Business Wire

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

Jaa

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 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 approved1,2 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.

###

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.

Contact information

Janssen
MEDIA CONTACTS:
Ronan Collins
+47 488 425 00
rcollin5@its.jnj.com
or
Katie Buckley
+44 7971 956 179
kbuckle8@its.jnj.com
or
Gavin Hart
+1 917 686 9221
Ghart9@its.jnj.com
or
INVESTOR RELATIONS:
Lesley Fishman
Phone: +1 732-524-3922
or
Joseph J. Wolk
Phone: +1 732-524-1142

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Mobile Ticket Option Launches for Tampa Bay CityPASS17.10.2017 12:00Tiedote

City Pass, Inc., the company that specializes in packaging discounted admission to the most iconic attractions in 12 North American destinations, recently launched a mobile ticket option for its Tampa Bay CityPASS® program. Since 1997, CityPASS products have been designed to make travel easier and less expensive. And while the Tampa Bay CityPASS program will continue to excel at the latter—saving visitors 51 percent off combined admission to the included attractions—the new mobile ticket option dramatically enhances the convenience factor. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171017005538/en/ Busch Gardens Tampa Bay (Photo: SeaWorld Parks & Entertainment, Inc.) “We’re always looking for ways to improve the customer experience and make travel more convenient,” said CityPASS President a

Opus Trust Marketing Invests in Pitney Bowes’ Technology to Accelerate Growth17.10.2017 11:00Tiedote

Pitney Bowes Inc. (NYSE:PBI), a global technology company providing innovative products and solutions to power commerce, today announced that it has won a contract with Leicester-based Opus Trust Marketing. The contract will help Opus Trust accelerate growth and deliver its ambitious strategic development plans. Opus Trust specialises in multichannel communications, critical document printing and mailing for a diversity of high profile clients, including 20% of the FTSE 100. It is investing in Pitney Bowes’ Pulse™ inserting system as well as two of Pitney Bowes’ high-performance multi format inserters, Epic™. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171017005541/en/ The Pulse™ inserting system (Photo: Business Wire) Opus Trust is also investing its time in Pitney Bowes’ digital cus

NEC Europe Appoints Hironobu Kurosaki as President and CEO17.10.2017 11:00Tiedote

NEC Europe Ltd. today announced the appointment of Hironobu Kurosaki as President and CEO. In this role, Mr. Kurosaki will lead the growth of NEC Europe’s business for a broad range of customers spanning across its key business segments of Public Safety, Public IT services and Telecom Carrier Solutions in the EMEA region (Europe, the Middle East and Africa). Since joining NEC in 1983, Mr. Kurosaki has gained extensive international experience in the development of sales, marketing and strategy throughout the Americas and EMEA. In recent years, he has played a leading role in the development of NEC’s global business, where his experience as President of NEC Telecommunication and Information Technology Ltd. (Turkey), and contributions as General Manager of NEC’s Americas and EMEA Division have helped to deliver high-powered solutions and drive new growth in strategic ma

MagicStay, The Start-up of Short-Term Rental for Business, Affirms Its Ambitions at the Web Summit 201717.10.2017 11:00Tiedote

The French start-up MagicStay.com launched 3 years ago, now offers more than 130,000 apartments in 110 countries on its specialized platform for business travelers. As the only 100% B2B platform, MagicStay has developed many services adapted to the requirements of businesses, especially in terms of security and integration into their tools, which will be presented at the Web Summit in Lisbon from 6 to 9 November. For three years now, the start-up has been developing an exclusive technology that makes it possible to provide a global supply of short-term rentals in immediate reservations. These professionally managed accommodations meet corporate requirements: security, legislation compliance, and integration into booking tools used by corporate companies. "The Business Travel Market is very complex in terms of technology and actors, and is highly

Sigma Systems Appoints Vladimir Mitrasinovic as Senior Vice-President of Sales and Managing Director for EMEA and APAC17.10.2017 11:00Tiedote

Sigma Systems, the leader in catalog-driven software, has appointed Vladimir Mitrasinovic as Senior Vice-President of Sales and Managing Director for EMEA and APAC. Mr. Mitrasinovic was previously Head of the Cloud and Software as a Service business unit for Cerillion Technologies, and served as Executive Vice-President of Global Channels and Alliances at Acision (XURA). As Senior Vice President of Sales and Managing Director of EMEA and APAC, Vladimir will oversee all sales and business development efforts within the regions. “We are delighted to welcome Vladimir to the Sigma team,” said Simon Muderack, Sigma’s Executive Vice President and Chief Commercial Officer. “Vladimir’s background in high-growth corporate development in the technology sector and experience in sales and business expansion will be an excellent asset to Sigma as we continue to expand across EMEA and

REFLEX CES Partners with NOLAM EMBEDDED SYTEMS to Provide Integrated CANbus IP Core Solutions on FPGA COTS Boards17.10.2017 10:00Tiedote

NOLAM EMBEDDED SYSTEMS, manufacturer of semiconductor IP and board level products and systems for the Aerospace, Defense, telecom and industrial markets, today announced their partnership with REFLEX CES, a leading provider of complex, high-density FPGA-based boards. This partnership benefits customers by providing them a fully integrated solution based on REFLEX CES FPGA boards and NOLAM EMBEDDED SYSTEMS CANbus IP core and CANbus FMC module. «We are thrilled to collaborate with REFLEX CES to offer a fully integrated CANbus solution», stated Benjamin Nakache, Vice-President of Sales at Nolam Embedded Systems «By integrating our CANbus IP solution with our CANbus FMC to the REFLEX CES hardware, we bring a very easy-to use solution to CANbus users in the automotive industry.» One of the first outcomes of this collaborative venture is the release of an SDK, composed of REF

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme