From PT NewsOnline: Chiron's QC problems extend to German plant

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More flu vaccine woes for Chiron, this time at plant in Germany...

18/07/2005 - Chiron's QC problems extend to German plant

Just as the flu vaccine production problems that have plagued Chiron's UK

plant seemed to have abated, the company has had to stop production at a

plant in Germany supplying the non-US market.

The firm said that its plant in Marburg had ceased production of the

vaccine, called Begrivac, and that this would reduce the number of vaccine

units it expects to ship to non-US markets from 12 million to four

million. This assumes it can meet its target of resuming production in

October and covering the shortfall with flu vaccine made at another

facility in Italy.

Last year, Chiron was forced to stop production of its Fluvirin vaccine at

its plant in Liverpool, UK, because of contamination problems, causing

significant vaccine shortages in the USA, the primary destination for the

vaccine . Since then, Chiron has been struggling to overcome the problems

and restart production at Liverpool, receiving the go-ahead to resume

production from the UK authorities in early March .

On Friday, Chiron announced that the FDA inspection of the Liverpool plant

had just got underway. Although the results of this inspection will not be

known for some weeks, Chiron said again that it expects to produce 18 to

26 million doses of Fluvirin for the 2005-2006 influenza season, with the

vast majority of the supply going to the US market.

The suspension last year has already contributed to a $304 million dollar

reduction in 2004 sales at the firm. Chiron also had to write off the

entire Fluvirin vaccine product inventory in the third quarter of the

year, resulting in a $91 million charge to cost of sales .

Worryingly, Chiron said in a press release that the problems at Marburg,

which mainly supplies the UK and German markets, seem to relate to quality

control failure related to sterility procedures, the same issue that

affected the Liverpool facility.

Chiron insisted that it does not need to change its financial guidance for

2005, even though it expects to record no sales of Begrivac in the third

quarter of the year.

Meanwhile, 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 trial included enough subjects to

prove it was effective .

© PharmaTimes 2000-2005

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