MHRA lifts Chiron flu suspension

Chiron Corporation has received notice from the UK Medicines and Healthcare products Regulatory Agency (MHRA) that the agency has lifted the license suspension for Chiron's Liverpool manufacturing facility, which produces Fluvirin influenza virus vaccine.

The notice, which follows MHRA inspections of the Liverpool facility, states that: 'it is the opinion of the Licensing Authority that (Chiron is) now in a position to conduct (its) operations in accordance with the principles and guidelines of Good Manufacturing Practices (GMP).' The decision is conditioned on the understanding that Chiron's high level of commitment to the completion of its remediation plan and ongoing improvements will continue. Chiron will provide the MHRA with regular weekly updates to ensure that progress on its various projects proceeds satisfactorily, and the MHRA may conduct further inspections. Chiron now has clearance to initiate full production of Fluvirin vaccine.

'We are grateful for the guidance and effort from the regulatory agencies as we have navigated a path toward remediation,' said Howard Pien, ceo of Chiron. 'Our employees have worked tirelessly and we are extremely proud of this result. This is a significant accomplishment. In this new beginning we remain focused on continuing to remediate and improve so Chiron can successfully deliver on the results required to supply influenza vaccine for the 2005-2006 season.'

Chiron anticipates that the FDA will conduct a full cGMP inspection to allow resolution of the warning letter issued in December 2004.