GSK and BI to develop Combivir and Viramune co-package

GlaxoSmithKline (GSK) and Boehringer Ingelheim have signed a letter of intent for an accelerated development programme for a co-package for Combivir (lamivudine/zidovudine) and Viramune (nevirapine) for chronic treatment of HIV infection in the developing world.

Given the complexities of providing HIV care and treatment in the developing world, GSK and Boe-hringer Ingelheim support efforts to simplify treatment regimens and improve access to antiretrovirals (ARV) to people living with HIV.

The companies have initiated contact with the FDA on development of the co-package under the new draft FDA guidance designed ultimately to increase treatment options for HIV in the developing world. The availability of the Combivir-Viramune co-package is contingent upon approval by appropriate regulatory authorities and execution of a definitive agreement.

'We have made substantial progress with our strategy to co-package Combivir and Viramune,' said Dr Lynn Marks, senior vice president of Infectious Diseases, GSK. 'We continue our commitment to address the HIV/AIDS challenges in the developing world. Both companies believe that patients can benefit from a co-package that simplifies treatment.'

'The co-package of Viramune and Combivir is the most expeditious strategy for facilitating access to HIV treatment in the developing world. In practice, the Viramune- Combivir co-package will facilitate distribution and delivery of a recognised triple therapy to patients in need.' said Dr. Alessandro Banchi, chairman of the board of managing directors at Boehringer Ingelheim.

The Combivir and Viramune combination regimen is a well-established, safe and effective treatment for HIV. This combination is recommended by the World Health Organisation as a first-line regimen in its treatment guidelines for developing countries published in December 2003.