Business Wire

ViiV Healthcare Gains CHMP Positive Opinion for Juluca (dolutegravir/rilpivirine) in Europe

Del

ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor. The 2-drug regimen comprises dolutegravir 50mg (ViiV Healthcare) and rilpivirine 25mg (Janssen Sciences Ireland UC).

Deborah Waterhouse, Chief Executive Officer at ViiV Healthcare commented: “Today is an important milestone for people living with HIV in Europe. It takes us a step closer to offering the first, single-pill, 2-drug regimen with the opportunity to reduce the number of drugs needed to treat HIV in those who are virologically suppressed; Juluca is expected to be the smallest single-pill regimen in the market. ViiV Healthcare is committed to delivering advances in HIV care, including providing innovative treatment options that meet the evolving needs of people living with HIV and we are willing to challenge the traditional HIV treatment paradigms to deliver these advances.”

The CHMP positive opinion follows the United States Food and Drug Administration approval of Juluca in November 2017 for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of dolutegravir/rilpivirine;1 and is supported by data from two pivotal phase III clinical trials, SWORD-1 and SWORD-2, and a pivotal bioequivalence study.2,3

Positive data from the SWORD studies, recently published in The Lancet (5th January 2018), showed that the dolutegravir and rilpivirine regimen is non-inferior to three and four drug regimens in maintaining virologic suppression (HIV-1 RNA less than 50 copies per mL) through 48 weeks in adults who are infected with HIV-1 and have no history of resistance or treatment failure, in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies (dolutegravir+rilpivirine 486/513 [95%] current antiretroviral regimen 485/511 [95%], [adjusted difference -0.2% (95% confidence interval: -3.0%, 2.5%), pooled analysis]). Virologic suppression rates were similar between treatment arms.2

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented: “We believe no one should have to take more medicines than they need, and dolutegravir/rilpivirine represents our first 2-drug regimen that could reduce the number of antiretrovirals people living with HIV in Europe take daily, whilst maintaining the efficacy of traditional three-drug regimens. Our research efforts are exploring a number of two-drug regimen treatment options that look beyond viral load and may address unresolved issues, such as long-term toxicity and reducing the number of drugs used in dosing.”

A CHMP opinion is one of the last regulatory steps before marketing authorisation is granted by the European Commission (EC). The final EC decision on European approval for dolutegravir/rilpivirine is anticipated towards the end of the second quarter of 2018.

– Ends

Notes to editors
In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced a collaboration to investigate the potential of combining dolutegravir and rilpivirine in a single pill in order to expand the treatment options available to people living with HIV.

About HIV
HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.

HIV has largely become a chronic treatable disease with improved access to antiretroviral treatment. This has led to a 22% drop in global HIV mortality between 2009 and 2013,4 but more can be done for the estimated 36.7 million people living with HIV4 of which 160,000 were newly diagnosed in the Europe region alone in 2016.5

About dolutegravir/rilpivirine
Dolutegravir/rilpivirine was approved by the US Food and Drug Administration (FDA) on 21st November 2017, as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of dolutegravir/rilpivirine.1

Dolutegravir/rilpivirine is a 2-drug regimen, once-daily, single pill that combines the integrase strand transfer inhibitor (INSTI) dolutegravir (50mg), with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (25mg) taken once-daily as a complete HIV regimen for people living with HIV who are virologically suppressed.

Two essential steps in the HIV life cycle include reverse transcription – when the virus turns its RNA (ribonucleic acid) copy into DNA (deoxyribonucleic acid) – and integration – the moment when viral DNA becomes part of the host cell’s DNA. These processes require two enzymes called nucleoside reverse transcriptase and integrase. NNRTIs and INSTIs interfere with the action of these two enzymes to prevent the virus from replicating. This decrease in replication can lead to less virus being available to cause subsequent infection of uninfected cells.

ViiV Healthcare has also submitted regulatory marketing applications in Canada, Australia and Switzerland.

