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Shire Continues to Deliver Excellent Growth From Core Products
Date:10/30/2009

ognition Procedure for an extension to the current indication for FOSRENOL as a treatment to control hyperphosphataemia in CKD patients who are not on dialysis and with a serum phosphorus level greater than or equal to 1.78mmol/L (5.5mg/dL). Pipeline Velaglucerase alfa - for the treatment of Gaucher disease - On July 30, 2009 Shire began the rolling submission with the FDA under Fast Track designation of a New Drug Application ("NDA") for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. On September 1, 2009 Shire reported that it had completed its NDA submission. Velaglucerase alfa is available ahead of its commercial launch, in the US via a treatment protocol and elsewhere on a pre-approval basis, to 300-600 patients in 2009 and will be available to several hundred more in 2010. REPLAGAL - for the treatment of Fabry disease - On October 21, 2009 Shire announced plans to file a Biologics License Application with the FDA for REPLAGAL (agalsidase alfa), its enzyme replacement therapy for Fabry disease, by the end of the year. The Company also announced that a treatment protocol for REPLAGAL, filed at the request of the FDA, has been approved, and that Shire will support emergency Investigational New Drug requests, in view of the announced supply restriction of the only currently marketed treatment for Fabry disease in the US. FIRAZYR(R) - for the treatment of hereditary angioedema ("HAE") - In September 2009 Shire initiated a clinical trial to investigate the safety of self-administration of FIRAZYR. Amicus collaboration for the development of pharmacological chaperones - On November 7, 2007 Shire licensed from Amicus Therapeutics Inc. ("Amicus") the rights to three pharmacological chaperone compounds in markets outside of the US: AMIGAL (
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Related medicine technology :

1. Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients
2. Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy
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)
8. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
9. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
10. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
11. Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
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