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GSK suffers Avandia sales drop

GlaxoSmithKline has announced a 22 per cent drop in Avandia sales for Q2 FY07, following a meta-analysis published in May that linked the drug to cardiovascular side effects.

GlaxoSmithKline (GSK) has announced a 22 per cent drop in Avandia sales for Q2 FY07, while its 2007 earnings outlook remains unchanged although this could change once it has met with the US Food and Drug Administration (FDA) next week to discuss the drug.

Sales of Avandia have fallen to GBP349m following the publication in May in the New England Journal of Medicine (NEJM) of a meta-analysis linking the drug to an increased risk of cardiovascular side effects. GSK says it strongly disputes the research's findings and has carried out its own clinical trials involving over 52,000 patients.

On 30 July the FDA will hold an Advisory Committee meeting to discuss the potential cardiovascular risks associated with Avandia and other thiazolidinedione (TZD) class drugs.

GSK has submitted epidemiological data to the FDA it says it has underscored the safety profile of Avandia ahead of the meeting.

Jean-Pierre Garnier, CEO, said: "GSK has delivered a good earnings performance in a challenging quarter. Whilst some uncertainty remains around Avandia, we stand firm in our belief that it is an effective and valuable treatment for patients with diabetes. We continue to see very good progress across the rest of our portfolio with the successful launch of alli and five major pharmaceutical products already completed this year.î

For the week-ending 13 July 2007, Avandia's share of new and total retail prescriptions in the oral anti-diabetic market was 6.2% and 7.4%, respectively compared with shares of 11.5% and 11.7% respectively for the week-ending 18th May 2007. These represent decreases of approximately 46 per cent and 37 per cent in the volume of new and total prescriptions since the publication of the meta-analysis.

Performance was most affected in the US, where sales dropped 31 per cent to GBP226m. According to Novartis, US sales growth was impacted by comparison to a strong performance in Q2 2006, when sales grew by 33 per cent, which benefited from restocking of Avandia (rosiglitazone maleate) and Avandamet (Avandia plus metformin).

Sales in Europe grew 20 per cent to GBP63m because of a growing use of Avandamet. The published meta-analysis has limited impact on its sales, although sales in international markets declines 9 per cent to GBP60m.

25th July 2007

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