All initial launch stocks of VYVANSE totaling US$57.8 million were recognised into revenue during the year to December 31, 2007.
DAYTRANA - ADHD
Product sales for the year to December 31, 2007 were US$64.2 million (2006: US$25.1 million). DAYTRANA's average share of the US ADHD market increased to 2.1% in 2007 compared to 0.8% in 2006 (DAYTRANA was launched in June 2006). US prescriptions of DAYTRANA for the year to December 31, 2007 over 2006 benefited from a full year of demand, 6% growth in the US ADHD market and higher market share. For the six month period to December 31, 2007 prescriptions of DAYTRANA were up 31% compared to the same period in 2006. During September 2007 Shire announced a voluntary market withdrawal of a limited quantity of DAYTRANA patches following feedback from patients and caregivers who had experienced difficulty in removing the release liner. Patches are now being manufactured using an enhanced process, which Shire believes offers improved ease of use when peeling off the release liner.
On January 9, 2008 the US Food and Drug Administration ("FDA") issued a warning letter to Noven Pharmaceuticals Inc. ("Noven"), which related to Noven's manufacture of DAYTRANA. Further regulatory action could result if the FDA's concerns are not satisfied fully. Noven submitted a response to the FDA on January 30, 2008 and the FDA responded on March 14, 2008 indicating that Noven's responses appear to be satisfactory. It is expected that the FDA will perform a follow-up FDA inspection of Noven's manufacturing plant to ensure compliance.
The addition of VYVANSE combined with ADDERALL XR and DAYTRANA's market
share helped Shire grow its total share of the US ADHD market to 31.1% at
December 31, 2007 compared to 28.0% at Decem
|SOURCE Shire plc|
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