Glaxo-Pfizer JV offers free access to new HIV/AIDS medicines to low-cost generic makers in poorer nations

People living with HIV/AIDS in the least developed nations will now be able get the low-cost versions of the new generation anti-retrovirals as the world’s top drug makers GlaxoSmithKline and Pfizer have offered licence free access to their drug pipeline.

ViiV Healthcare, a joint venture of GlaxoSmithKline and Pfizer’s for AIDS drugs, announced a royalty-free offer to generic firms in 69 poor countries, including all sub-Saharan Africa.Sub-Saharan Africa has 80% of all people currently living with HIV.

ViiV offer includes licences for all current and pipeline products.

The new series of initiatives to support people living with HIV/AIDS in the poorest and most vulnerable countries, ViiV said in a press statement.

To address the evolving treatment needs in these countries, people living with HIV/AIDS will now be able to access the whole portfolio of ViiV Healthcare antiretroviral medicines, produced by generic companies.

ViiV Healthcare is also making all patents available to generic manufacturers in these countries for all future pipeline developments, such as the novel integrase inhibitor jointly under development Shionogi – ViiVHealthcare, LLC.

“At present the numbers of people in the least developed countries moving onto second line therapy is very low compared to the developed world. However as more people have access to treatment, there is an increased need for second and third line treatment options once initial treatment failure occurs.” stated Dr Dominique Limet, CEO of ViiV Healthcare.

This is the reason for ViiV to make the entire portfolio and the pipeline products available through royalty-free voluntary licensing and not-for-profit initiatives, he added.

Voluntary licences are granted by patent holders to allow a generic company to manufacture and sell versions of their products.

ViiV Healthcare will now make these available, royalty free, to generic companies for all of their current portfolio, including the newer innovative products as well as future pipeline developments.

ViiVHealthcare has acknowledged the contribution of Shire Pharmaceuticals Group plc, which has a Master Licence agreement with ViiVHealthcare, for products containing lamivudine; and of Shionogi co-developer of the integrase inhibitor with ViiVHealthcare that have also agreed to waive its rights to royalty payments in order to improve access for these products.

ViiV Healthcare also has a number of other key initiatives to support further access to therapies in the areas worst hit by the epidemic.

The Not for Profit Price commitment for our ARV portfolio to government and international procurement agencies such as the Global Fund for AIDS, Tuberculosis and Malaria and UNICEF has also been expanded to these 69 countries.

It has also set up a £10 million seed fund to support access to care and treatment for infants and children and to generate evidence for paediatric fixed dose combinations and formulations.

The Positive Action for Children Fund (PACF) and Positive Action programmes which support a community response to the epidemic. £3.6 million of new grants were announced by the PACF Independent Fund Advisory Board in Kenya supporting twelve projects in eight countries on 30th June 2010.

GSK holds an 85 percent interest in the ViiV Healthcare and Pfizer holds 15 percent. GSK and Pfizer announced that they had agreed to form a new specialist HIV company on April 16, 2009. The transaction was completed on October 30, 2009. ViiV Healthcare launched on November 3, 2009.

The new free licence programme applies to the Least Developed Countries (34 Africa, 14 Asia and Pacific, 1 Western Asia (Yemen), I Caribbean (Haiti)) – categorised on a variety of factors including poverty, structural weakness, landlocked, island state, limited capacity for growth, extreme vulnerability to external shocks and the Low Income Countries as defined by the World Bank not included by this list and all of sub-Saharan Africa.

The countries to get benefit are: Afghanistan, Angola, Bangladesh, Benin, Bhutan, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Cote d’Ivoire, Djibouti, DR Congo (Zaire), East Timor, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Ghana, Gambia, Guinea, Guinea Bissau, Haiti, Kenya, Kiribati, Lao People’s DR, Lesotho, Liberia, Madagascar, Malawi, Maldives, Mali, Mauritania, Mauritius, Mozambique, Myanmar, Namibia, Nepal, Niger, Nigeria, North Korea, Republic Kyrgyz, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, Sudan, Swaziland, Tanzania, Tajikistan, Togo, Tuvalu, Uganda, Uzbekistan, Vanuatu, Vietnam, Yemen, Zambia, Zimbabwe.