MEDIA ADVISORY UPDATE
BOSTON, MA, December 8, 2006 — The Expert Scientific Group (ESG), which was established following the TeGenero Phase I study and convened by the Secretary of State for Health in the United Kingdom, yesterday released its final report on Phase I clinical trials. The report presents guidelines and recommendations regarding the future conduct of Phase I clinical trials. PAREXEL looks forward to adopting any changes that are ultimately approved by the government and implemented by the bio/pharmaceutical industry.
In May, following a highly detailed review and thorough audit of the Phase I study regarding TeGenero’s drug, the Medicines and Healthcare products Regulatory Agency (MHRA) issued its final report, which may be found at: www.mhra.gov.uk. The report concluded that nothing PAREXEL did contributed to the adverse reactions experienced by the study participants.
PAREXEL’s top priority from the beginning has been the health and well-being of the participants in the TeGenero Phase I study and their families. TeGenero, the drug developer and sponsor of the clinical study, is insolvent. However, the full value of TeGenero’s insurance policy continues to be available to compensate the study participants. PAREXEL will continue to facilitate access to this compensation for the participants.
PAREXEL will not be issuing any further statements, unless there are significant developments.