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

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 9^th 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 mutations.”

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 approved^1,2 for the treatment of HIV-1.

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

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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: www.clinicaltrials.gov

About

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 and follow us at @JanssenGlobal.

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 Statements

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 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.

References:

¹ . European Medicines Agency:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002819/human_med_001817.jsp&mid=WC0b01ac058001d124 Last accessed June 2017.

² . European Medicines Agency:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004094/human_med_001978.jsp&mid=WC0b01ac058001d124 Last accessed June 2017.

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