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GSK drug split fixed

GlaxoSmithKline believes it has identified the source of the manufacturing problem that caused certain stocks of sub-standard Paxil CR and Avandamet.

GlaxoSmithKline believes it has identified the source of the manufacturing problem that caused certain stocks of sub-standard Paxil CR and Avandamet to be seized by the FDA in March this year.

The firm said it has implemented revisions to the manufacturing processes for both drugs, which suffered from a splitting problem. Both products were manufactured at GSK's Cidra plant in Puerto Rico, where their production was halted on the recommendation of the US Food and Drug Administration (FDA) earlier in the year.

In March, an inspection by the FDA revealed that affected Paxil CR tablets could split apart, which may result in patients receiving treatment that does not contain the active ingredient; alternatively, they could receive part of the drug containing the active components but not the compound necessary for its controlled release, the FDA concluded.

In the case of Avandamet, the FDA found that tablets did not contain an accurate dose of the active ingredient, rosiglitazone.

However, GSK has now signed a Consent Decree with the FDA that provides for an independent expert to review manufacturing processes at the site to assess compliance with FDA Good Manufacturing Practice requirements.

It also requires the company to provide a report to the FDA on any deficiencies that may be identified in the independent review, setting out a corrective plan and timetable for completion.

ìThe Consent Decree show that the FDA is serious about enforcing manufacturing standards essential for safe and effective prescription drugs,î noted John Taylor, FDA associate commissioner for regulatory affairs.

A spokesman for GSK told Pharmaceutical Marketing that only a `handful' of Paxil CR tablets were splitting and these had been removed by hand - a solution that was working well for the company. He added that the 1mg dose of Avandamet, in which the small molecules had been `clumping', had already been withdrawn from the market.

The firm said it expects to have both drugs back on the market sometime in mid 2005.

The FDA admitted that it was not aware that patients have been harmed by the drugs and no financial penalties have been imposed on GSK under the Consent Decree, although it does require that GSK posts a penal bond of $650m contingent upon its adhesion to the FDA's stipulations in dealing with the seized drug batches.

Furthermore, it allows for future penalties of up to $10m a year if the company fails to meet the terms of the agreement.

Separately, GSK has announced a strong Q1 `05 performance which saw a profit boost of 18 per cent (to £1.7bn). This was due in large part to strong performances by its Advair asthma treatment and Avandia, for diabetes, as well as a 5 per cent increase in sales (to $5bn). The firm also received a £140m injection through the return to Bayer of co-marketing rights for erectile dysfunction drug, Levitra.

CEO, Jean-Pierre Garnier, was confident that the firm is on track to hit a forecast double-digit increase in earnings during 2005.

30th September 2008

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