About the SWORD phase III programme for dolutegravir (Tivicay) and rilpivirine (Edurant) 2
The SWORD phase III programme evaluates the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three or four-drug regimen. SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomised, open-label, non-inferiority studies to assess the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir plus rilpivirine compared with current antiretroviral therapy (full 148-week data will be shared in 2019). In the SWORD clinical trials, dolutegravir and rilpivirine are provided as individual tablets.

The primary endpoint is the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at Week 48. Key secondary endpoints include evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. The studies also include exploratory measures to assess change in health-related quality of life, willingness to switch and adherence to treatment regimens.

For more information on the trials please visit: www.clinicaltrials.gov

Juluca and Tivicay are trademarks owned by the ViiV Healthcare group of companies.

EDURANT is a registered trademark of Janssen Sciences Ireland UC.

Important Safety Information for dolutegravir/rilpivirine in Europe: Please refer to the full European Summary of Product Characteristics for full prescribing information for dolutegravir and rilpivirine.

About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

GSK - a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com.

References
___________________________
1 Juluca (dolutegravir and rilpivirine) Prescribing Information. Initial U.S Approval: 2017
2 Llibre JM, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. The Lancet. Published online January 5, 2018 http://dx.doi.org/10.1016/S0140-6736(17)33095-7.
3 Metha R, et al. Bioequivalence of a fixed dose combination tablet of dolutegravir and rilpivirine in healthy subjects. Presented at the 18th Workshop on Clinical Pharmacology of Antiviral Therapy, 2017. Chicago, United States.
4 World Health Organization. Global Update on the health sector response to HIV, 2014. July 2014. Available at: http://apps.who.int/iris/bitstream/10665/128494/1/9789241507585_eng.pdf?ua=1. Last accessed March 2018.
5 World Health Organization. Infographic. Available at: http://www.euro.who.int/en/health-topics/communicable-diseases/hivaids/data-and-statistics/infographic-newly-diagnosed-hiv-infections-in-the-who-european-region,-2016. Last accessed March 2018.

Contact information

ViiV Healthcare
Media enquiries:
Patricia O’Connor
+44-208-047-5982
or
Marc Meachem
+1-919-483-8756
or
GSK Global
Media enquiries:
Simon Steel
+44 (0) 20-8047-5502
or
David Daley
+44 (0) 20-8047-5502
or
Analyst/Investor enquiries:
Sarah Elton-Farr
+44 (0) 20-8047-5194
or
Tom Curry
+ 1-215-751-5419
or
Gary Davies
+44 (0) 20-8047-5503
or
James Dodwell
+44 (0) 20-8047-2406
or
Jeff McLaughlin
+1-215-751-7002

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Western Union Teams Up with Thunes to Expand Payout Capabilities to Mobile Wallets19.3.2019 01:00:00 CETPressemelding

Western Union (NYSE: WU), a leader in cross-border, cross-currency money movement, has teamed up with Thunes, a cross-border payments network for emerging markets, to enable Western Union customers to send funds directly into mobile wallets around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005639/en/ Senders can now utilise Western Union’s growing digital network or an agent location to send funds directly into a recipient’s mobile wallet. “We are continuously expanding and enhancing our account payout portfolio, providing customers with multiple payout options including bank accounts, cards or mobile wallets,” said Sobia Rahman, Global Head of Account Payout Network for Western Union. “Our goal is to make digital money transfer services more accessible, with a specific focus on enabling mobile transactions.” The collaboration will enable greater financial access for consumers - especially those who lack

Velodyne Demonstrates Lidar Solution for Rich Perception Data Collection on NVIDIA DRIVE Platform19.3.2019 01:00:00 CETPressemelding

