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 [[06/10/04b]]. 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 [[03/03/05a]].
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 [[28/01/05e]].
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 [[07/06/05c]].
