Issued: Thursday 24 July 2014, London UK

GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.

The submission will follow the Article 58 procedure, which allows the EMA to assess the quality, safety and efficacy of a candidate vaccine, or medicine, manufactured in a European Union (EU) member state, for a disease recognised by the World Health Organization (WHO) as of major public health interest, but intended exclusively for use outside the EU. This assessment is done by the EMA in collaboration with the WHO, and requires products to meet the same standards as vaccines or medicines intended for use in the EU. Eligibility for the application was granted by the CHMP after agreement from WHO that RTS,S met criteria for such an evaluation.

RTS,S is intended exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). Around 90 per cent of estimated deaths from malaria occur in SSA, and 77 per cent of these are in children under the age of 5.

The EMA submission is the first step in the regulatory process toward making the RTS,S vaccine candidate available as an addition to existing tools currently recommended for malaria prevention. An effective vaccine for use alongside other measures such as bednets and anti-malarial medicines would represent a advance in malaria control. To-date there is no licensed vaccine available for the prevention of malaria.

If a positive opinion from the EMA is granted, the WHO has indicated a policy recommendation may be possible by end of 2015. A policy recommendation is a formal review process by WHO designed to assist in the development of optimal immunisation schedules for diseases that have a global public health impact, such as malaria.[i]

A positive opinion from the EMA would also be the basis for marketing authorisation applications to National Regulatory Authorities (NRAs) in SSA countries. A review by a European medicines agency is required by the majority of African countries prior to registration of a medicinal product manufactured in Europe. If positive, these regulatory decisions would help pave the way toward the large-scale implementation of the vaccine through African national immunisation programmes.

Dr Sophie Biernaux, Head of the Malaria Vaccine Franchise, GSK said: “This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria.”

Data from the phase III vaccine trial programme conducted at 13 African research centres in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania) including over 16,000 infants and young children have also been included to support the filing.

Notes to Editors

About RTS,S

• RTS,S is the scientific name given to this malaria vaccine candidate and reflects the composition of this vaccine candidate that also contains the AS01 adjuvant system[ii].
• RTS,S aims to trigger the body’s immune system to defend against the P falciparum malaria parasite when it first enters the human host’s bloodstream and/or when the parasite infects liver cells.
• The vaccine is designed to prevent the parasite from infecting, maturing and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms. In the phase III efficacy trial, RTS,S was administered in three doses, one month apart.
• GSK has taken the lead in the overall development of RTS,S and has invested more than $350 million to date and expects to invest a further $260 million until development is completed. With more than US$200 million in grant monies from the Bill Melinda Gates Foundation, the PATH Malaria Vaccine Initiative (MVI) contributes financial, scientific, managerial, and field expertise to the development of RTS,S.
• GSK has committed that the eventual price of RTS,S will cover the cost of manufacturing the vaccine together with a small return of around 5 per cent that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

[i] WHO policy recommendations overview found at: http://www.who.int/immunization/policy/en/. Accessed May 2014.

[ii] The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.