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Further Upgrade to 2007 Financial Guidance Based on Strong Revenue Growth; VYVANSE Demand on Track
Date:11/1/2007

ZEFFIX sales. GSK's worldwide sales of ZEFFIX for the three months to September 30, 2007 were $87 million, an increase of 9% compared to the same period in 2006 (2006: $80 million). This increase was mainly due to strong growth in the Chinese market and favorable foreign exchange rate movements.

Other

Other royalties are primarily in respect of REMINYL and REMINYL XL (known as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide (excluding the UK and the Republic of Ireland) by Janssen Pharmaceutical N.V. ("Janssen"), an affiliate of Johnson & Johnson. Shire has the exclusive marketing rights in the UK and the Republic of Ireland.

Barr and other companies have filed Abbreviated New Drug Applications ("ANDA") with the FDA for generic versions of RAZADYNE. Janssen and Synaptech Inc. ("Synaptech") have filed lawsuits against some of those ANDA filers. A trial was held during the week of May 21, 2007. No decision from the court has been issued to date.

In June 2006 Janssen and Synaptech filed a lawsuit against Barr for infringement of their patent rights relating to RAZADYNE ER as a result of Barr filing an ANDA with the FDA for a generic version of RAZADYNE ER. In May 2007 Janssen and Synaptech also filed suit against Sandoz Inc. as a result of Sandoz Inc. filing an ANDA with the FDA. No court date has been set in either proceedings.

4. Financial details

Cost of product sales

For the three months to September 30, 2007 the cost of product sales was 15% of product sales (2006: 16%). The cost of product sales for REPLAGAL in 2006 included a $6.7 million adjustment in respect of inventories acquired through the acquisition of TKT. This fair value adjustment increased Shire's cost of product sales as a percentage of product sales for the three months to September 30, 2006 by 2%. Excluding the impact of this fair value adjustment in 2006, cost of product sales as a percentage of product sales in the three months to Septe
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SOURCE Shire plc
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