Chiron gains as flu license reinstated

The timing of the license renewal for the company’s Liverpool, UK manufacturing facility has come as a sign of relief to many in the company as it means Chiron may be able to play a part in the coming flu season. The news has already benefited not only Chiron’s shares, but also those of Fluvirin distributor Henry Schein, which has seen its shares grow by more than 5%.

The reinstatement notice, which follows the Medicines and Healthcare products Regulatory Agency (MHRA)’s 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).”

Although Chiron now has clearance to initiate full production of Fluvirin vaccine, the company must provide the MHRA with regular weekly updates to ensure that progress on its various projects proceeds satisfactorily, and the MHRA may conduct further inspections.

“This is a significant accomplishment,” said Howard Pien, CEO of Chiron. “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.”

The FDA and MHRA will now continue to closely monitor Chiron’s progress as manufacturing proceeds. When all critical stages of manufacturing are in full swing, and corrective actions can be fully evaluated, the FDA plans to conduct a comprehensive inspection of the Liverpool facility to assure that Chiron can produce a safe and effective vaccine for US supplies.