ViiV Healthcare receives EU Marketing Authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe

London, 13 January 2021 – ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Commission has granted Marketing Authorisation for Tivicay (dolutegravir) 5mg dispersible tablets, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least four weeks and weighing at least 3kg. This authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10mg, 25mg and 50mg) for children 6 years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “Today’s authorisation is a really important milestone towards enabling children to have access to age-appropriate formulations of HIV medicine. Globally there are approximately 1.7 million children living with HIV and around 100,000 children dying each year from AIDS which is why we won’t stop doing all that we can to ensure that no child living with HIV is left behind.”

The EU Marketing Authorisation follows the US Food and Drug Administration (FDA) approval of Tivicay PD in 20201, providing an age-appropriate formulation of dolutegravir for a younger population to help to close the gap between HIV treatment options available for adults and children.

Amanda Ely, CEO of CHIVA (Children’s HIV Association) said: “As an organisation, we continue our efforts to help support young people and families living with HIV manage the challenges of lifelong treatment and today’s authorisation helps to do this. Today’s news is a positive step forward in helping the many children and infants who may struggle to take their medicines in tablet form.”

The Marketing Authorisation is based on data from the ongoing P10932 and ODYSSEY3 (PENTA20) studies, which are being conducted in collaboration with international paediatric research networks, IMPAACT and PENTA-ID.

Notes to editors:

About P10932 and ODYSSEY3

• P1093 (NCT03016533): a safety, tolerability and dose finding registrational study in paediatric patients aged four weeks to 18 years being conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) network in the USA, Brazil, Thailand, South Africa, Zimbabwe, Kenya and Tanzania. ViiV Healthcare, the Division of AIDS (DAIDS) at the US National Institutes of Health (NIH) are collaborating in this trial.
• ODYSSEY (Penta20) (NCT02259127): a randomised control efficacy trial in first and second- line treatment, in paediatric patients aged four weeks to 18 years being conducted by the PENTA network in Europe, South America, Thailand, Uganda, Zimbabwe, and South Africa. Originally designed to support World Health Organization (WHO) guideline recommendations by WHO weight bands, this study will now also provide data to support revised dosing and continue to 96 weeks. ViiV Healthcare, the Paediatric European Network for Treatment of AIDS (Penta) and the Medical Research Council (MRC) Clinical Trials Unit at University College London for ODYSSEY are collaborating in this trial. For more information, please visit the study website at: http://odysseytrial.org/

Currently 15 generic manufacturers hold voluntary licences for paediatric formulations of DTG: one direct license and 14 through the Medicines Patent Pool (MPP). Two generic manufacturers who hold paediatric dolutegravir sub-licences from the MPP— Mylan Laboratories Limited (Mylan) and Macleods Pharmaceuticals Limited (Macleods) — have been provided with the technical expertise of ViiV Healthcare and a financial incentive from Unitaid via CHAI, to accelerate the development, registration, manufacture and supply of generic dispersible formulations of dolutegravir for children in all low-income, all least developed, all lower-middle income, all Sub-Saharan African (SSA) and some upper middle-income countries as defined by World Bank Classifications at the date of signature of the licence agreement. Mylan and Macleods have both submitted a new drug application for a scored dolutegravir 10mg dispersible tablet with Mylan receiving tentative approval under the FDA President’s Emergency Plan for AIDS Relief (PEPFAR) scheme at the end of 2020.

About Tivicay

Tivicay contains dolutegravir, an integrase strand transfer inhibitor for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors inhibit HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

Important Safety Information (ISI) for TIVICAY (dolutegravir) tablets, for oral use and TIVICAY (dolutegravir) dispersible tablet

The following ISI is based on the highlights section of the Prescribing Information for Tivicay. These highlights do not include all the information needed to use TIVICAY safely and effectively. See full prescribing information for TIVICAY.

Indications and Usage

TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in paediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least 4 weeks and weighing at least 3 kg.

TIVICAY is indicated in combination with rilpivirine as a complete regimen 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 or known substitutions associated with resistance to either antiretroviral agent.

Contraindications

• Previous hypersensitivity reaction to dolutegravir.
• Coadministration with dofetilide.

Warnings and Precautions

• Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported. Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction.
• Hepatotoxicity has been reported in patients receiving dolutegravir-containing regimens. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations. Monitoring for hepatotoxicity is recommended.
• If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
  • Talk to your doctor about the risks and benefits of taking TIVICAY.
• Taking TIVICAY at the time of becoming pregnant or during the first six weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
• If you could get pregnant while receiving TIVICAY:
  • Talk to your doctor and discuss whether there is a need for contraception, such as condom or pills
• Tell your doctor immediately if you become pregnant or are planning to become pregnant. Your doctor will review your treatment. Do not stop taking TIVICAY without consulting your doctor, as this may harm you and your unborn child.
• Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.
• TIVICAY tablets and TIVICAY dispersible tablets are not interchangeable.

Adverse Reactions

• The most common adverse reactions of moderate to severe intensity and incidence at least 2% (in those receiving TIVICAY in any one adult trial) are insomnia, fatigue, and headache.

Drug Interactions

• Refer to the full prescribing information for important drug interactions with TIVICAY.
• Drugs that are metabolic inducers may decrease the plasma concentrations of dolutegravir.
• TIVICAY should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. When taken with food, TIVICAY and supplements containing calcium or iron can be taken at the same time.

Use in Specific Populations

• Pregnancy: An alternative treatment to dolutegravir should be considered at the time of conception through the first trimester due to the risk of neural tube defects.
• Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission.
• Individuals of reproductive potential: Pregnancy testing and contraception are recommended in adolescents and adults of childbearing potential.

Please see full prescribing information available at:

https://www.medicines.org.uk/emc/product/5248/smpc#gref

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 aims are 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.

About GSK

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

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principle risks and uncertainties” section of the Q3 Results and any impacts of the COVID-19 pandemic.

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