mutations (RAMs) and primary PI resistance from
2010-2015 in clinical samples from the Monogram database and found the
prevalence of darunavir RAMs remained low and generally stable.

Treatment regimens that combine DRV/C (REZOLSTA®,
Janssen-Cilag International NV, U.S name PREZCOBIX®) and
F/TAF (DESCOVY®, Gilead Sciences International Ltd) are
currently approved1,2 for the treatment of HIV-1.

Please visit
for further details on the breadth of science being presented by Johnson
& Johnson companies and its partners at IAS 2017.


Notes to editors

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

About the EMERALD clinical trial

The Phase 3 EMERALD study is a randomized (2:1), open-label,
international, multicenter, parallel-group, non-inferiority, 48-week
study evaluating the efficacy and safety of switching to D/C/F/TAF
versus continuing with a boosted PI plus F/TDF (control) in patients who
are virologically suppressed (VL<50c/mL) for ≥2 months and had no more
than once a viral load VL≥50c/mL over the last 12 months. The
FDA-stipulated primary endpoint of the trial is the proportion of
patients with cumulative virologic rebound (confirmed VL≥50c/mL or
premature discontinuations with last VL≥50c/mL) through Week 48
(non-inferiority margin=4%). 1141 patients were randomized and treated
as follows: D/C/F/TAF (n=763); control (n=378).

For more information on the clinical trials please visit:


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About REZOLSTA® (darunavir/cobicistat)

REZOLSTA is an antiviral medicine used, in combination with other
medicines, to treat adults with human immunodeficiency virus type 1
(HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
REZOLSTA contains the active substances darunavir and cobicistat. The
medicine is for use only in patients who have not received HIV treatment
before or previously treated patients whose disease is not expected to
be resistant to darunavir and who are healthy enough and have HIV virus
levels below a certain threshold.

Cautions Concerning Forward-Looking

This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
development of treatment and prevention options 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 Janssen Sciences Ireland UC, any of the
other Janssen Pharmaceutical Companies and/or 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; 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 most recent Annual Report on Form 10-K, 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,
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


1 . European Medicines Agency: Last
accessed June 2017.

2 . European Medicines Agency: Last
accessed June 2017.

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