The US FDA is currently conducting a full cGMP inspection of Chiron's Liverpool facility, which manufactures Fluvirin influenza virus vaccine. Following the on-site inspection, Chiron expects to respond to any observations noted by the FDA. Chiron expects that the FDA will then assess Chiron's response in conjunction with the agency's findings, Chiron Corporation has announced here.

Chiron currently expects to produce 18 to 26 million doses of Fluvirin vaccine for the 2005-2006 influenza season, with the vast majority of the supply going to the US market. In addition to the facility inspection, Chiron will need to receive supplemental approvals for changes in its product from the Medicines and Healthcare products Regulatory Agency (MHRA) and FDA because of variations to its manufacturing process. The Centre for Biologics Evaluation and Research (CBER), a division of the FDA, validates and releases Fluvirin vaccine for the US market.

Meanwhile, Chiron has received an action letter from the US FDA stating that the company's New Drug Application (NDA) for Pulminiq (cyclosporine, USP) inhalation solution is "approvable" but that an additional pre-approval study is required to confirm the efficacy of the drug. In the NDA for Pulminiq, Chiron is seeking an indication to increase survival and prevent chronic rejection in patients receiving allogeneic lung transplants, in combination with standard immunosuppressive therapy. Chiron is evaluating possible next steps for Pulminiq.

"Chiron in-licensed Pulminiq knowing the significant regulatory challenges associated with a single-centre trial with a small patient population. We took on these challenges because we believe strongly in the data for Pulminiq," said Craig Wheeler, president, Chiron BioPharmaceuticals.