Sales of the REMINYL/RAZADYNE range, for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer's type, continue to grow in the Alzheimer's market.
Barr and other companies have filed an Abbreviated New Drug Application ("ANDA") with the US Food and Drug Administration ("FDA") for generic versions of RAZADYNE and Janssen and 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 at this time.
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. Janssen and Synaptech also filed suit against Sandoz Inc. in May 2007. No court date has been set in either proceedings.
Cost of product sales
For the six months to June 30, 2007 the cost of product sales was 14% of product sales (2006: 17%). The cost of product sales for REPLAGAL in 2006 included a $40.3 million adjustment in respect of inventories acquired through the acquisition of Transkaryotic Therapies Inc. ("TKT"). This fair value adjustment increased Shire's cost of product sales as a percentage of product sales for the six months to June 30, 2006 by 5%. Excluding the impact of this fair value adjustment in 2006, cost of product sales as a percentage of product sales in the six months to June 30, 2007 was 2% higher than for the six months to June 30, 2006 due to changes in the product sales mix and inventory write-offs.
For the six months to June 30, 2007 the cost of product sales included
|SOURCE Shire plc|
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