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GSK updates on facility problems

04-Apr-2005

GlaxoSmithKline was unable to give a timeline for resolving the manufacturing problems at its plants in the US and Puerto Rico at an analyst meeting last week, but has been able to transfer production to another site.

The UK-headquartered company had stocks of two drugs - the diabetes drug Avandamet (rosiglitazone and metformin) and antidepressant Paxil CR (paclitaxel) - seized by the US Food and Drug Aministration (FDA) last month for failing to comply with manufacturing standards.

GSK's president of pharmaceutical operations, David Stout, gave an update on the situation at Lehman Brothers Eighth Annual Global Healthcare Conference in Miami, US, last week.

 

Stout said GSK believed that it had satisfied the long-running FDA issues prior to the seizures of the drugs by conducting a recall last year, but this was clearly not the case. But he told the meeting that that the agency has given no indication of an issue beyond Paxil and Avandamet and that it has said it has 'great respect' for GSK's manufacturing standards as a whole.

 

Lehman analysts have said that GSK has since moved production of Avandamet to a facility in Spain to satisfy the rapidly growing European market for the drug.

 

However, this facility is not approved by the FDA to supply the US market, so cannot be used to offset US shortages. Stout put the action into perspective, however, by noting that sales of Paxil CR and Avandamet account for £396m and £222m respectively out of total sales of £17.1bn in 2004.

 

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