GSK GlaxoSmithKline plc

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

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.

EN
23/03/2018

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on GlaxoSmithKline plc

GSK: 1 director

A director at GSK sold 3,551 shares at 1,687p and the significance rating of the trade was 55/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly showing Close p...

Dominic Rose ... (+2)
  • Dominic Rose
  • Naresh Chouhan

GSK - It’s Not Sexy But It Is a BUY (TP £19 [£14.50], 14 pgs)

Following new analysis on current growth drivers & upcoming pipeline readouts, we upgrade our 2028 revenues by £2.5bn & believe GSK can deliver 11% CAGR EPS growth 2024-27 leaving us 7% above consensus 2027 EPS. Whilst we believe 2029-31 is an unfillable hole & justifies a low multiple on Pharma, this is more than in the price and near-term momentum will likely drive the shares higher. The Zantac overhang clearing, some pipeline catalysts & the potential for fresh management coupled with near-te...

Dominic Rose ... (+2)
  • Dominic Rose
  • Naresh Chouhan

EU Pharma - 2024 Year Ahead (28 pgs)

For EU Pharma, 2024 is likely to be characterised by EPS revisions, a handful of new launches & sluggish EPS growth for a number of names. The relative lack of pipeline catalysts makes forecasting sales and EPS much more important than for 2023. We identify 4 key issues to watch for: 1) Medicaid AMP cap removal, 2) Higher tax costs, 3) Higher debt costs & 4) a handful of very specific company issues that could make a material difference to performance (Novo: Wegovy supply, GSK: litigation, SAN: ...

Dominic Rose ... (+2)
  • Dominic Rose
  • Naresh Chouhan

GSK - 30% EBIT Decline 2027-29

Our analysis of the impact of IRA on the 6 EU Pharma names shows GSK is most exposed this decade & we cut to HOLD. Shingrix & Trelegy US price cuts may account for a 7% EBIT hit in 2028. This happens at the same time as the ViiV patent losses leading to ~1/3 of group EBIT being lost 2027-29. We argue that GSK should aggressively cut costs today to boost M&A firepower to try to plug the hole. In the absence of this, we see limited ability to minimise the end of decade earnings losses. We also see...

Dominic Rose ... (+2)
  • Dominic Rose
  • Naresh Chouhan

EU Pharma - IRA Impact Analysed (Thematic Research, 16pgs)

The IRA is a complex piece of legislation that will materially cut some US drug prices. With the IRA newsflow set to amp up, our analysis of the impact on EU Pharma shows that the IRA has a negligible effect on value. We calculate that the IRA negotiations will reduce sector sales by 1.5% by 2030, driving a 4% EBIT impact, but just a ~1% NPV impact. The only concern we have is if pricing in the commercial channel is also affected. We show that in this scenario, where price in commercial is the s...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch