The company is conducting an investigation to determine the root cause of this failure and believes that it is likely related to the higher than expected moisture content within the vial. Based on tests conducted, the company believes that the issue is related to either the lyophilization process or the equipment.
Auxilium stated that it has not received any reports of adverse reactions from the ongoing phase III trials and that the clinical trial investigators would continue to monitor patients already dosed in accordance with the trial protocols.
“We know that the manufacture of biologics is complex and our team of experts will endeavor to complete the root cause investigation as soon as possible in order to implement corrective actions so that we can resume the phase III trials,” said Armando Anido, CEO and president.