GlaxoSmithKline (GSK) and the UK Health Protection Agency (HPA) have announced a deal for the development and manufacture of a "next generation" polio vaccine which, they say, will make "an incredible impact on global public health."Global polio eradication will require the eventual cessation of oral polio vaccine (OPV) and the introduction of inactivated polio vaccine (IPV) worldwide. Post-eradication, vaccination against polio will have to continue with IPV, and one solution to ensure and maintain this transition longer-term is the opportunity to develop the next-generation vaccines strains developed by HPA to produce IPV in developing countries, the partners note.
Researchers at HPA's National Institute for Biological Standards and Control (NIBSC) have developed genetically-stable strains, allowing a simpler process for production of inactivated polio vaccines in developing countries. This approach, and biological materials, are now protected under two patent families and associated know-how.
The HPA technology should enable the polio vaccine to be manufactured in developing countries, be cheaper to make and affordable for mass vaccination in these nations, says the Agency.The non-exclusive, material transfer, patent and know-how license agreement deal which it has now agreed with GSK - and such future licensing agreements - will allow the Agency to contribute to global polio eradication while securing commitment from a major company in order to develop the use of its unique technology, says HPA. The terms include certain milestones and tiered royalty payments to the Agency in return for technology transfer and other licensing rights.
"Polio in the UK is a disease of the past thanks to an effective and highly successful immunisation programme; however, it is still a danger to millions of children in countries where the disease has not yet been eradicated, and can cause paralysis and even death," commented Dr David Rhodes, head of business development at HPA.
"As there is no cure for polio, it is important to prevent it from occurring through vaccination. This new technology provides a unique opportunity for developing countries that have the capability to use this new technology to manufacture polio vaccines which will make an incredible impact on global public health," said Dr Rhodes.- This month, the HPA becomes part of Public Health England, a new executive agency of the Department of Health, while the NIBSC is now a centre of the Medicines and Healthcare Products Regulatory Agency (MHRA), alongside the Clinical Practice Research Datalink (CPRD).
MHRA notes that it has worked closely together with NIBSC for many years, and that they have common interests in managing risks associated with biological medicines, facilitating development of new medicines safely and effectively, and maintaining UK expertise and ability to contribute to assuring the quality and safety of medicines in Europe and beyond.
NIBSC is the global leader in the field of biological standardisation, responsible for developing and producing over 90% of the international standards in use around the world to assure the quality of biological medicines, says MHRA. "NIBSC scientists have an international reputation for excellence in research and are widely consulted on issues of biological medicine safety and efficacy," it notes.
The Institute is also the UK's Official Medicines Control Laboratory (OMCL), responsible for testing of biological medicines within the framework of the European Union (EU). It has a particularly close relationship with the World Health Organisation (WHO) and is the leading WHO International Laboratory for Standards, adds MHRA.