In 2007 generic drug companies filed Abbreviated New Drug Applications ("ANDA") seeking approval for EPIVIR, COMBIVIR, ZEFFIX and EPZICOM in the US. Pursuant to the GSK/Shire license for lamivudine products, GSK has the right to enforce the licensed patents. In November 2007 GSK filed a patent infringement lawsuit against Teva Pharmaceuticals, Inc. (Teva) in the US District Court for the District of Delaware for infringement of one of the patents relating to COMBIVIR. The patent, which covers the combination of AZT and lamivudine to treat HIV, expires in May 2012. Teva had filed an ANDA with the FDA with a certification of invalidity, unenforceability and non-infringement of that combination patent. Teva did not challenge two other patents relating to COMBIVIR that expire in 2010 and 2016. The case is in its early stages.
ZEFFIX - Chronic hepatitis B infection
Royalties from sales of ZEFFIX for the year to December 31, 2007 were $41.0 million, an increase of 18% compared to the same period in 2006 (2006: $34.8 million). The impact of foreign exchange movements has contributed 8% to the reported growth; excluding favorable 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 $341
million, an increase of 13% compared to the same period in 2006 (2006: $301
million). This increase was mainly due to strong growth in the Chinese
market and favor
|SOURCE Shire plc|
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