The UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA) has temporarily suspended Chiron Corporation's license to manufacture Fluvirin influenza virus vaccine in its Liverpool facility, preventing the company from releasing any of the product during the 2004- 2005 influenza season.
Earlier, Chiron anticipated that the regulatory review process would be satisfactorily completed in time to allow release of Fluvirin in early October. However, MHRA has asserted that Chiron's manufacturing process does not comply with UK Good Manufacturing Practices regulations and has suspended the company's Liverpool facility license to manufacture influenza vaccine for three months. Chiron has initiated discussions with the MHRA to determine the appropriate corrective actions, release from Chiron said.
"Chiron deeply regrets that we will be unable to meet public health needs this season. We take our responsibility to protect human health very seriously," bemoans Howard Pien, president and CEO of Chiron. "Chiron believes in the value of influenza vaccination, and we are committed to taking all necessary actions to ensure an adequate vaccine supply for the 2005-2006 influenza season," he added.
As a result of the license suspension, Chiron does not expect to record any sales of Fluvirin for the 2004-2005 season. Chiron disaffirms its previous full-year 2004 pro-forma earnings guidance of $1.80-$1.90 per share (a range of $1.50-$1.60 per share on a GAAP basis), including its August 2004 guidance of being in the low end of this range. Chiron currently expects pro-forma and GAAP earnings per share to be negatively affected by a range of $1.10-$1.15 as a result of today's announcement. Chiron currently expects full-year 2004 pro-forma earnings of between $0.70-$0.80 per share (a range of $0.35-$0.45 per share on a GAAP basis).
"Our manufacturing and quality staff have worked hard to resolve what we viewed as a problem limited in scope to a few batches, and we believe our quality assurance confirmatory testing demonstrates that the Fluvirin doses we anticipated releasing are safe. While the MHRA's conclusions are unexpected, we respect the regulatory authority's judgment," said John Lambert, president of Chiron Vaccines.
Chiron Vaccines is the world's second-largest manufacturer of influenza vaccines and has important meningitis, paediatric and travel vaccine franchises. Chiron Vaccines is the leading vaccine manufacturer in the United Kingdom, Germany and Italy.