Although US biotechnology company, Chiron, hopes to be able to provide its Fluvirin flu vaccine for the 2005/6 flu season, it says it is difficult to predict the number of doses it will be able to produce.
Chiron had its manufacturing licence suspended last October by the UK Medicines and Healthcare products Regulatory Agency after deficiencies were uncovered at its Liverpool plant [[06/10/04b]], but was given the nod earlier this week by the UK regulators to restart production [[03/03/05a]]. The company must provide weekly updates to the MHRA on the plant’s progress, and will have to wait for a full US Food and Drug Administration inspection when all stages of manufacturing are in full swing, before it can resume US sales of the vaccine.
Speaking at an analyst and investor conference yesterday, the company’s chief executive, Howard Pein, said that the firm was “going full force ahead towards the start of full commercial production.” However, he cautioned that, because of the complexity of the manufacturing process, it was too early to forecast both the number of doses the company hoped to produce, and financial guidance for the coming year, which remains largely dependent on Fluvirin. Chiron’s net income for 2004 sank after the firm was not able to record any Fluvirin sales in either the third or fourth quarters of the year [[28/01/05e]]. It also had to write off the entire Fluvirin vaccine product inventory in the third quarter, resulting in a $91 million charge to cost of sales.
Mr Pein said the firm was aiming to provide financial guidance when it unveils its first quarter earnings in April.