Public-private partnerships for drug development: An emerging trend or special cases?
On November 5th 2007 the pharmaceutical company GlaxoSmithKline (GSK) announced that it had formed a five year alliance with the Texan based non-profit research institution MD Anderson Cancer Center to discover and develop new therapeutic, diagnostic and imaging products for cancer. According to the company the objective of the partnership is to get scientists from both organisations working together early in the discovery and development process to reduce delays in drug approval process.
This strategy diverges from the more typical approach of pharmaceutical companies who typically start to work with clinical centers like the MD Anderson Center only once they have obtained approval of investigational new drugs (IND) from the U.S. Food and Drug Administration. GSK's alliance with the MD Anderson Cancer Center involves getting each institution's scientists working together early in the process to monitor progress in research and development and to select biomarkers and imaging techniques in advance of an IND approval so that clinical trials can be launched with immediate effect when given the go ahead by the FDA. Given the fact that time is often one of the most expensive factors in clinical trials, this could provide a useful means cutting down on the costs of clinical development and help flag problems early on.
The alliance with MD Anderson Cancer Center is part of a trend for GSK which has entered a number of public/private partnerships in recent years. In 2000 the company entered a partnership to develop a malaria vaccine for children with the Malaria Vaccine Initiative (MVI), an organisation started by the Bill & Melinda Gates Foundation in 1999. By 2004 clinical trials were showing promising results for a malaria vaccine candidate produced from the partnership. In 2003 GSK began marketing Lapdap, a drug directed towards the most life-threatening malaria parasite, which had been developed through a public/private partnership begun in 1993 between GSK, the Tropical Disease Research Programme of the World Health Organization, the UK Government's Department for International Development, the University of Liverpool, the Liverpool School of Tropical Medicine.
In 2005 GSK entered another public/private partnership with the International AIDS Vaccine Initiative (IAVI) to develop an AIDS vaccine. The aim of the collaboration was to support early research and development of a new technology developed at the University of Pennsylvania exclusively licensed to GSK which uses non-infectious vaccine vectors to stimulate specific immune responses directed against HIV. Under the terms of the alliance GSK and IAVI researchers were to form a joint research and development team and IAVI was to contribute technical expertise and funding.
GSK's partnerships with public organisations are not unique. In 2005 the pharmaceutical company Bayer Healthcare entered an alliance with the non-profit organisation Global Alliance for TB Drug Development to study the potential of Bayer's antibiotic, moxifloxacin, to reduce the standard 6-month treatment of tuberculosis to 2-3 months. In 2004 the swiss based pharmaceutical company Novartis entered an alliance with the Broad Institute of MIT and Harvard and the Lund University to form the Diabetes Genetics Initiative with the aim of deciphering the genetic causes of type 2 diabetes. In February 2007 the partnership released on the web the data of the genome-wide analysis of genes associated with type 2 diabetes and other related metabolic disorders.
With patents expiring, product pipelines drying up, spiraling development and clinical costs and a hostile press, public/private partnerships offer an attractive strategy for pharmaceutical companies to improve their image and reduce costs. Public/private partnerships are unlikely to improve a company's profit revenues in the short-term, however, because they are more likely to occur where the public has a vested interest in a specific disease which affects the poor. For public institutions they offer an important means of co-ownership and lowering the cost of medicines.
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