Glaxo and Pfizer signal new approach to HIV drug research and development

GlaxoSmithKline (GSK) and Pfizer are spinning out all HIV/AIDS-related R&D and marketed drugs into a separate, jointly-controlled company.

The move signals a new approach to tackling the huge unmet medical need in this notoriously difficult area of science. The new, as yet unnamed, company starts life with a turnover of £1.6 billion and operating profits of £870 million. It will be 85 per cent owned by Glaxo and 15 percent by Pfizer and will focus solely on research, development and commercialisation of HIV/AIDS medicines. Its parents said the new entity will be more sustainable and broader in scope than either company’s individual effort, controlling 19 per cent of the global market.

Andrew Witty, CEO of GSK, said the move would renew the London-based company’s focus on HIV/AIDS. “At the core of this specialist business is a broad portfolio of products and pipeline assets, which can be more effectively leveraged through the new company’s strong revenue base and dedicated research capability.”

The HIV company will have a broad product portfolio of 11 marketed products including Combivir, Kivexa and Selzentry/Celsentri and a development pipeline of six products, including four compounds in Phase II development. In total, the new company will have 17 molecules at its disposal to develop in fixed-dose combinations as possible new HIV treatments. A head of R&D will be appointed to oversee all activity, but the new company will contract R&D services directly from GSK and Pfizer.

The new company will also invest in early-stage research and discovery of HIV drugs as part of a new Research Alliance Agreement with GSK and Pfizer. Under this alliance, GSK and Pfizer will continue to conduct discovery research and development, with the new company having exclusive rights of first negotiation to any new HIV-related medicine developed by either parent.

Not-for-profit pricing for HIV medicines will continue for those countries most in need, and the new company will continue to facilitate new voluntary licences to diversify production and expand capacity in these markets.

The new company will also conduct research and development activities specifically to address appropriate access to HIV medicines in developing countries. In particular, the new company will increase its research effort into treatments and formulations for children living with HIV.

GSK and Pfizer have established an integration steering committee to prepare for the operation of the new company. A head of R&D will be appointed to oversee all research and development activities. Manufacturing and other services will be provided by GSK and Pfizer.