The research and development company has also decided to initiate an expanded access program for TMC114, its investigational protease inhibitor, in the autumn of 2005 for people with HIV/AIDS who need the compound to construct a viable treatment regimen.
Expanded access programs provide people with severe or life-threatening illnesses with access to treatments currently being evaluated in clinical trials.
Initiation of enrollment into the expanded access program which will recruit heavily treatment-experienced adults living with HIV/AIDS is contingent on the approval of local health authorities and recruitment of pivotal phase III trials. Tibotec has already concluded two phase II trials which form the basis of its regulatory submission.
“We know that many people living with HIV/AIDS have run out of treatment options because of the increasingly significant issue of viral resistance, and we are working to provide them with access to TMC114 as soon as possible through this program,” said Dr Paul Stoffels, president of Tibotec.
TMC114 belongs to a class of antiretroviral agents known as protease inhibitors. Protease inhibitors are commonly used in combination with other classes of anti-HIV drugs to prevent the replication of HIV in the body.
The TMC114 expanded access program will be administered by local operating entities within Johnson & Johnson, and will be supported by i3 Research in the US and Parexel outside the US. Pending local regulatory approvals, the product, will be commercialized by Tibotec Therapeutics in the US and Janssen-Cilag and other affiliates outside the US.