Velodyne Lidar, Inc. today announced its surround-view lidar solutions for collecting rich perception data in testing and validation are available on the NVIDIA DRIVE™ autonomous driving platform--allowing full, 360-degree perception in real time, facilitating highly accurate localization and path-planning capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005791/en/ Proven through learning from millions of road miles, Velodyne sensors help determine the safest way to navigate and direct a self-driving vehicle. (Photo: Business Wire) Velodyne sensors’ characteristics are also available on NVIDIA DRIVE Constellation™, an open, scalable simulation platform that enables large-scale, bit-accurate hardware-in-the-loop testing of AVs. The solution’s DRIVE Sim™ software simulates lidar and other sensors, recreating a self-driving car’s inputs with high fidelity in the virtual world. “Velodyne and NVIDIA are at the f

Kohler Celebrates the Details of Design at Milan Design Week 201919.3.2019 00:22:00 CETPressemelding

Kohler, a global lifestyle brand, returns to Milan Design Week to host an enticing sensory experience inside the historic Palazzo Del Senato (via Senato, 10, 20121 Milan, Italy). The large-scale immersive exhibit showcases Kohler’s bold approach to design and the brand’s most stunning products through an artful combination of water, technology, texture, and color. The installation will be open April 9 through April 13 from 10am – 7pm daily. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005858/en/ The large-scale immersive exhibit showcases Kohler’s bold approach to design and the brand’s most stunning products through an artful combination of water, technology, texture, and color. The installations feature global debuts of products from KOHLER, KALLISTA, ANN SACKS and ROBERN. (Photo: Business Wire) “Milan Design Week is the ultimate celebration of creativity and innovation among the global design community,” said Jim

ams and Wise Road Capital Advance Further Development for Environmental, Flow and Pressure Sensors Through Creation of a Joint Venture19.3.2019 00:09:00 CETPressemelding

ams (SIX: AMS), a leading worldwide supplier of high performance sensor solutions, and Wise Road Capital, a global Private Equity firm focusing on the semiconductor industry and other emerging high-tech industries, announce today that they have signed an agreement to create a joint venture to advance the development and sales of environmental, flow and pressure sensor solutions for the global market. Under the agreement, employees, IP, sensor products and solutions and related customers will transfer from ams to the joint venture, while Wise Road Capital will provide its expert joint venture guidance, deep market knowledge and strength in channel and customer relationships, especially in China. ams will transfer its current environmental sensor solution portfolio covering air quality, relative humidity and temperature sensing, which are used in automotive, smart building and air quality monitoring infrastructure applications. In addition, the ams ultrasound-based flow sensor solutions,

The We Company FY 2018 Financial Results Conference Call18.3.2019 23:44:00 CETPressemelding

WeWork Companies Inc. (the “Company”), as issuer of its 7.875% Senior Notes due 2025 (the “Senior Notes”), will hold a conference call on Monday, March 25, 2019, at 5:00 P.M. Eastern Time for the benefit of certain qualified participants in order to discuss the Company’s financial results for the fiscal year 2018. Current holders and beneficial owners of the Senior Notes, bona fide prospective purchasers of the Senior Notes who are qualified institutional buyers (as defined in Rule 144A under the Securities Act of 1933) or non-U.S. persons (as defined in Regulation S under the Securities Act of 1933), securities analysts, and market-making financial institutions may gain access to the call information for the conference call by registering on the Company’s secure website at investors.wework.com. Additional information about the call (including dial-in number) will be provided on the secure website. Parties requesting access to the Company’s secure website will be required to provide ce

FANCL Regains Control of Their IT Roadmap by Switching to Rimini Street Support for its SAP Application18.3.2019 23:00:00 CETPressemelding

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that FANCL, a leading additive-free cosmetics and health food products company in Japan, has switched to Rimini Street support for its SAP ECC 6.0 system. Rimini Street has enabled FANCL to take full control of their ERP roadmap and chart its direction based on the company’s business needs -- like advancing their digital transformation initiatives -- versus continuing to follow a vendor-dictated roadmap. Additionally, FANCL now receives premium-level, ultra responsive support for its current, stable SAP system for a minimum of 15 years from the time the company transitioned to Rimini Street. The company also immediately realized savings of 50 percent in annual support fees. FANCL is able to reinvest this significant cost saving into updating and modernizing the company’