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GSK Regulatory Update on Avandia Following EMA and FDA Reviews
Date:9/23/2010

n and support from healthcare professionals and patients.  

Regarding clinical trials, the FDA has imposed a new post-marketing requirement (PMR) for GSK to commission an independent reajudication of the endpoints reported in the large, prospective, randomized, controlled study, RECORD. GSK will provide its full support for this review. The FDA-required TIDE study has been placed on full clinical hold by the agency.  TIDE is the only GSK-sponsored clinical trial using Avandia currently being conducted in the US and Europe.  GSK in conjunction with the TIDE steering committee will communicate this decision to local regulatory agencies, ethics committees and institutional review boards (IRBS).

Financial Information

Total Avandia sales in the first half of 2010 were 321m pounds Sterling (-18%); US 164m pounds Sterling (-23%); Europe 72m pounds Sterling (-17%); Emerging Markets 37m pounds Sterling (-5%); RoW 48m pounds Sterling (-6%)**.  As a result of the regulatory updates in both the US and EU, GSK now expects global sales of Avandia products to be in a range of approximately 100m pounds Sterling - 150m pounds Sterling in the second half of 2010 and with minimal annual sales thereafter. These estimates are net of customer returns of product previously sold.  Associated one-off costs in 2010 comprising stock write-offs, asset write-offs and other related one-off costs are currently expected to be approximately 100m pounds Sterling on a pre-tax basis. 

To access the full EMA announcement visit www.ema.europa.eu.  

To access the full FDA announcement visit www.fda.gov.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For fur
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SOURCE GlaxoSmithKline
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