Tibotec Pharmaceuticals confirms expanded access programme

Tibotec Pharmaceuticals, a Johnson & Johnson company, has confirmed that the expanded access programme has opened in the US for its TMC125 investigational agent.

The programme, which is also due to open in Canada and European once approval is granted, will provide access for HIV-1 infected patients needing such an agent to construct viable treatment regimen.

Tibotec’s announcement builds on phase III clinical trials in treatment-experienced HIV-1 infected patients which have completed enrolment and are currently ongoing, though its safety and efficacy in combination with antiretroviral agents has not been confirmed.

Roger Pomerantz, president of Tibotec research and development stated: “We know that many people living with HIV/Aids have limited treatment options because of the increasingly significant issue of viral resistance, and we are working to provide eligible individuals with access to TMC125 as soon as possible through this program.”

The TMC125 EAP means it is available to HIV-1 infected adults who are at least 18 years old and who have limited treatment options.

In April 2002 Tibotec Pharmaceuticals along with Virco were acquired by Johnson & Johnson.