Triangle NDA likely to be delayed

VIRS said an NDA submission for its Coviracil emtricitabine probably will be delayed. The announcement follows discussions with the FDA indicating that data from VIRS's FTC-302 South African Phase III trial will not be sufficient to support an NDA approval. As a result, VIRS will reduce its workforce by about 35% by eliminating 54 full-time employees and 31 full and part time contractors in order to lower its cash burn rate and focus on developing its late stage clinical products.

The FTC-302 trial was temporarily halted last year due to a high incidence of liver toxicity in a set of patients treated with Coviracil, and VIRS noted at the time that the FDA clinical hold could render the trial results inadequate to support and NDA (see BioCentury, Feb. 12 and April 10, 2000). VIRS said it probably will need to include data from its ongoing FTC-301 Phase III study of Coviracil (FTC-301), in which it expects to complete enrollment in October. VIRS also said it expects to file for European approval in the first half of next year. ...