GlaxoSmithKline and the World Health Organization
(WHO) today announce that they have signed an agreement for the
development of a new treatment for malaria called LAPDAP.
LAPDAP, a product that combines two existing
anti-malarial compounds chlorproguanil and dapsone, is a potential
life-saving medicine. The aim of the agreement is to develop LAPDAP as
an effective oral treatment for uncomplicated malaria, primarily for use
in Sub-Saharan Africa, but also in other regions of the world where this
may be appropriate. To date, clinical trials in Sub-Saharan Africa have
demonstrated that LAPDAP is effective in the treatment of uncomplicated
malaria including malaria resistant to other standard first line
therapies such as chloroquine and sulphadoxine/pyrimethamine (SP).
LAPDAP will be made available at a preferential price
for public health programmes. The medicine is already entering its final
phase of development and could be available in some African countries as
early as next year.
Both partners have contributed towards the costs of
product development and have set up a joint team to oversee the
development of the product. Other important supporters of this initiative include the UK Department for International
Development (DfID) and the University of Liverpool, UK.
"GlaxoSmithKline firmly believes that the
complex issues associated with meeting the healthcare needs of
developing countries will only be resolved through collaborative
effort," said Jean-Pierre Garnier, Chief Executive Officer,
"The LAPDAP programme further demonstrates this
new company's determination to play its part in improving healthcare
world-wide and in finding innovative and practical ways of providing
much needed new medicines to people in developing countries."
Dr Gro Harlem Brundtland, Director General of the
World Health Organization said: "Drug resistance means that large
populations in many parts of the world are without protection from
malaria. LAPDAP will be an important help in reducing the burden of
malaria among those living in Sub-Saharan Africa and elsewhere. This
agreement shows that public-private partnerships can achieve important
practical results. It is an important collaboration not only because it
will bring a new drug to the market, but also because it includes a
price structure that aims at making the drug affordable for those who
WHO, by means of its UNDP/World Bank/WHO Special
Programme for Research and Training in Tropical Diseases (TDR), is
arranging and providing considerable financial support for clinical
trials of LAPDAP. In addition, WHO is making available its technical
expertise, especially in the area of malaria clinical trials, to the
development team. TDR’s expertise and the knowledge and experience of
the WHO-led "Roll Back Malaria" partnership will also be
available as the programme proceeds beyond regulatory approval.
GlaxoSmithKline will be responsible for product
registrations and manufacture of LAPDAP. The company will also
commercialise the product in the private sector according to standard
local market practice.
The UK Department for International
Development (DfID) provided funding to advance the
project while the University of Liverpool, UK, devised the concept of
LAPDAP in the early 1990s, and have continued to be major contributors
to the programme. The Product Development Team is chaired by Professor
Peter Winstanley of The University of Liverpool.
The partnership intends to extend their collaboration
to develop LAPDAP in combination with an artemisinin derivative, in
order to extend further the useful life of the new medication.
Malaria is a serious, sometimes fatal, disease. At
least 300 million clinical cases occur world-wide every year, 90 percent
of which are in Africa. Every day close to 3000 people, mostly children
under five, die as a result of this disease.