Royalties from sales of ZEFFIX for the year to December 31, 2007 were US$41.0 million, an increase of 18% compared to the same period in 2006 (2006: US$34.8 million). The impact of foreign exchange movements has contributed 8% to the reported growth; excluding favourable foreign exchange movements there has been an increase of 10% compared to the same period in 2006.
Shire receives royalties from GSK on worldwide ZEFFIX sales. GSK's worldwide sales of ZEFFIX for the year to December 31, 2007 were US$341 million, an increase of 13% compared to the same period in 2006 (2006: US$301 million). This increase was mainly due to strong growth in the Chinese market and favourable foreign exchange rate movements.
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 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.
Janssen and Synaptech filed lawsuits against Barr and Sandoz Inc. ("Sandoz") for infringement of their patent rights relating to RAZADYNE ER as a result of Barr and Sandoz filing ANDAs with the FDA for generic versions of RAZADYNE ER. No court dates have been set.
Cost of sales
For the year to December 31, 2007 the cost of sales was 14% of product
sales (2006: 16%). The cost of sales for REPLAGAL in 2006 included a
US$47.0 million (3% of product s
|SOURCE Shire plc|
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