GSK submits regulatory application for chlorhexidine gel for the prevention of umbilical cord infections in newborn babies

Issued: London

- Antiseptic gel developed in response to United Nations call for chlorhexidine products suitable for newborn babies

- Regulatory submission marks a major milestone in the GSK and Save the Children partnership which combines expertise and resources to help save the lives of children in developing countries

GSK today announced that it has submitted a regulatory application to the European Medicines Agency (EMA) for its antiseptic chlorhexidine gel (7.1% chlorhexidine digluconate gel, equivalent to 4% chlorhexidine) for the prevention of umbilical cord infections (omphalitis) in newborn babies. GSK’s work to develop the gel began in response to a call from the United Nations (UN) in 2012 for manufacturers to make a high quality chlorhexidine product suitable for newborn infants in low resources settings.

The EMA has granted the application accelerated assessment, a process open to medicinal products of major public health interest and under which the EMA intends to provide a scientific opinion on the submission in a reduced timeframe of 150 days. The antiseptic gel is intended exclusively for use in developing countries and, if approved for use, GSK will offer it at a not-for-profit price and will share its manufacturing knowledge with others to enable it to be made locally.

Each year, approximately three million newborns die worldwide within the first 28 days of life, a quarter due to infection.¹ A newly-cut umbilical cord acts as an entry point for the bacteria which can lead to newborn infection, sepsis and death. Umbilical cord infections are more likely to occur in low income settings; primarily in developing countries across Africa and South Asia where a high proportion of births take place at home. In 2012, a United Nations (UN) Commission Report identified chlorhexidine for newborn cord care as one of 13 overlooked ‘life-saving commodities’ that, if more widely accessed and properly used, could potentially save 422,000 neonatal lives over 5 years.²

In response, GSK has worked to reformulate the antiseptic chlorhexidine solution used in GSK’s Corsodyl™ mouthwash into an antiseptic gel, using insights and on-the-ground knowledge from Save the Children. The new gel formulation has been optimised to be stable in regions of high heat and high humidity with no cold chain storage and is presented in single-use sachets. This gel project is a major aspect of the GSK and Save the Children partnership, established in 2013, which aims to combine the resources and expertise of both organisations to help save the lives of a million children around the world.

Dr Pauline Williams, Head of Global Health R&D in GSK said: “We are delighted to have reached this significant milestone, which brings us a step closer to help protect newborns from umbilical cord infection. The combination of GSK’s scientific, regulatory and manufacturing capabilities and Save the Children’s on-the-ground knowledge presented us with a unique opportunity to develop a medicine, by reformulating an existing product, to meet a priority need for newborns in developing countries.”

Simon Wright, Head of Child Survival at Save the Children said: “The filing of chlorhexidine is an exciting step forward in our goal to help prevent newborn deaths. This formulation has been designed with some of the toughest settings in mind and, crucially, GSK is not looking to make a profit or even recoup their investment in research and development. Instead they want to offer this to other manufacturers to develop as a sustainable business.”

The GSK’s regulatory submission for its chlorhexidine gel will follow the Article 58 procedure, which allows the EMA to assess the quality, safety and efficacy of a medicine for a disease recognised by the World Health Organization (WHO) as a major public health interest, but intended exclusively for use outside of Europe. This assessment is undertaken by the EMA, in collaboration with the WHO, and requires applicants to meet the same standards as medicines or vaccines intended for use in the EU.

Data from three large published community-based randomised controlled trials of 4% aqueous chlorhexidine solution in Nepal,³ Bangladesh⁴ and Pakistan⁵ have been included to support the filing. A meta-analysis of these studies indicated that chlorhexidine, versus dry cord care, soap and water or hand washing, delivered a 23% reduction in all-cause newborn mortality.⁶ Further, a non-inferiority randomised controlled trial in Nepal⁷ showed a 7.1% chlorhexidine digluconate gel formulation was non-inferior to the aqueous solution in reducing bacterial colonisation of the umbilical cord stump.

If a positive scientific opinion from the EMA is granted in 2016, GSK will request a Certificate of Pharmaceutical Product (CPP) which is an integral part of the marketing authorisation applications to National Regulatory Authorities (NRAs) in countries with regions of moderate-high neonatal mortality rates.

Since 2013, Save the Children has been a member of GSK’s Maternal and Neonatal Health R&D Advisory Board, helping GSK to shape its research activities and development of medicines for mothers and infants.

Notes to Editors

About chlorhexidine

• 7.1% chlorhexidine digluconate gel (equivalent to 4% chlorhexidine) is intended exclusively for use against newborn umbilical cord infections in developing countries
• A UN Commission Report, on Life-saving Commodities for Women and Children, identified chlorhexidine for newborn cord care as one of 13 overlooked life-saving commodities²
• In January 2014, the WHO updated its guidelines on postnatal care of the mother and newborn and recommended the application of daily 7.1% chlorhexidine digluconate to the umbilical cord stump during the first week of life for newborns born at home in settings with high neonatal mortality rates (30 or more neonatal deaths per 1000 live births)⁸
• 7.1% chlorhexidine digluconate is being added to the Essential Medicines List in many developing countries for neonatal care

About Save the Children – Save the Children works in more than 120 countries and helps to save children’s lives, fight for their rights and help them to fulfil their potential. For more information visit: www.savethechildren.org.uk

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 our about us section.

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 2014.

References

¹ Unicef. Levels & Trends in Child Mortality. Report 2014
² United Nations. UN Commission on life-saving commodities for women and children. 2012 [URL last accessed 6 October 2015: http://www.unicef.org/media/files/UN_Commission_Report_September_2012_Final.pdf]
³ Mullany LC, et al. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet 2006;367(9514):910-918
⁴ Arifeen Se, et al. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet 2012;379(9820):1022-1028.
⁵ Soofi S et al. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet 2012;379(9820):1029-1036
⁶ Imdad A, et al. The effect of umbilical cord cleansing with chlorhexidine on omphalitis and neonatal mortality in developing country communities: a meta-analysis. BMC Public Health 2012;13 Suppl 3:S15
⁷ Hodgins S et al. Chlorhexidine gel versus aqueous for preventive use on umbilical stump. Pediatr Infect Dis J 2010;29:999-1003
⁸ World Health Organization. WHO Recommendations on Postnatal Care of the Mother and Newborn. 2013. [URL last accessed 6 October 2015: http://apps.who.int/iris/bitstream/10665/97603/1/9789241506649_eng.pdf]