Astrazeneca to Overhaul Clinical Processes

STRATEGY

AstraZeneca CEO Sir Tom McKillop has launched an overhaul of his company's clinical and regulatory drug development regime. The move follows news that FDA may remove AstraZeneca's cancer drug Iressa (gefitinib) from the market in light of clinical test results that show it failed to prolong the lives of patients with advanced lung cancer.

The move also follows FDA's rejection of the company's blood-thinning drug Exanta (ximelagatran) in October and questions regarding the safety of Crestor (rosuvastatin), the company's cholesterol-lowering drug, aired during congressional hearings last month.

McKillop has appointed Executive Vice President John Patterson to the newly created board position of executive director responsible for development. Patterson, he says, is charged with implementing substantial changes in clinical organization and processes and with improving regulatory capabilities and interactions with regulatory authorities.

"These recent disappointments, set in a more hostile environment toward pharmaceutical stocks, have resulted in a substantial loss of value," McKillop says. "I am determined to improve our development and regulatory performance and restore confidence in the company and value to shareholders."

Iressa received expedited FDA approval in May, pending results of clinical trials. FDA is facing increased criticism of its assessment of safety risks during the drug approval process and of its safety monitoring of drugs on the market.