FAST-TRACK STATUS GRANTED FOR HIV INHIBITOR

Vertex Pharmaceuticals announced that its collaborator, GlaxoSmithKline, has received fast-track designation for the HIV protease inhibitor (PI) 640385 (VX-385) from the FDA. GSK plans to initiate a Phase IIb study of 640385 in HIV- infected patients in the third quarter of 2005. 640385 is the third, orally active HIV PI to be developed as part of the collaboration agreement between Vertex and GSK.

Under the FDA Modernization Act of 1997, fast-track designation indicates that the FDA will facilitate the development and may expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and demonstrates the potential to address an unmet medical need for such a condition. Support of this fast-track designation was based on positive Phase IIa data from a clinical study of 640385 in HIV-infected patients, as well as results from in vitro studies indicating 640385's antiviral activity against HIV-1 strains resistant to a number of currently marketed protease inhibitors.