Second Chiron plant has sterility problems
of influenza vaccine it will be able to ship to markets outside the
US as a result of sterility problems uncovered at another of its
manufacturing plants, reports Phil Taylor.
The company is only just starting to emerge from the serious production problems at its facility in Liverpool, UK, which had to cease production of the Fluvirin flu vaccine last year as a result of contamination problems. Now it seems that similar issues are affecting Chiron's plant in Marburg, Germany, which produces another flu vaccine, Begrivac, intended primarily for the UK and German markets.
Chiron said it had ceased production and shipments of Begrivac at Marburg, but would now have to reduce its supply if the vaccine from around 12 million doses to just four million for the coming 2005/6 flu season.
The problems at its Liverpool plant seem to be on the wane, with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) giving the go-ahead for the firm to resume production in February. However, the debacle hit Chiron's finances last year to the tune of $304 million, and left the US struggling to meet a shortfall in flu vaccine supply in what was luckily a mild flu season. The company also had to write off the entire Fluvirin vaccine product inventory in the third quarter of 2004, resulting in a $91 million charge to cost of sales.
However, Chiron is insisting that the problems at Marburg will not force it to change its earnings forecasts for 2005, which have already been trimmed back because the company has been unable to get Fluvirin production at the Liverpool facility up to speed as quickly as hoped. A lot will depend on the outcome of a US Food and Drug Administration (FDA) inspection of the facility, which has just got underway but is not likely to deliver a final verdict on the state of manufacturing at the plant for several weeks.
In a statement, Chiron said that it was hoping to resume production of Begrivac in October, providing corrective action, on which it is working closely with the German regulatory agency, the Paul Ehrlich Institute (PEI), proceeds according to plan. The company and the PEI are currently carrying out additional testing in order to determine the full extent of the issue.
In the interim, Chiron is planning to divert supplies of other flu vaccines in its portfolio, made at a facility in Siena, Italy, to spread available supplies of flu vaccine across its non-US markets. Siena produces Agrippal S1 and Fluad influenza virus vaccines, and will boost production to help mitigate the situation, said the firm.
Pulminiq needs another clinical trial
And in more bad news for the company, Chiron has said it is facing a delay before it can launch a new product for reducing rejection of in lung transplant patients.
Chiron will have to carry out additional clinical work to prove that its inhaled therapy to prevent lung transplant rejection - Pulminiq (cyclosporine) - is effective, according to the US Food and Drug Administration. An FDA advisory panel said last June that the therapy seemed safe but questioned whether the 56-patient trial included enough subjects to prove it was effective.
