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Shire plc: Continued Strong Product Sales Performance in Q3: On Track to Deliver Significant 2011 Earnings Growth
Date:10/28/2011

ave initiated a program of investment to advance our pipeline and continue the international expansion of our portfolio. We continue to expect that combined R&D and SG&A for the full year will be around 20% higher than 2010, reflecting this investment program and the inclusion of ABH's cost base in 2011.

We anticipate our Non GAAP effective tax rate to be between 22 and 24% for the full year.

Overall, the operational leverage we expect to achieve for the full year will drive significant earnings growth in 2011, and we reiterate our aspirational growth targets.

THIRD QUARTER 2011 AND RECENT PRODUCT AND PIPELINE DEVELOPMENTS


 

Products


 

FIRAZYR® - for the treatment of acute attacks of Hereditary Angioedema ("HAE") in adults

  • On August 25, 2011 Shire announced that the U.S. Food and Drug Administration ("FDA") had granted marketing approval for FIRAZYR in the US for treatment of acute attacks of HAE in adults 18 years of age and older. After injection training, patients may self-administer FIRAZYR, the first and only self-administered subcutaneous treatment for acute HAE. FIRAZYR has orphan drug designation status in Europe and the US for the treatment of acute HAE.


 

VPRIV® and REPLAGAL® Manufacturing Update

  • Shire has completed process validation runs for VPRIV at its new Lexington manufacturing facility and intends to file for regulatory approvals starting in November 2011. Approval for the manufacture of VPRIV at the Lexington facility is anticipated in early 2012 and will significantly increase Shire's manufacturing capacity for VPRIV. In addition, this approval will release further capacity for the manufacturing of REPLAGAL at Shire's Alewife facility where both VPRIV and REPLAGAL are currently manufactured.

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