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Shire Delivers Strong First Quarter Performance and Reiterates its Expectation of Good Full Year Earnings Growth
Date:4/26/2012

was adopted by the European Commission on March 26, 2012. Shire now has two EMA approved facilities - Alewife in Cambridge, Massachusetts, as well as the new Lexington facility - in which to manufacture VPRIV drug substance.

Shire has received a Complete Response letter from the US Food and Drug Administration ("FDA") regarding production of VPRIV drug substance at Lexington. Shire is working closely with the FDA to address their questions and resolve any outstanding issues to the satisfaction of the agency.

Notwithstanding the ongoing discussions with the FDA, Shire continues to supply VPRIV to US patients through its existing approved US manufacturing facility at Alewife and has the capacity to meet the anticipated demand for VPRIV from existing and new patients both in the US and globally, recognizing that US inventory levels will be below target levels until the Lexington facility is approved by the FDA.

VYVANSE - for the treatment of Attention Deficit Hyperactivity Disorder ("ADHD")

  • On March 6, 2012 Shire announced that it is initiating two Phase 4 clinical trials to compare VYVANSE Capsules to CONCERTA® Extended-Release Tablets. These prospectively designed head-to-head clinical trials will provide important information for physicians, patients, caregivers, and payors to make informed choices, and have been designed to explore differences in efficacy between VYVANSE and CONCERTA in adolescents aged 13 to 17 with ADHD. Together the two trials will enroll approximately 1,000 patients, and results are expected in the second half of 2013.

FOSRENOL® - for the treatment of Hyperphosphatemia in end stage renal disease

  • On March 8, 2012 Shire announced that it has received approval through the European Decentralised Procedure for an oral powder formulation of FOSRENOL. The oral powder formulation
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SOURCE Shire plc
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3. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
4. Shires Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
5. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
6. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
7. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
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10. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
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