History

1995
Phase III Trials; Production Facilities Begun

Edward Scolnick, head of Merck’s research labs, approached company CEO Raymond Gilmartin about Phase III testing, the final step before seeking FDA approval and starting plans for full-scale production. Using just the results from the Phase II studies — studies that they now knew involved suboptimal doses of CRIXIVAN — Merck senior management gave the green light to Phase III trials and to start planning for large-scale production facilities. Just 2 months later, Merck started to build the new construction facilities — even before the Phase III trials started in April 1995.

It was a costly proposition. The drug was taken in large doses, about a kilogram a year per patient, and manufacturing enough for an extensive worldwide trial would require that Merck’s large-scale operations plant in Rahway NJ and other facilities be fully dedicated to CRIXIVAN. Additionally, pressure was increasing from the AIDS activist community to begin a compassionate use program for CRIXIVAN in order to get what many in the community believed might be a life-extending treatment to patients who were dying. Meeting again with members of the community advisory board, Merck agreed to manufacture enough extra CRIXIVAN to allow for a compassionate use program for 1,400 patients, 1,000 of whom were to be selected through a lottery. More than 11,000 requests came in for the compassionate use program.