Chiron still has a hurdle to climb before it can begin to re-supply its flu vaccine, Fluvirin, to the USA, according to a statement from the US Food and Drug Administration yesterday.
Although the US drug regulator found the Liverpool facility to be “generally acceptable,” it said additional work is needed to determine the amount of vaccine Chiron may be able to supply the US market for the upcoming flu season.
However, not to appear downbeat, Chiron said that this outcome – coupled with a thumbs up from the UK’s Medicines and Healthcare products Regulatory Agency [[03/03/05a]] – meant in could continue its efforts to return Fluvirin to the US market in time for the 2005/2006 flu season.
Chiron’s fortunes were damaged last year when the MHRA stopped shipments of Fluvirin after finding production defects at its Liverpool facility, halving the US stockpile of flu vaccines [[06/10/04b]]. The move caused a significant drop in the firm’s 2004 net income – from $304 million dollars the previous year to just $158 million [[28/01/05e]].
Chiron’s actions included improvements to the Fluvirin vaccine facilities, as well as equipment and processes. Therefore, the company says it must be win supplemental approvals from the FDA re-commencing the supply of Fluvirin to the US market. It also has the hurdle of successful production and final testing of the vaccine, plus a re-visit from the MHRA and FDA.
Whether it makes it to the market in time for the upcoming 2005/2006 flu season remains to be seen, but investors will likely be cheered on news that it is one step closer to this aim and that it has just received an offer from Novartis to acquire the remaining shares in the company [[01/09/05a]].